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A rare or orphan disease is defined in the US as one that affects fewer than 200,000 at any given time. It is estimated that there are 6000 to 8000 rare diseases in the world today. Because the number of patients afflicted with orphan diseases is so small, drug companies have historically been reluctant to invest money to discover and develop new treatments for them. The dearth of treatments for rare diseases induced Congress to pass the Orphan Drug Act in 1983 which provided market exclusivity, tax breaks and incentives and regulatory help for companies to development new drugs for orphan disease indications.

While many current blockbuster drugs including recombinant human insulin, growth hormone and erythropoietin originally garnered regulatory approval after receiving orphan status in the late 1980s, most big pharma and biotechnology companies (except Genzyme) largely abandoned orphan drug development until recently. The renewed interest in orphan drug development has been primarily driven by the demise of big pharma’s blockbuster business model that began in the early 2000s. The search for new, non-blockbuster drugs and fresh markets is what induced Pfizer, the world’s largest pharmaceutical company, to recently inked a multimillion dollar deal with Protalix Biotherapeutics, a small biopharmaceutical company developing a new treatment for Gaucher disease—an orphan indication.

Because of renewed interest and the ever increasing need for new orphan drugs, the FDA’s Office of Orphan Products Development is offering an Orphan Drug Designation Workshop that will provide a unique opportunity for all potential drug sponsors—including biotechnology companies, pharmaceutical firms and academic institutions—to learn about the application process for orphan drug designation.

The National Organization for Rare Disorders (NORD) is a co-sponsor of the workshops, which will take place on February 25-26 at Keck Graduate Institute and August 3-4 at the University of Minnesota.

Participants are encouraged to bring specific product proposals for at least one candidate orphan drug that holds promise for the treatment of a rare disease. A significant portion of the workshop will be dedicated to preparing applications, including one-on-one guidance sessions with FDA staff members. FDA will keep product and disease information confidential.

Final applications can be submitted to the FDA at the close of each workshop. For information or to register:

FDA Workshop Brochure
Registration for the February Workshop

Finally, February 28^th is Rare Disease Day. The event is sponsored by the EURODIS a European advocacy group that promotes awareness and research for rare diseases. NORD and Discovery Health are also sponsoring the day.

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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Theravance Inc. announced Thursday US Food and Drug Administration (FDA) regulators are not satisfied with new data on its infection drug candidate telavancin (Vibativ), and indicated that further clinical studies may be required to win marketing approval.

Approval of Vibativ has been held up for three years, as the Food and Drug Administration asked the company for more data about the drug, and about studies Theravance has conducted in support of its application to the FDA. Theravance said Thursday the FDA told it the data so far is not enough to prove Vibativ works.

The agency will not begin a formal review of the drug until it says it is satisfied with the data.

Vibativ, or telavancin, is an injection intended to treat complicated or drug-resistant infections like methicillin-resistant Staphylococcus aureus (MRSA). Theravance submitted an NDA to FDA for review in December 2006.

According to Theravance, the FDA did not say Theravance would have to run a new clinical trial to gain approval, but it suggested a design for such a study. Company representative said that they do not know what the FDA wants and said the agency did not provide any suggestions about the goals of the proposed study, how many patients should be included, or even how many studies might be required ( I guess it may be time for a meeting to discuss these issues?).

In response to the FDA’s previous requests for more data on telavancin, Theravance said it combined data from two late stage trials of Vibativ, with the goal of making the data more comparable. It said the FDA told it that the data is equal to only one study. Two late-stage trials are often required to win approval.

Theravance said it has tested Vibativ on about 1,500 patients and said its studies are the largest that have been submitted in support of a new drug of its type.

Regulatory concerns about Vibativ include a risk of birth defects when it is used in pregnant women, manufacturing issues, and questions about data comparing the drug to vancomycin, which is the most powerful antibiotic currently on the market.

While getting new antibiotics are the market are important, clinical studies must be carefully designed with appropriate endpoint to address potential safety and efficacy issues. Although Theravance believes that it has done that, the agency, as always, will be the final arbiter of a decision on telavancin.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

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Harrison Ford’s new movie “Extraordinary Measures” (also starring Brendan Fraser) is loosely based on John Crowley’s ongoing crusade to find a cure for Pompe Disease a genetically inherited illness that afflicts two of his three children.The film chronicles the 'extraordinary measures' taken by Crowley to find a treatment for the so-called orphan disease that affects the lives of about 40,000 persons worldwide. While I haven’t seen the film, it bears a striking resemble to the 1992 film “Lorenzo’s Oil” which chronicled the struggles of two parents to find a “cure” for their son’s adrenoleukodystrophy an another orphan disease.

Crowley’s story began about 12 years ago when his oldest child was diagnosed with Pompe Disease. For those of you who may not know, Pompe Disease is a progressive, multisystemic, debilitating, and often fatal neuromuscular disorder. The disease is linked to an inherited deficiency of the lysosomal enzyme acid alpha-glucosidase (GAA), which is responsible for the breakdown of glycogen inside the cells. The result is intralysosomal accumulation of glycogen, primarily in muscle cells, that leads to a progressive loss of muscle function and ultimately death. At the time of the diagnosis, Crowley, a Princeton, NJ resident, was working as a marketer for Bristol Myers Squibb. He quickly learned that there was no effective treatment for Pompe Disease and that his daughter may not live beyond early childhood. Further, because the disease afflicted so few individuals, no pharmaceutical or biotechnology companies were working on treatments for Pompe Disease. 

To stave off the likelihood of his daughter’s death, in 2000, Crowley raided his 401k plan and mortgaged his home to start a company called Novazyme that focused exclusively on developing treatments for Pompe Disease. Having no time to waste, Crowley and the Novazyme team worked feverishly to develop an alglucosidase alfa enzyme replacement therapy for Pompe. By 2001, the Novazyme team had identified a likely treatment and Crowley sold his company to Genzyme. As a senior vice president at Genzyme, he oversaw clinical development of the product which is now called Myozyme and is the first FDA-approved treatment for Pompe Disease. Crowley left Genzyme in 2004 and is currently CEO of Amicus Therapeutics a 100 person company focused on developing new treatments for Pompe Disease and other orphan indications.

At present, there are no other treatments besides Myozyme for Pompe Disease. This is because Pompe Disease is designated as an orphan indication and Genzyme received seven years of market exclusivity for Myozyme as stipulated in the Orphan Drug Act. Myozyme received FDA approval in 2006.

While Genzyme has been the only player in the Pompe Disease market for the past four years, manufacturing and scale up problems threaten to jeopardize the Myozyme franchise. Genzyme’s highly publicized problems at its Allston, MA-manufacturing facility have been well documented and Genzyme’s management team is taking bold steps to correct them (including hiring a new senior vice president for global product quality) and entering into an agreement with Hospira Worldwide Inc to provide fill and finish manufacturing services.

But perhaps more troubling, were the problems that the company experienced when attempting to scale up Myozyme production from the 160L to 200L bioreactor scale to meet growing demand for the drug.  FDA informed Genzyme that that Myozyme® (alglucosidase alfa) produced at the 160L bioreactor scale and Myozyme produced at the 2000L scale should be classified as two different products because of differences in the carbohydrate structures of the molecules. And, the company would have to file a new biologics application (BLA) for the 2000L product to garner regulatory approval.

Currently, Genzyme has U.S. approval to sell Myozyme manufactured at the 160L scale, and the company has been seeking clearance from the FDA for Myozyme produced at the 2000L scale (now marketed as Lumizyme). Lumizyme has already been approved in more than 40 countries. However, manufacturing problems and violations at the Allston facility forced FDA to delay a decision on the approvability of Lumizyme this past March. Earlier this week, Genzyme announced that FDA will issue a new decision on Lumizyme in June.

While originally spurned by large drug companies, orphan drug development is becoming much more attractive because of the lack of new blockbuster drugs in most company’s development pipeline. According to a recent report, the number of orphan product designations in the US more than doubled in the last decade rising from 208 in the 2000-02 periods to 425 in 2006-08. More recently, Pfizer, the world’s largest pharmaceutical company announced that it agreed to pay at least $60 million for rights to Protalix Biotherapeutics Inc.'s new treatment (taliglucerase alfa) for Gaucher’s Disease another orphan indication. This suggests that Pfizer has made a decision to directly compete with Genzyme, the world leader in orphan drug development.

Don’t be surprised when other large pharmaceutical and biotechnology companies announce plans to compete in the orphan drug market...there is money to be made!

Until next time...

Good Luck and Good Job Hunting!!!

 

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As Jonathan Richman, author of the Dose of Digital blog focused on pharmaceutical marketing aptly put it, its time to “stop talking about social media.” “To recap, in 2009 we demanded the FDA call a hearing to discuss social media…and they did! We wrote and read hundreds, if not thousands, of articles on social media. We transformed (read: hijacked) every digital marketing conference into a social media conference. We launched a ton of social media programs even if they represent a conservative start.”

While I am still an ardent social media enthusiast and supporter, I agree with Jonathan that it may be time to sit back, relax and reflect a little bit until FDA enlightens us with their first round of guidance on social media and the life sciences industry. Having said that, I am certain that the agency’s first iteration will provide us bloggers with sufficient fodder to write about and ignite round 2 of the discussion. In the meantime, @Skypen of Ignite Health graciously created a website called Everything About the FDA, Internet & Social Media that provides updates, commentary and even tweets (#FDASM) about FDA progress or lack thereof.

I think that social media has a role to play in the life sciences industry. However, the role has yet to be defined mostly because of the lack of regulatory guidance in the area.

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

 

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For many years, I taught medical students that the emergence of antibiotic resistant strains of bacteria primarily resulted from the overuse and misuse of antibiotics by physicians. While this seemed to make sense, I started chatting in the late 1990s with Steve Projan— a well known and highly respect maven on bacterial antibiotic resistance—who told me that the physician story was an urban legend and that the main reason for the emergence of antibiotic resistance was directly related to the use of antibiotics as growth enhancers in livestock feed. Not surprisingly, shortly after my conversations with Dr. Projan, papers began appearing in the literature that corroborated the claims.

Despite a growing body of convincing scientific evidence, the Bush administration did nothing to regulate or reduce the use of antibiotics in live stocks feeds in the US for almost a decade. Last year it is estimated that 35 million pounds of antibiotics were used in the US. Interestingly, 70% were used in cows, chickens and pigs. It is important to point out that the US isn’t the only culprit; recent estimates suggest that 50% of the global antibiotic supply is used by the livestock industry. Recognizing a growing problem, the European Union and other developed countries (not the US) have adopted strong limits on the use of antibiotics for livestock purposes.

Thankfully, the pressure against the use of antibiotics in agriculture and livestock production is rising. The World Health Organization concluded this year that surging antibiotic resistance is one of the leading threats to human health, and the White House last month said the problem is "urgent." Also this year, the three federal agencies tasked with protecting public health — the Food and Drug Administration (FDA), CDC and U.S. Department of Agriculture — declared drug-resistant diseases stemming from antibiotic use in animals a "serious emerging concern." And, this past summer, FDA deputy commissioner Dr. Joshua Sharfstein told Congress that farmers need to stop feeding antibiotics to healthy farm animals.

Pharmaceutical companies and agricultural lobbyists argue that antibiotics keep animals healthy and meat costs low, and have successfully help to defeat a series of proposed limits on their use. To that end, in 2009, drug makers spent $135 million and agribusiness companies another $70 million, lobbying against new limits on the use of antibiotics as livestock growth enhancers. FDA official say that without new laws the agency’s options are fairly limited. Ironically, the agency approved antibiotic use in animals in 1951, before concerns about drug resistance were recognized. And, the only way to withdraw that approval is through a drug-by-drug process that can take years of study, review and comment.

Previous attempts by FDA to limit antibiotic usage have consistently met with limited success. For example, in 1977 the agency proposed a ban on penicillin and tetracycline in animal feed, but it was defeated after criticism from interest groups. In 2000 FDA ordered the antibiotic Baytril (used in the poultry industry) off the market. Five years later, after a series of failed judicial appeals, poultry farmers finally stopped using the drug as a growth enhancer. Finally, in 2008 the FDA issued its second limit on an antibiotic used in cows, pigs and chickens, citing "the importance of cephalosporin drugs for treating disease in humans." But the Bush Administration — in an FDA note in the federal register — reversed that decision five days before it was going to take effect after receiving several hundred letters from drug companies and farm animal trade groups.

Luckily, we now have a President who believes in regulation of big business to protect the health and welfare of Americans and is smart enough to make the scientific connections between emerging antibiotic resistance in animals and human. Maybe some real change will be coming soon....one can only hope!!!!!!!!!!

Hat tip to Ed at the Pharmalot Blog

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Mark Senak, author of the EyeonFDA blog and “all around good guy,” has created a Twitter list that follows the tweets of all of the pharmaceutical companies that use Twitter. Because the list of companies that are currently using Twitter is so small, it is a convenient aggregation tool to monitor the musings and tweets of companies that participate! 

 Hat tip and shout out to Mark!

Until next time....

Good Luck and Happy Holidays!!!!

 

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Jonathan Richman, author of the Dose of Digital Blog, got it exactly right in today’s post  entitled “Patients WILL Have the Final Say on Pharma Social Media” He was spot on with his conclusion that while social media pundits and patient advocacy groups can push FDA to attempt to provide guidance on the use of social media, in the end, it will be patients (customers) not regulators who determine whether or not pharma will incorporate social media into future business models. Recently, it has been pointed out (on Twitter of course) that patient advocacy groups were under represented at the recent public FDA hearings on social media. While this is true, it likely will have little bearing on the regulatory guidance ultimately issued by the agency. This is because public input is generally not used to fundamentally shape regulatory guidance or policies but to fine tune them! The agency generally has a regulatory framework in mind before it conducts public hearing to collect stakeholder input and comments.

As I mentioned in previous posts, FDA intentionally crafts regulations and guidelines that are subject to interpretation because they are meant to serve as the minimum regulatory requirements and standards that must be met to insure drug and device safety and efficacy. While this is not ideal for many corporate regulatory affairs professionals, it is necessary because the agency simply cannot provide specific or custom-designed guidance to the plethora of drug and device manufactures that it oversees.  In other words, the regulations that FDA crafts are meant to serve as general regulatory frameworks not clearly defined, company-specific rules and regulations. Companies that struggle with interpretation of FDA regulations are encouraged to meet with FDA regulators for guidance and clarification. More importantly, while FDA is charged with insuring the safety and efficacy of drugs and devices, the agency has very little control over how companies choose to interact with patients, customers and stakeholders. For example, companies ARE NOT required to submit direct-to-consumer (DTC) ads, marketing and advertising campaigns or other promotional materials for FDA review. This means that drug and device manufacturers have enormous flexibility in choosing how to market, advertise and promote approved products. FDA regulators only get involved when the agency is alerted to the possibility that certain ads or promotional materials may contain inappropriate, misleading or inaccurate medical information or claims. When a company is “snagged” by FDA for suspect marketing practices, the agency generally imposes mandatory regulatory review (for a defined period of time) of all subsequent DTC and promotional campaigns developed by the transgressor. To that end, the lack of patient advocacy testimony at the recent FDA hearings on social media should have little or no impact on the guidance that FDA ultimately issues.

While the much anticipated guidance ought to provide a regulatory framework for companies that choose to use social media, it can not “force” drug and device manufacturers to adopt or use it. This will be a corporate decision that will likely be made by legal, regulatory and marketing pharmaceutical executives. Finally, as Jonathan rightly points out, the needs and demands of patients will ultimately determine whether or not a drug or device manufacturer implements a social media strategy. And, not surprisingly, this decision will likely be based on drug sales and business outcomes rather than a need for patient education or public safety. Because—at the end of the day—business is business!

Hat tip to Jonathan!

Until next time...

Good Luck and Good Tweeting!!!!!!!!!

 

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Earlier this week, Mark Senak who writes the EyeonFDA blog, offered his insights and analysis of pharma’s relationship with Twitter. Today, he tackled YouTube and Pharma. While YouTube has been around a lot longer than Twitter, pharma’s use (with the exception of Johnson and Johnson, Sanofi-Aventis and Tibotec) of the popular video-sharing site has been extremely limited despite the ability of the entity that posts the video to eliminate or regulate the ability of users to leave and share comments after viewing it. 

I suspect that the industry’s reluctance to use YouTube may be related to the lack of regulatory guidance for this medium. Nevertheless, I don’t completely understand why drug makers have chosen not to use the widely popular video site to increase patient awareness about certain medical conditions or to promote patient wellness. These types of videos would likely be appreciated by the public and quite possibly help to repair tarnished image of the pharmaceutical industry held by many consumers and stakeholders.

Hat tip to Mark!

Until next time....

Good Luck and Good Viewing!!!!!

 

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I was chatting with a fellow medical writing colleague the other day and the topic of direct-to-consumer (DTC) advertising came up. I suggested that DTC advertising is largely ineffectual but my colleague suggested otherwise. To prove his point, he sent me a fascinating article entitled “Direct-to-Consumer Advertising: An Attitude Survey of Psychiatric Physicians (Bhanji et al. Primary Psychiatry. 2008; 15(11):67-71). The conclusion of the paper was somewhat surprising (to me anyway):

......pilot survey of psychiatrists revealed that DTC advertising has the potential to improve awareness of medical conditions and decrease the stigma of mental illness. Surveyed psychiatrists believed that DTC had little significant effect on their personal prescribing practices. However, >80% of respondents reported they had prescribed medications specifically requested by their patients. Most respondents failed to endorse that DTC had a positive effect on the doctor-patient relationship, or on improved patients’ medication compliance.

This suggests that people (at least those suffering from mental illness) listen to and likely learn about their illnesses from DTC ads. Further, it explains why drug makers continue to spend large sums of money on DTC advertising despite diminishing ROI on traditional print and television advertising revenues —it works!  While the effectiveness of DTC advertising was interesting, the real eye opener was the authors’ historical account of the evolution of DTC advertising in the US. 

Although currently a hot topic, DTC advertising in the US has been around for nearly 300 years. In 1708, Nicholas Boone placed the first advertisement for a patent medication

in a Boston newspaper. For the next 230 years, advertisements for patented medications claiming to treat everything from dandruff to infidelity could be found in magazines, newspapers, and traveling medicine shows. In 1938, Congress passed the Food, Drug, and Cosmetic Act, which gave the FDA authority over the labeling of pharmaceuticals and the Federal Trade Commission control over their advertising.

No new legislation was introduced until 1962 when the Kefauver-Harris amendments proposed the concept of consumer protectionism when dealing with pharmaceuticals.

Under these amendments, authority for drug promotional advertising review was reassigned to the FDA. The FDA established requirements similar to those in existence today, i.e., specifications of contraindications, effectiveness, side effect profiles, and a cost-benefit discussion. Virtually all of the advertisements were targeted to physicians.

In 1981, the pharmaceutical industry proposed shifting marketing to include the consumer. At issue was the requirement to include extensive clinical information on the product, making it problematic to use television media to reach potential customers. That same year the Commissioner of the FDA, Arthur Hayes, requested the pharmaceutical industry put a voluntary moratorium on DTC advertising to allow the FDA to study their request to reduce the required disclaimers.

In 1985, the FDA concluded that the existing regulations to safeguard the public interest were adequate. This ruling had the effect of postponing the growth of DTC for the next 12 years. However, 1997 marked the beginning of rapid growth in DTC advertising. This change in marketing was attributed to the new FDA guidelines on broadcast DTC marketing. For the first time, drug manufacturers could present the name of the product and the condition it was intended to treat, and not report all of the contraindications.

The financial implications of this change in policy were enormous. In 1985, $17 million was spent on DTC marketing. By 2000, that figure rose to $2.5 billion, and $4.2 billion in 2005. In 2008, the estimated DTC marketing budget will be in the sum of $8 billion. Real spending on DTC advertising increased by 330% from 1996–2005.

As of 2007, only the US and New Zealand permit DTC advertising of prescription medications. In countries outside the US, the pharmaceutical industry has applied pressure to relax regulations regarding DTC marketing with little success. Despite DTC advertising being banned in most non-US countries, there is growing international concern that drug companies are circumventing legislation through the use of internet advertising and “spam” E-mail. Pharmaceutical companies also provide “awareness campaigns” or infomercials with vague references to prescription treatments in order to improve their sales abroad.

As previously mentioned on BioJobBlog, DTC advertising is big business. And, eliminating DTC advertising would likely help to reduce the cost associated with new drug development. This is because most drug makers don’t tell you that marketing and advertising costs are factored into the $1.0 billion that is generally believed to be the price associated with bringing a new drug to market. Who knew?

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Mark Senak who writes the EyeonFDA blog has compiled a list of the life sciences companies that presently have a Twitter account and use it. While there are only 12 companies on the list, he provides a nice commentary on their use and makes some recommendations for improvement.

Although I am a staunch supporter of the use of social media in the life sciences, it appears to me that the discussion about its use has been somewhat muted since the FDA convened a public hearing on the topic last month. I suspect that many of the companies and stakeholders who participated in the discussion prior to the FDA meeting are presently in “wait and see” mode. However, don’t be surprised if the social media guidance issued by FDA is lacking and excruciatingly wanting!!!! For those of you who may not be familiar with the ways in which the agency operates, its regulators tend to craft guidance and regulation that are broad, loosely defined and open to interpretation. The agency intentionally crafts its guidance and regulations this way because it doesn’t want its rules and regulations to be “literally interpreted” by companies and other stakeholders. Generally speaking, its regulations represent the “minimum” requirements that must be met in order to insure regulatory compliance. In other words, there is no upper limit on what companies can do to insure compliance but there certainly is a minimum requirement that must be met to avoid regulatory sanctions and penalties. As one lawyer who used to work for the agency shared with me recently, “FDA crafts the regulations but it is left to the companies and courts to interpret them.”

Most of the current discussions about social media and the life sciences industry primarily focus on its use as marketing and promotional vehicle. And, as many of you may already know, FDA isn’t exactly keen or pleased with the current marketing and advertising strategies and practices utilized by a sizeable number of life sciences companies. Perhaps a shift away from marketing and advertising discussions to more regulatory-friendly and practical applications like clinical trials recruitment and public outreach may lead to a more rapid uptake of social media by FDA and life sciences companies? Just sayin’

Until next time...

Good Luck and Good Tweeting!!!!

 

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In a previous blog post, I raised the possibility that the life sciences industry may be using adverse event (AE) reporting to explain why it has been slow to adopt social media as a means of communicating and interacting with its customers and stakeholders. The industry argument against social media goes something like this: by engaging physicians, consumers and other stakeholders in social media conversations, there will be a massive and unmanageable explosion of AEs posted to social networking sites, company websites and health and science blogs. Because of this, companies will be obliged to report them to FDA. Company executives’ fear that this will be inordinately expensive, egregiously time-consuming, technologically-daunting and most importantly, expose companies to possible legal and regulatory actions. While some of these claims may have some validity, they are not as expensive, technologically-challenging or insurmountable as anti-social media advocate would have you believe. For example, while conducting an interview for Life Science Leader magazine for an article on social media and pharma, several pharma employees exploring the social media space confided that most companies already have assiduously-crafted AE reporting policies in place to easily manage and accommodate AE reporting from  websites, cell phones and even text messages! For those of you who may be wondering, before potential AEs are required to be reported to FDA it must meet the following criteria: (i) there is an identifiable patient; (ii) there is an identifiable reporter or observer; (iii) there is a specific drug or biologic involved in the event; and (iv) there is an adverse event or fatal outcome.

Jonathan Richman (social media guru and pharmaceutical marketing expert) and I have previously weighed in on the so-called “adverse event reporting myth” that has been circulating in life sciences social media circles. In fact, I posited in my previous post that adverse event reporting may actually be something of a “red herring” being used by the industry. For those of you who may not be familiar with the term, it means focusing on an obvious and easily identifiable issue or object to draw attention away from a more important central issue.  To that end, I was pleased to read a post today on Jonathan’s Dose of Digital Blog entitled 166 Reportable Adverse Events Equals One Red Herring.

In today’s post, Jonathan does some basic mathematical calculations and arrives at the conclusion (based on the occurrence and frequency of Internet-based adverse events disclosed in a recent Nielsen survey) that the likely number of adverse events posted on social media sites per day would be around 166 (for the entire industry). Doing some of my own high-level mathematical calculations; this translates into a likely total annual number of about 60,590 AEs. And, as Jonathan rightly points out, if this number is divided by the number of life sciences companies with approved drugs and devices on the market, you quickly realize that shouldn’t be that onerous, labor intensive or expensive for companies to manage AE reporting resulting from social media sources. It would be interesting and informative to compare this annual rate with the actual number of reportable annual adverse events being handled by life sciences companies today. 

Like Jonathan, I believe that the “adverse event reporting issue” is a classic example of a “red herring” being employed by the life sciences industry to explain its reluctance to jump on the social media bandwagon. Personally, what I believe is really at stake, is the systemic changes that would be required to transform a historically, opaque and unresponsive industry into a transparent, accountable and responsive one that would be required if it embraces social media as an integral part of its business model.  

Addendum:  Shortly after posting this article, a new post appeared on the Dose of Digital blog that provided an indepth analysis of the Nielsen survey and its implications.

Until next time...

Good Luck and Good Job Hunting!!!!

 

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Mark Senak, social media advocate and author of the EyeonFDA blog, has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work!

As duly noted by Mark, FDA seems focused on inconsequential and banal issues like fair balance. The whole concept of fair balance has never been clearly defined and companies continually do everything possible to test the agency's resolve on the issue by finding new ways to push the envelope.Therefore, it makes no sense to me that the agency would choose to focus on the question of fair balance and social media when more pressing issues like adverse event reporting, responsibility for site content(when tools like Google Sidewiki are available to Internet users ) and off-label promotion of approved drugs and devices. As Mark rightly points out, is anybody really going to read the fine print about side effects and adverse events associated with a drug when they click through on an ad that promotes a medicine that might help them? Do people really read the product insert forms that accompany all prescription drugs?

Don't get me wrong. I am not trying to play down the importance of fair balance but DTC advertising is old hat and most experts agree that it really doesn't work well to sell prescription drugs. To that end, I think FDA needs to throw out the old play book and create a new one for social media. Unlike previous regulations, the ones that will guide social media need to be flexible and adaptive enough to accommodate the rapidly changing social media landscape. Nobody said it was going to be easy but that is why FDA employees get paid the big bucks!

Until next time....

Good luck and Happy Thanksgiving!!!!!!!!

 

 

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The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

 

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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

 

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Unlike many of my social media colleagues, I’m not attending the FDA public hearing taking place in Washington, D.C today (Friday the 13^th oh my). I wanted to attend and actually testify but I didn’t understand how the process works and blew my opportunity. However, I will be prepared for rounds 2 and 3 and beyond. I can assure you that this will not be the last public meeting organized by the agency to develop guidance for the use of social media in pharmaceutical marketing and advertising. 

The brouhaha over social media and its use in the life sciences industry is purportedly taking place because of the lack of regulatory guidance on the topic. While I agree that FDA needs to craft a reasonable regulatory policy for the use of social media for promotional purposes, the discussion taking place has little to do with the medium and everything to do with the fair balance of ads that are used to promote drug sales. For those of you who may not know, fair balance (in regulatory parlance) means that drug manufacturers are required to fully disclose in print, television, radio and internet ads the benefits as well as the side effects and risks associated with a specific product. Unfortunately, too often, drug makers tend to promote the therapeutic benefits of a drug but downplay its side effects and risks. This isn’t surprising because drug makers, like other for-profit companies, must sell as much product as possible to generate sufficient revenues to remain profitable.  And, as we all know, consumers and physicians are more likely to use or prescribe drugs that have therapeutic benefits without many side effects or risks.

Since the inception of direct-to-consumer advertising, FDA and drug makers have been playing a cat-and mouse-game with the fair balance issue. Most drug makers understand the “balance” that FDA requires for traditional promotional ads, but rather than abide by the rules, many choose to determine how far they can bend the rules before they appear on FDA’s radar. Therefore, it should come as no surprise that drug companies have adopted the same strategy when it comes to Internet advertising and search result ads. To be fair, FDA hasn’t crafted any definitive guidance on Internet advertising or search ad fair balance requirements. However, rather than apply what they have learned over the years about fair balance in print and television advertising, many drug makers chose to ignore fair balance requirements for Internet advertising simply because there are no written regulations or rules. To that end, 14 pharmaceutical and biotechnology companies recently received warning letters about their misuse of promotional drug ads that appeared with Google search results. FDA cited the lack of fair balance in the search ads as reasons for the warning letters. By issuing identical warning letters to 14 different drug companies, the agency was essentially saying “c’mon guys, who are you trying to kid—you ought to know better by now!”

Unfortunately, even when there are regulations, many companies spend hundreds of millions of dollars to look for deficiencies and loopholes that can be exploited to increase and improve drug sales. Therefore, I contend, that regardless of the social media guidance that FDA ultimately issues, drug and device manufacturers will continue to look for work arounds to regulations that they perceive hinder product sales.  

Social media is all about transparency, accessibility and communications between participants. The guidance that FDA issues about the use of social media in the life sciences industry will likely be circumspect and open to interpretation as it usually is. As one FDA legal expert explained to me, “FDA crafts the laws but it is up to the judiciary  to interpret how they ought to be applied.”

I suspect little will change until drug manufacturers realize that full disclosure and transparency, not half-truths and opaqueness, will ultimately lead to improved drug sales in the future.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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In today’s edition of the incisive EyeonFDA blog, Mark Senak, provides a historical perspective on events leading to the US Food and Drug Administration public hearing on the use of social media and medical promotion that will be held on Thursday and Friday, November 12 and 13, 2009. As Mark points out, registration for the meeting was closed because of an overwhelming response and the number of people who wanted to offer testimony on the topic. Many social media enthusiasts view the public hearing as something of a “game changer” that may influence the future direction of social media in the life sciences industry. But, as Mark, astutely points out, only four pharmaceutical companies and one or two trade organizations will be participating at the hearing. 

The lack of industry participation at the meeting is curious given that 14 companies received warning letters several months ago about their misuse of ad associated with the results obtain by Google search. Further, pharmaceutical companies have consistently and publicly stated that their aversion to social media is contingent upon the lack of FDA’s regulatory guidance for its use. By not actively participating in the public hearings later this week, many pharma companies have chosen to remain silent and will likely allow FDA to craft social media policies that guide the promotional activities of drug makers on its own. This begs the question: why would drug makers allow a federal regulatory agency to unilaterally dictate policy, when the policy will likely affect their bottom lines, i.e. sales and profits? The industry’s refusal to actively participate in these hearings is another example of the cat and mouse game that drug makers like to play with FDA. Put simply, drug makers expect and want FDA to commit (in writing) to certain policies and guidelines and once established, company regulators and lawyers are instructed to find loopholes and work-arounds. I liken the drug industry’s refusal to actively participate in the upcoming public hearings to the now infamous rope-ad-dope strategy Mohammed Ali used to knock out George Foreman in the now infamous Rumble in the Jungle in 1974. This is how wikipedia defines the rope-a-dope: “The rope-a-dope is performed by a boxer assuming a protected stance, in Ali's classic pose, lying against the ropes, and allowing his opponent to hit him, in the hope that the opponent will become tired and make mistakes which the boxer can exploit in a counterattack.” I hope that I am wrong about the drug industry’s strategy and motives.

Without active industry participation it isn’t clear how effective the FDA public hearing on social media will be. As Mark adroitly points out in today’s post, “The bulk of the other presentations are tertiary stakeholders perhaps sensing a vehicle for free self-promotion such as advertising and public relations firms and bloggers, but they aren't the real stakeholders in this issue.  The real stakeholders are those who are referred to in the meeting notice - the medical products industry.” I would also add the American public to the stakeholder list who also has considerable “skin in the game.”

Pharma’s active participation at many of the social media conferences that I recently attended indicates that something must be in it for pharma; otherwise they wouldn’t attend. There is no question that social media isn’t a passing fad and is now an integral part of the Web 2.0 experience. That said, for the first time in many years, drug makers have a unique opportunity to actively voice their ideas and concerns and collaboratively work with FDA to craft meaningful social media regulatory guidance. As many of us “outside observers” know, the agency doesn’t have all the answers and we would like to think that drug makers would extend a helping hand to avoid confusion and misunderstandings about the use of social media to promote their products and services. While only 4 companies are scheduled to speak at the hearings, I suspect that there will be many life science company representatives in attendance. Nevertheless, despite what may happen at this week’s hearings, I hope that, going forward, drug makers and device manufacturers will begin to view FDA as a partner rather than an adversary!

Until next time...

Good Luck and Good Job Hunting!!!!

 

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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

 

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e-Patients Connections 2009 (#epatcon) was held this past Monday and Tuesday at the Park Hyatt hotel in Philadelphia, PA. BioCrowd was one of several co-sponsors of the event. The theme of the conference, organized by Kevin Kruse a veteran medical communication and training expert, who now runs Kru Research, was to “reach, engage and educate empowered digital health consumers.” And, boy, did it deliver! While this was Kru Research’s first official conference, it was well organized, extremely interactive and the quality of the speakers was second to none! Topics that were featured included social media and the life sciences industry, technological advances in e-based healthcare delivery, the relationship between the news media and healthcare information and the continuing evolution of online and e-based healthcare communities.

Conference attendees included representatives from the life sciences industry, medical communications experts, advertising and marketing professionals and a multitude of social media enthusiasts and consultants who kept the Twitter screen humming throughout the meeting (a big shout out to the “troublemaking table”). And, surprisingly, there was a representative from the Division of Drug Marketing and Advertising and Communications (DDMAC) at the US Food and Drug Administration, who I believe, was one of the most sought after individuals at the meeting. CNN reporter Elizabeth Cohen who writes the Empowered Patient and racecar driver Charles Kimball, a type I diabetic and company spokesperson for Novo Nordisk also gave talks.

My favorite talks were those presented by online patient community organizers including Tricia Geoghegan of Ortho-McNeil-Janssen Pharmaceuticals who created the Facebook ADHD Allies community, Lisa Tate of WomenHeart and Robert Schumm of Bayer Consumer Care who created Facebook Strong@ Heart and Rachel Lewinson of the Juvenile Diabetes Research Organization and Susan Harrow Rago of Novo Nordisk who created Juvenation.org a website dedicated to those with Type I diabetes. These communities are outstanding examples of how partnerships between pharmaceutical companies and advocacy groups can help to better educate the public and heighten awareness about potentially life-altering diseases. Another example of a great online community and healthcare portal is Insomnia 123.com. This website was conceived and constructed by Christine Macadams and her partners’ one of whom is a practicing physician. Unlike the other online communities, which are sponsored and mainly supported by consumer healthcare division of large pharmaceutical companies, Insomnia 123.com was exclusively created by a group of concerned individuals who wanted to better educate and improve the lives of people with insomnia—a largely unreported and self-medicated condition.

On the technical side, the talks presented by Lee Segal of Klick, Kevin Durr of Avantera , Ian Kelly of Red Nucleus and Scott Ballenger of ListenLogic were illuminating and extremely informative. Some of the innovations taking place in digital media are exciting and almost overwhelming at times (even for a social media enthusiast like me). I think the company to watch is ListenLogic which uses semantic search engines to collect real time data and “chatter” on the web. This technology may provide a cost-effective solution to assuage the concerns of many life sciences companies that claim that collecting and analyzing overwhelming amounts of data is one of the main reasons why they are reluctant to entry the social media space.

Marc Monseau of Johnson and Johnson gave an illuminating talk on his experiences as a corporate blogger and Twitter user and described some of the challenges that had to be overcome before his company was able to break the “social media barrier.” Janice McCallum, an economist by training and a healthcare communications and media expert gave an informative talk about the growing role and impact of patient-generated healthcare content on patient awareness and education.

Finally, the novel and innovative Pecha Kucha sessions were outstanding and extremely well done! While all were expertly crafted, Dr. Val’s and Jonathan Richman’s Pecha Kucha were memorable. Dr. Val’s, which was extremely powerful and moving, was performed entirely in verse and Jonathan’s was—well, one of Jonathan’s always entertaining and informative presentations.

In summary, the “e-Patient Connections 2009” was a resounding success and in my opinion reached its goal to “reach engage and educate empowered digital health consumers.” That said, I can’t wait for “e-Patient Connections 2010” meeting!!!

Hat tip to @ellenhoenig and @eileenobrien for inviting me to my first tweetup (great fun) and finally meeting @janice McCallum, @christianeTrue, @stevewoodruff and Silja aka @whydotpharma! 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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Late last week, the US Food and Drug Administration (FDA) approved GlaxoSmithKline’s cervical cancer vaccine Cervarix for use in girls and women ages 10 to 25 and also approved Gardasil —Merck’s cervical cancer vaccine previously approved in 2006 for use in girls and women—for boys and men ages 9 to 26. For those of you who may not know, over 99% of human cervical cancers are caused by infections with cancer-causing strains of the human papilloma virus (HPV) which also causes venereal warts. Vaccination with Cervarix protects against cervical cancer by inducing immunity against HPV 16 and 18 (which cause most cervical cancers in developed nations) whereas Gardasil affords protection against HPV 16 and 18 as well as HPV 6 and 11, strains that cause venereal warts (which don’t lead to cancer).

Despite FDA’s approval to vaccinate boys with Gardasil to prevent HPV infections, the Centers for Disease Control’s Advisory Committee on Immunization Practices (ACIP)— which guides national policy on use of vaccines—decided yesterday to recommend the use of the vaccine in girls and women but didn’t fully endorse its use in males. Typically, ACIP recommendations are adopted by professional medical associations and set the standards of practice for physicians. Also, its recommendations play a major role in determining whether or not insurers and third party payors will reimburse patients who are vaccinated. The new recommendations mean, in effect, that physicians and clinics may now administer the vaccine at their discretion to boys and men ages 9 to 26, but they are not expected to offer it. In contrast, vaccination of girls and women ages 10 to 25 will be strongly recommended, readily available and reimbursable. This means that parents may consider the vaccine as an option for their sons, but some health insurers may choose not to cover the shots—an option which is sure to severely limit the numbers of boys and men who are vaccinated with Gardasil.

The ACIP committee decided not to include Gardasil immunization for boys and men on its recommended list because several members, most notably a medical economist, questioned whether vaccinating boys would be cost effective in the long run. At the heart of the debate was whether or not it was appropriate and cost-effective to vaccinate boys for a problem (venereal warts) that can be embarrassing and uncomfortable but is not life-threatening. For those of you who may not know, Gardasil immunization is expensive and requires a series of three injections that cost $130 each ($390 total).  Cervarix, which also requires a series of three injections, is planned to be offered for $385.

Last year in the United States, about 37 percent of girls ages 13 to 17 started the Gardasil vaccine series, a national immunization survey showed, and about half of them completed it. Not a great track record for a vaccine demonstrated to prevent cervical cancer and dramatically reduce the transmission of venereal warts. Nevertheless, yesterday’s decision to recommend vaccination for girls and women but not boys and men makes no sense to me from a public health perspective and it almost smacks of gender bias. Let me explain.

Like all other sexually transmitted diseases (STDs), HPV is transmitted from men to women and visa versa. Based on years of epidemiological studies, the only effective way to reduce the overall incidence of STDs is to implement strategies that prevent infections in both females and males. While boys and men can’t develop cervical cancer, they do contract venereal warts and perhaps, more importantly, can serve as carriers or reservoirs of HPV infection in the population. In other words, infected males (who may or may not show symptoms of HPV infection) still possess the potential to transmit it to sexually-active, unvaccinated girls and women. Consequently, while the incidence of HPV infections may begin to decrease among women after immunization, it will never be completely eliminated and the possibility of developing cervical cancer will continue to be a public health concern.

While the ACIP’s understanding of the transmission of STDs is tragically flawed, its willingness to publicly disclose cost effectiveness as a reason to not endorse HPV vaccination for males is even more egregious! The agency’s decision begs the question: Which is more costly; 10,000 American women developing cervical cancer each year (and countless others going for unnecessary cervical biopsies because of “bad” Pap smears) or a heads up to insurance companies that they ought to cover the costs of male HPV immunizations? 

The ACIP’s reluctance to recommend male HPV vaccination based on economic and health care cost concerns rather than on public health implications is yet another example of how broken the US healthcare system is and how drastically it needs to be reformed. Allowing 3,700 women to die each year in the US from cervical cancer when there is a safe and effective way to prevent these deaths is, in my opinion, unconscionable!

Until next time...

Good Luck and Good Job Hunting!!!!!

 

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Without fanfare, GlaxoSmithKline (GSK) quietly announced today that the US Food and Drug Administration (FDA) granted approval for CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

It has taken GSK over three years to garner US regulatory approval for CERVARIX® which has been approved and used in over 100 other countries in the world. Early "unspecified concerns" delayed approval and, as recently as two weeks, FDA delayed a decision despite recommendations from an advisory panel to approve the vaccine. Coincidentally, a week before the agency was expected to announce approval for the vaccine, a British girl died after she was vaccinated with Cervarix. While FDA spokespersons claimed that the girl’s death following vaccination had nothing to do with the delaying a decision on Cervarix, many industry pundits believe that the FDA was reluctant to approve the vaccine in light of the sensational media coverage in the UK surrounding the incident. After an autopsy was performed on the girl, British authorities announced that a massive cardiac tumor that had infiltrated one of her lungs, not Cervarix was responsible for her death.

Today’s approval of Cervarix provides American consumers with an alterative to Gardasil, Merck’s cervical cancer vaccine that was approved about two years ago. That said, the ability to protect girls and young women from the possibility of developing cervical cancer is more important than which of the two vaccines is used to induce immunity. I plan on immunizing my daughter when she is old enough!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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The answer to this question is not yet! However, the The Wall Street Journal recently reported that 64% of U.S. physicians are using smart phones (up 50% from two years ago) and increasingly are relying on them to find medical information, manage patients and transmitting clinical data. To that end, a post at the Medical Translation Insights blog discusses the changing role of smart phones in healthcare and the regulatory challenges they may face if classified as medical devices.

 When Cell Phones Become Medical Devices

The definition of "medical device" is shifting, quickly and dramatically.  The revised MDD now includes stand-alone software in the definition. In other words,if software has a medical purpose, it probably can/must be CE marked. And smart phones are quickly becoming the conduit of choice for collecting and researching, disseminating, and evaluating clinical data.

As Bob on Medical Device Software points out, its unique user interface, display, and broadband capabilities make the Apple iPhone a particularly attractive platform for medical applications. For example, the AirStrip OBSERVER suite of applications is custom-designed for the iPhone, makes some components available for download at the Apple App Store, and received FDA clearance for some modalities.

While most medical apps fall into the reference category, applications are getting more sophisticated and are taking advantage of the devices networking abilities. A trio of applications developed by researchers at the University of Utah aptly demonstrate these advances. Another factor is the appeal and widespread use of these devices. The Wall Street Journal reports [login required] today that 64% of U.S. physicians are using smart phones.

There are several big questions and unknowns hanging over these developments: First and foremost, there is the question of data security. As quoted in the same WSJ article, Deborah Peel of Patient Privacy Rights worries that "the vast majority of health information technology has not been designed to ensure that patients control access to that data and use of that data". So, paradoxically, the more ways that doctors can access patients' records, the more their confidentiality is threatened.

Second, what is the quality threshold for smart phone applications? Just because something is on the iPhone doesn't mean it's necessarily a quality application

Regulators around the world are bound to tackle these questions. FDA, for instance, is already looking at this issue and sooner or later will regulate certain phones. It's certainly not the end of the world to be classified as a medical device, but verification and validation of these applications won't be easy.

 As these applications get developed and become part of a networked medical device, language will also become an issue again. Translation service providers will need to become familiar with smart phone development and localization issues and support consistently translated content across multiple platforms and media.

Until next time...

Good Luck and Good Job Hunting

ForeignExchange Translations provides specialized language services to pharmaceutical and medical device companies

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I came across a recent post on Adage.com entitled “Pharma Drops Search Advertising After FDA Warning” that revealed that paid search ads by pharmaceutical companies dropped a 84% between March 26 of this year and the end of June. As you may recall, March 26 was when 14 companies received warning letters from the US Food and Drug Administration (FDA) indicating that they had violated marketing guidelines for search ad advertising. The letters stated that sponsored-link advertisements for specific drugs were misleading due to the exclusion of risk information associated with the use of the drug -- even though the regulatory agency's guidelines are for print and broadcast, not online or social media. Pharma companies that believed they were in compliance with the unwritten "one-click rule"— taking the consumer from the ad to a site that offered fair balance and the risk information by clicking on the ad. What? Did I read that correctly; the words “unwritten and FDA” in the same sentence? This is very surprising since anybody who has worked with the agency is well aware of the “if it isn’t written it didn’t happen” principle. But I digress....

The post went on to say that pharmaceutical companies are “fearful of running afoul” of the agency again. Say what? The words “pharma and fearful” used in the same sentence? The point that I am trying to make is that pharma chose to keep things vague about web-based advertising to see how far they can push the envelope with FDA instead of taking the proverbial “bull by the horns” and directly asking FDA for guidance on web 2.0 technologies and their uses. Wouldn’t it be in everyone’s best interest if companies took a more active role to help craft new rules on the use of new media technologies rather then rely on and wait for FDA to do it for them? While the old “cat and mouse” game worked for old media, it is no longer tenable when it comes to Web 2.0 and related technologies.

The FDA is holding public hearings next month to begin the process of establishing internet advertising guidelines and the use of social media in the life science industry. This offers drug and devices companies an opportunity to show FDA that they no longer want to be part of the problem but part of the solution.  I have always subscribed to the notion that “you don’t get if you don’t ask!”

Until next time...

Good Luck and Good Surfing (on the Internet that is)

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The bad news is that the US unemployment rate is close to 10 percent. The good news is that the government is looking for scientists at FDA, NIH, USDA, CDC, EPA and other agencies. For those of you who haven’t applied for a government job, the process can be daunting and overwhelming. To alleviate some of the pain, Cyndi Fischer, MSA at the BioCareer Center has written a post on the salient features of filling out a job application for a government job!

Capturing Your Worth in a Government Job Application 

You’d like to consider government employment but are not sure where to start. You know the government has a generous compensation and benefit plan, can offer long term employment stability, and in most cases its employees do not need to seek research grants or funding to continue their rewarding scientific work. Sounds like a dream, so why haven’t you applied? Perhaps you’ve heard that it’s hard to get a government job, that the hiring process is mysterious, slow and a confusing maze of information. While some of those concerns are valid some of the time, government employment has such positive benefits it is indeed a career path you don’t want to overlook. The most important thing to remember about applying for a government position is that all the items that appear to be drawbacks to you in the application phase, are really set in place to ensure that the most qualified candidate, hopefully you, will get the job!

So what do you need to know to ensure that you have the best shot at being considered for a coveted research position within the government? First you must apply to a vacancy announcement published by the government in order to be considered, and subsequently offered employment. Almost all government entities now use an automated system to post vacancy announcements and receive applications. The most widely used website to post vacancy announcements is USAJOBS.opm.gov. Once you have established an account on the site and placed your resume in the space available, you are ready to apply for any vacancy announcement you would like. Be keenly aware though, this is where attention to detail separates the candidates to be interviewed from the resumes in the scrap pile. The government hiring system revolves around merit. Specifically, the candidate who has the most knowledge, skills and abilities (KSA) to be successful in the vacant position should be offered the job, as the desired KSA’s for an opening are derived from the position description itself. Your role is to ensure that you capture your KSA’s as accurately as possible so that you are considered for the positions you are most qualified to hold.

If KSA’s are the key to government employment, how do you ensure you include everything that needs to be considered? In many cases this will be easy to discern as the vacancy announcement will list specific KSA questions prompting your response. If there are questions that seek specific answers, it is a requirement that you answer them or your application will not even be considered. In the event there are not specific questions presented, you must ensure you cover the likely KSA’s for that position within the body of your resume. Knowing what the KSA’s are for the position being advertised is one

aspect of being qualified for the position you are seeking. Let’s take a quick look at each element of the KSA’s so you know how to present your talents.

Knowledge covers the body of intellectual information you possess that will assist you in the position. This knowledge is not limited to your academic knowledge, though critical, but encompasses all aspects of what you know that pertain to the position. Included in your mental reference library are federal, state and local regulations that govern the work you will be doing, policies and procedures that apply to the work environment, industry standards and cutting edge technology that you are current in that would make you a good fit for the position. Essentially any knowledge that you possess and can articulate in your resume that is pertinent to the job you are seeking is something you should capture in your resume or the KSA questions presented as part of the announcement.

Skills represent the manipulation of systems, processes, people and things that will allow you to be competent in the position in question. They can include specific skills that require you to operate technical equipment or work with particular software or hardware systems or they may be more generic such as the skills required to communicate effectively. These skills are often the core competencies of the position and are incredibility important. Conversely, some of them are areas that professionals often under-report in their resumes as they take many of these skills for granted such as problem solving, creative thinking, decision making and stress tolerance. In most cases, government application software systems allow you a very generous amount of character space to document your KSA’s or resume, so leave no skill uncaptured!

Abilities refer to your capabilities as they apply to the work environment. Your ability to manage people and programs; to organize, plan, implement, and evaluate; to analyze, supervise or otherwise effectively impact the mission of the organization. One of the unique aspects of this element is that you do not have to have a vast work history to quantify what you can offer an employer in this category. You may have organized a large volunteer effort or been part of a regional political campaign. Any quantifiable information that depicts your role in a challenging environment which allows you to capture the results of your efforts is value added in this element.

Government employment has many rewarding aspects – not the least of which is that the infrastructure of the whole civil service is based on merit. Now that you know a little more about how to present yourself and what you have to offer in the three key government consideration areas (KSA’s) you are one step closer to accepting your first federal research position. Remember it’s not what you know and what you can do that counts in a job application; it’s what the selecting official knows you can do that matters. Good luck!

Cyndi Fischer, MSA is the Director of Strategic Recruitment for STG International. As a Human Capital Management specialist her work concentrates on agency level recruitment strategies and workforce planning. During her tenure at STG, Mrs. Fischer has designed and implemented recruitment strategies, branding techniques, and succession plans for many federal agencies seeking Phd/MD level candidates for research, managerial, and professional opportunities. Mrs. Fischer has a Bachelor of Science degree in Criminal Justice and Psychology and a Master of Science in Administration degree in Human Resources. www.stginternational.com

 

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My son, who is a 9^th grader, was recently asked to write an essay for his social studies class about the application of Machiavellian principles to modern day rulers and governments. One of Machiavelli’s ideas that he chose to write about was the notion that a good ruler or government must do it’s very best to insure the safety and health of its subjects or constituents. While this may seem altruistic or philanthropic don’t be fooled—workers who are afraid, unhealthy or regularly ill aren’t productive and can threaten the economic well-being and stability of a society. In any event, he asked me to help with a modern day example of how safety can be reconciled with the Machiavellian principle; “the end justifies the means.” As an infectious disease professional, I quickly realized that mandatory vaccination of newborns and school-aged children against viral and bacterial diseases is a great example.

Prior to the development and subsequent worldwide use of childhood vaccines, epidemics and pandemics of smallpox, measles, polio, diphtheria and other serious diseases routinely ravaged the planet with impunity. During the recurring outbreaks, large numbers of people became ill, and while some sustained life-long debilitating injuries, many others suffered long, painful and excruciating deaths. The recognition that often devastating and regularly occurring outbreaks and epidemics could threaten the well being— and possibly destabilize monarchies and democratically elected governments—  led to the development of  20^th century vaccines against many bacterial and viral childhood diseases. However, it is important to note, while most vaccines are safe and offer protection for many individuals (typically 90% or higher), a small percentage (usually 1% to 5%) of those vaccinated, may experience side effects ranging from mild to severe and possibly life threatening. I believe that vaccination is a polemic for the “ends justify the means” principle because while some vaccinated individual may suffer serious side effects or death greater numbers will benefit from the protection and safety afforded by most vaccines. In other words, governments must be willing to risk harm and possibly death to some of its citizens to insure the productivity, well being and ultimately the safety of the majority.

Despite the medical and health benefits of vaccines, the anti-vaccine movement in the US has steadily been gaining strength of late. Vaccine opponents’ fears have been stoked and promulgated by bogus clinical data offered by fraudulent scientists (which have subsequently been discredited and refuted) and media outlets seeking sensational stories to sell magazines and newspapers. Last week, a 14 year old British girl died shortly after being vaccinated with Cervarix, GlaxoSmithKline’s (GSK) cervical cancer vaccine. This story was quickly pounced upon by the British tabloids and widely circulated.  In the end, the safety of the Cervarix—a vaccine administered to 1.8 million girls without a single death similar to the one that had occurred—became suspect. Almost immediately, anti-vaccine advocates publicized this unfortunate incident as another other reason why parents shouldn’t vaccinate their children. The girl’s death prompted UK officials to immediately suspend all nationwide Cervarix vaccinations; even though an autopsy hadn’t been performed to determine the actual cause of the girl’s death. After an autopsy was finally performed, British health officials announced that the girl had a large cardiac tumor that had infiltrated one of her lungs and that it was likely cancer not Cervarix that caused her death. Unfortunately, the media’s feeding frenzy fanned by the anti-vaccine lobby’s loud voice may have cost GSK US FDA approval of  Cervarix—a product approved and safely used in over 100 countries! 

About three weeks prior to the British girl’s death, an FDA advisory committee unanimously recommended approval of Cervarix. Generally, the agency follows recommendations of its advisory committees. Ironically, the girl’s death occurred several day’s prior to an FDA decision on whether or not to approve Cervarix. Much to the surprise of many industry experts, this past Tuesday, FDA delayed its decision on Cervarix’s approval. FDA spokespeople claimed that the girl’s death had no bearing on its decision to delay Cervarix’s approval (if you believe that, would any of you be interested in some land in Florida?).

It is no secret that GSK has struggled to get Cervarix approved in the US —a decision on its approval has been delayed three times over the past several years. In the interim, the company has managed to successfully address all of the agency’s concerns over Cervarix’s safety and efficacy.

FDA’s decision to delay Cervarix’s approval is great news and something of a victory for Merck, the manufacturer of Gardasil— the ONLY cervical cancer vaccine approved in the US and Cervarix’s main competitor. Failure of Cervarix to win FDA approval will undoubtedly help Merck to bolster Gardasil sales and help it maintain its stranglehold on the US anti-cervical cancer market for the foreseeable future!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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Allergan, the maker of Botox and Latisse sued the US Food and Drug Administration (FDA) in federal court yesterday because it believes that regulations banning off label promotion of prescription drugs violates the company’s right to freedom of speech and impedes its ability to provide physicians with information regarding patient safety.

The company contends in a lawsuit filed Thursday that it should be able to educate doctors about the risks and benefits of using treatments for unapproved uses. Botox is approved for several uses by the Food and Drug Administration. In addition to its use as a wrinkle treatment, it is approved for eye muscle disorders and excessive underarm sweating. But physicians often use it for unapproved, or off-label, indications including muscle-spasm conditions.

The impetus for the lawsuit is an FDA requirement that the company provide new risk information education to physicians on Botox as a therapeutic treatment. According to an Allergan spokesperson, "Our reason for seeking action now relates to the fact that we have recently been required by FDA to initiate a REMS (Risk and Mitigation) program for Botox to ensure that physicians are equipped to evaluate the risks and benefits of treatment." In April, health officials warned doctors and patients about potentially deadly risks of using Botox and similar drugs for unapproved uses to treat certain types of muscle spasms. The drugs carried risks of rare botulism symptoms, particularly when given to children to help relax uncontrollable muscle movements.

Allergan estimates that 20% of Botox usage is off-label for unapproved indications. Because of this, the company believes that it is important to “proactively provide comprehensive information to physicians about these off-label uses, such as dosing guidelines, patient selection criteria and proper injection technique to ensure that physicians are equipped to treat patients as safely and successfully as possible. And, “without judicial relief, Allergan is unable to engage in a truthful and relevant information exchange with the medical community for fear of prosecution." 

It sounds to me like the lawsuit is more about increasing the annual sales of Botox for a growing number of unapproved indications rather than ensuring patient safety. These types of lawsuits have becoming increasingly popular because of previous legal precedent that extends an individual’s right to freedom of speech to corporations and other entities. However, more importantly, if Allergan is successful, it could signal the end of the regulations and ban on off label promotion of prescription drugs and devices. Is eliminating a few wrinkles from aging baby boomers (like me) worth all the trouble?

Until next time...

Good Luck and Good Job Hunting (hmm...maybe if I look younger I might be able to find a job?)

 

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The New York Times that W. Scott Harkonen, MD the former chief executive of InterMune, a Brisbane, CA biopharmaceutical company, was convicted yesterday for issuing what federal prosecutors called a misleading press release that contributed to off-label sales of the company’s drug Actimmune.

Actimmune is bioengineered form of interferon gamma approved in 2000 to treat children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis—two relatively rare genetic diseases. But the main sales of the drug, which peaked at $141million in 2003, came from an unapproved use: treating idiopathic pulmonary fibrosis, a scarring of the lungs that can be fatal. While licensed physicians in the US can prescribe approved drugs for off label, it is illegal for drug makers to promote the use of prescription drugs to treat indications for which the drug didn’t receive approval.

According to the Times article, InterMune conducted a large clinical trial testing Actimmune as a treatment for the lung disease. The drug did not achieve the clinical endpoints of the trial, which was to improve lung function of patients receiving Actimmune as compared with patients receiving a placebo. However, a review of the statistical analyses of the trial revealed that if only the patients in the trial with mild or moderate disease were considered, those who got the drug lived longer than those who received the placebo .The company highlighted the “survival benefit” of patients treated with Actimmune in a news release, issued in August 2002.  Following the press release, sales of Actimmune (which costs about $50,000 per year) peak at $141 million in 2003—the drug was mainly being used to treat idiopathic pulmonary fibrosis an indication for which the drug hadn’t received regulatory approval. Because of this, federal prosecutors contended that the news release was part of a scheme to induce off-label sales of Actimmune. Interestingly, in 2007, a second large clinical trial of Actimmune found that the drug didn’t prolong the lives of patients with pulmonary fibrosis.

The InterMune case isn’t unique in the life sciences industry. Time and time again companies are charged with off-label promotional activities and typically these cases are settled before they go to trial. To that end, the InterMune case is an exception but Harkonen’s conviction sends a warn drug company executives that the US government takes off label promotion seriously and it will no longer be tolerated.

While it can be argued that off label drug use can benefit patients and ought to be allowed, off label promotion of previously approved drugs allows drug companies to benefit financially without investing in expensive clinical trials to win regulatory approval for the off label indication. In other words, off label promotion of prescription drugs can be a financial windfall for companies and induce them to place profits ahead of patient safety and drug efficacy. This is why promotion of off label use of prescription drugs is illegal and a prosecutable crime. 

It is important to remember that prescription drugs are required to undergo a rigorous regulatory review to insure that they are safe and efficacious. While the use of approved drugs to treat off label indications may benefit some patients, the drugs in question must be rigorously tested for safety and efficacy to treat the indication before they are used to in large numbers of patients. And, as we have seen in recent years, even drugs that have gone through clinical testing and garnered regulatory approval may not be as effective or safe when used to treat billions of patients!

Until next time...

Good Luck and Good Job Hunting!!!!!!!

 

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A spokesperson at the US Food and Drug Administration (FDA) announced today that it decided to delay its decision whether or not to approve GlaxoSmithKline’s (GSK) anti-cervical cancer vaccine Cervarix. The agency was scheduled to announce its ruling Tuesday on whether to approve Cervarix, but a GSK spokeswoman said the review will continue. An agency spokesperson failed to disclose any reasons for the delay because FDA doesn’t comment on ongoing product reviews. This is the second regulatory delay for Cervarix in the past two years.

The delay comes as something of a surprise because earlier this Earlier this month, an outside panel of health experts voted that Cervarix appears safe and effective for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does. Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007, when the FDA said it needed additional safety data.

An approval from FDA would allow London-based GSK to compete against Merck's blockbuster vaccine Gardasil, which has been on the US market following its approval in 2006. Based on all available published reports, Cervarix has a similar safety profile and efficacy profile as compared with Gardasil.

One of the issues with Cervarix may be the adjuvant use to formulate the vaccine to bolster anti-HPV immunity. While Merck's Gardasil uses an aluminum salt adjuvant, Cervarix uses a novel adjuvant known as AS04. The agency’s lack of familiarity with AS04 and possible concerns about its safety may be what is delaying the Cervarix decision. 

Stay tuned for further details!

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Mark Senak at the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) is seeking public input on the use of social media in the pharmaceutical, biotechnology and medical devices/diagnostic industry. Meetings to solicit input will be held in Washington DC on November 12 and 13^th.  This will be the first opportunity for industry representatives and the public to begin a discussion with FDA on the policies that will guide the use of social media in the life sciences industry.

According to EyeonFDA, on Monday, the agency will publish a notice in the Federal Register announcing this historic event (see excerpt below)

Questions have arisen regarding the application of the prescription drug and device advertising and labeling provisions, regulations, and policies of promotion on the Internet, especially with regard to the use of emerging technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis. This section briefly discusses the issues the agency has identified as most frequently raised by regulated companies and other interested parties. It should be noted that although a question may raise a particular issue, that does not necessarily mean that the agency will issue guidance or a regulation on that issue. The agency invites comment at the public hearing on the general concept of Internet promotion, positive or negative; on any aspect of Internet promotion that is of interest to the presenter; and on the topics outlined in the following paragraphs. We are specifically interested in data and research on the use of social media tools in promotion, including data from companies on their own experiences, the extent to which health care professionals and consumers are using and are influenced by various social media tools, and the impact of Internet and social media promotion on the public health.

For the past year or more, many bloggers and other social media enthusiasts have taken FDA to task for not taking action on the topic. Finally, the agency realized that something had to be done given the growing use and popularity of social media tools and strategies in other less regulated industries. Earlier this week, in an unexpected move, FDA launched its first Twitter feed. Perhaps this was a hint that FDA is beginning to emerge from the dark ages into the digital world of Web 2.0 and social media.

Hat tip to Mark!

Until next time...

Good Luck and Good Twittering !!!!!!!

 

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Mark Senak who runs the EyeonFDA blog reported yesterday that the US Food and Drug Administration (FDA) had launched a Twitter account. As Mark aptly points out, FDA’s unexpected leap into social media is ironic given that the agency has been steadfastly reluctant to craft any guidance whatsoever on the use of Web 2.0  technology or social media by drug and device manufacturers. Maybe, the agency was tired of being overshadowed by the Centers for Disease Control in Atlanta, GA whose rapid adoption and use of social media for public health and related issues has been outstanding. 

For those of you FDA aficionados, FDA can be found on Twitter at @FDA_Drug_Info. Despite its very recent launch, the agency already has over 1,700 followers. Not surprisingly, FDA_Drug_Info is following only six individuals and is largely a one-way informational channel. Maybe somebody ought to tell the agency that social media, most notably Twitter, is suppose to be interactive and conversational? Also, couldn’t FDA staffers come up with a better Twitter handle? I mean the use of underlines to separate words in FDA_Drug_Info is so ......Web 1.0!!!! Finally, most of the information tweeted by the agency has to do with drug approvals, workshop announcements, safety warnings, etc. Maybe somebody also should tell them that most life sciences companies block Twitter and other forms of social media. Nevertheless, based on some recent tweets, it appears that the agency is targeting healthcare providers and consumers as their main audiences.

Despite FDA’s Twitter presence, I wouldn’t expect any Web 2.0 guidance or a drug and device social media policy any time soon. I say this because the agency yet to craft guidance on website design and Google Ads—two very ancient internet tools!!!! Maybe they ought to appoint a social media czar at the agency?

Until next time....

Good Luck and Good Tweeting!!!!

 

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The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of Cervarix®, GlaxoSmithKline (GSK) cervical cancer vaccine.

In a press release, the company announced that “Cervarix was shown to be highly effective and well tolerated in girls and young women for the prevention of cervical pre-cancers and cervical cancer related to human papillomavirus (HPV) types 16 and 18, the two most common virus types that cause cervical cancer. The committee also discussed data demonstrating the efficacy of  Cervarix against additional cancer-causing virus types.”

The Committee’s favorable recommendation, although not binding, will be considered by the FDA in its final review of the Biologics License Application (BLA) for the candidate vaccine.

In March 2009, GSK submitted final data from its Phase III pivotal study (HPV-008), the single largest efficacy trial of a cervical cancer vaccine to date. The file included data from clinical trials in more than 30 countries involving nearly 30,000 participants receiving Cervarix, which reflect an ethnically and racially diverse population and a broad range of women. It also included a thorough safety assessment relevant to 10-25 year old girls and young women.

Cervarix® has been approved in nearly 100 countries around the world, including the 27 member states of the European Union (EU), Australia, Brazil, South Korea, Mexico and Taiwan. Licensing applications have been submitted in more than 20 additional countries, including Japan and the United States. GSK also received World Health Organization (WHO) prequalification in July 2009.

The likely approval will provide girls and women with an alternative to Merck’s cervical cancer vaccine Gardasil which has been on the market for almost two years. Gardasil has recently come under fire by religious and anti-vaccine groups and sales have been lackluster lately. It will be interesting what effect if any Cervarix will have on the US anti-HPV/cervical cancer market. That said, I doubt whether Merck executives will be sleeping as well as they have been prior to today’s advisory panel recommendation!

For a great comparison of the two vaccines check out an article in today's New York Time business section.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!

 

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There was another article in today’s New York Times lamenting the marketing practices utilized by drug companies to inform physicians about their products. While these practices may be troubling to legislators and the American public, everybody who works in the life sciences industry including regulatory agencies like the US Food and Drug Administration (FDA) understands the “rules of the game” and how it is played. However,

over the past three years, there has been a full frontal assault on direct-to-consumer advertising and marketing and sales practices used by drug makers to hawk their products to physicians and the American public. This has largely been an over reaction to the lack of regulatory oversight of drug manufacturers during the Bush administration. The new regulations have severely limited what sales representatives can offer physicians e.g. gifts and free lunches and dinners, for more face time to sell their products. Consequently, the only means left available to drug makers to reach large numbers of physicians is marketing through medical education.

This is how it works. Companies annually budget monies to pay highly recognized physicians aka key opinion leaders (KOLs) to give lectures to physicians that might influence their prescribing habits. These lectures often take the form of informational seminars that focus on treatment options for certain therapeutic indications which often times subliminally highlight the advantages of the sponsor’s product over its competitors. Not surprisingly, the effectiveness and success of these programs is usually directly proportional to the sums of money invested in them. For example, in 2004, Forrest Laboratories (the subject of the NY Times article) planned on spending “$34.7 million to pay 2000 physicians to deliver 15,000 marketing lectures about Lexapro (an antidepressant) to their peers in one year.” The investment appears to have paid off; sales Lexapro reached $2.3 billion in 2008 even though a lower cost generic version of the drug is available. And, while the Forrest investment in medical education may appear to be a large one, it pales in comparison to the sums invested in medical education programs by much larger companies like Pfizer, Merck and others.

While certain members of Congress may be “shocked and outraged,” these practices are sanctioned by FDA. And, as long as drug makers are compliant and adhere to the rules they shouldn’t be faulted or penalized for their efforts. The point that I am trying to make is that drug makers, like all other for-profit entities, must maximize sales to generate sufficient profits remain in business. Therefore, it should come as no surprise to legislators or the American public for that matter, that drug makers use all legally available means to maximize the sale of their products. If Congress doesn’t like what drug makers are doing, then they ought to stop complaining and legislate changes to the rules. Put simply, it’s time for Congress to “put up or shut up.”

Until next time...

Good Luck and Good Job Hunting!!!!

 

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Pharmaceutical,biotechnology and other companies that sell prescription drugs and devices are deathly afraid of adverse events (AEs) associated with their products. For those of you who may not know, companies with approved prescription drugs and medical devices are required to track and report any adverse events associated with their products to regulatory agencies like the US Food and Drug Administration (FDA). If FDA receives enough AE complaints about a product, the agency will investigate to determine whether or not there may be efficacy, safety or tolerability issues with it. And, if FDA thinks that the AEs are legitimate, it may ask a company to conduct Phase IV clinical trials with the product in question or require that changes be made to the product’s label. Not surprisingly, these outcomes can be time consuming and perhaps more importantly, costly. Label changes—especially for blockbuster products—frequently lead to changes in physician prescribing habits which can translate into a loss of revenue. Despite the fact that ALL drugs exhibit AEs, many companies falsely cling to the hope that there will be few, if any, AEs reported for their products.

While drug makers are very familiar with the range of possible AEs associated with their drugs—all AEs for a drug are identified and reported during clinical trials—pharmaceutical executives are concerned about social media activities, because they fear that than the number and frequency of AEs reported for their products will increase. This, in turn, would prompt FDA and other regulatory agencies to investigate and more closely scrutinize their marketed products. As Jonathan Richman, author of the Dose of Digital Blog points out in an excellent post entitled the “Myth of Adverse Event Reporting” AEs are a fact of life for prescription drugs. And, that social media may help to improve adverse reporting. Like Jonathan, I contend that social media might allow drug makers to more effectively identify potential safety issues with a product earlier in its lifecycle and thereby minimize possible deleterious effects of the drug on certain patient populations. I think that drug manufacturers ought to begin to consider how they might effectively use social media to improve AE reporting rather than ignore the potential upside of this new medium.

The Myth of Adverse Event Reporting

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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Mark Senak, author of the EyeonFDA blog and social media enthusiast, posted a great piece about pharma’s reluctance to adopt social media and the changes in adverse event reporting-- aka pharmacovigilance--requirements that may change this attitude. 

Hat tip to Mark!

Until next time...

Good Luck and Good Job Hunting

 

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Until today, direct-to-consumer advertising (DTC) has received very little attention during the recent spate of debates over healthcare reform. The NY Times reports that several members of Congress are introducing legislation that would curb the reach of DTC advertising. While reasons for introduction of new legislation vary—ranging from moral indignation over the mention of four hour erections during prime time to tax deductions for pharma companies that engage in DTC advertising—it appears that no stone will be unturned during the ongoing debate over US healthcare reform.

For those of you who may not know, DTC advertising is allowed in only two countries—New Zealand and the US. According to a Nielson Media Research report, in 2008 drug makers spent about $4.8 billion on DTC advertising for television, radio and print ads in magazines and newspapers. Not surprisingly, supporters of DTC point out that the amount of money spent by pharmaceutical and biotechnology companies on DTC advertising is negligible as percentage of total health care spending. Nevertheless, data convincingly show that DTC advertising can increase the number of prescriptions written for newly approved drugs. Of the $235 billion spent on prescription drugs last year, approximately $8 billion was attributed to DTC advertising.

Although some academic studies suggest that DTC advertising can help people who need to start taking drugs and others to remain compliant with existing treatment regimens, the lack of fair balance in many DTC ads that promote drug benefits and downplay risks is what is driving legislation to curb its use. The recent brouhahas over Pfizer’s Lipitor commercials, Bayer Pharmaceuticals’ ad that deceptively promoted its popular birth control drug Yaz and Merck and Schering Plough’s Vytorin ads that overstated the health benefits of the cholesterol lowering drug have convinced legislators that DTC must be fixed.

The US Food and Drug Administration (FDA) Division of Drug Advertising Marketing and Communications (DDMAC) oversees and has full responsibility for DTC advertising. However, it is important to note, that under current regulations, companies aren’t required to get approval from the agency before they appear. Sharing DTC ads with FDA is completely voluntary. However, if FDA receives enough complaints about particular ads, DDMAC will review them and notify the company if regulators believe that they contain information that is misleading, unbalanced or unsubstantiated. Companies that violate DDMAC policies and guidelines are typically required to show run all future DTC ads by FDA regulators before they can shown to the public.

Because of the small numbers of patients that are typically used during clinical evaluation of new drugs, it may take as long as five years before side effects and problems with certain drugs begin to emerge. With this in mind, DTC critics argue that there ought to be a five year waiting period or moratorium on DTC advertising after a drug is approved. Interestingly, about ten years ago, a friend who works for a major pharmaceutical company told me that she always waits five years before using a newly approved drug.  At the time, I thought it was an odd thing for her to say since she had been in the business for over 15 years. However over the past five years or so, several high profile drugs that were heavily promoted by DTC advertising had to be withdrawn from the market. To that end, while DTC advertising may be “great for business,” it may not always be in the best interest of American consumers who use prescription drugs!

Until next time...

Good Luck and Good Job Hunting

 

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The rancorous debate over a regulatory approval pathway for follow-on biologics (aka biosimilars) continues to rage on in the US Congress. Despite recommendations from the Federal Trade Commission that a data exclusivity period for follow-on biologics isn't necessary and a seven year compromise offered by President Obama,the pharmaceutical and biotechnology lobbies continue to press Congress for a 12 to 14 year period of data exclusivity in any legislation for follow-on biologics. 

In a well-balanced article in today’s New York Times, Andrew Pollack diligently put forth the arguments against follow-on biologics that innovator companies have been espousing for the past decade. These include: complexity of the manufacturing processes for biotechnology drugs, potential tolerability and safety issues and perhaps, most importantly, an anticipated loss of profits that innovator companies claim “would stifle American innovation” in the life sciences. Until recently, these arguments were successfully used to hinder any substantive debates on follow-on biologics legislation. However, it  has become increasingly apparent that the American healthcare system can no longer sustain the high costs and lack of access to potentially life-saving branded biotechnology drugs. For those of you who may not know, a regulatory approval pathway for biosimilars already exists in Europe and it has been used to approve eight products since its inception in 2004.  Biosimilars are also available in Australia and have been sold for many years in less-regulated markets including India, China and elsewhere. Japan recently approved legislation for approval of biosimilars and Canada is close to finalizing its regulatory guidelines for these products.

American innovator companies recognizing the inevitability of follow-on biologics, no longer oppose legislation for approval of these molecules. Instead, these companies and their supporters have tenaciously latched on to the data exclusivity argument, presumably in a last ditch effort to preserve their profits from multibillion dollar biotechnology drug franchises that may be lost when follow-on biologics legislation is enacted.  And, for the most part, their uncompromising insistence on an excessively long data exclusivity period appears to be taking hold with members of Congress. At last count, there were more Congressional sponsors of legislation favoring a 12 to 14 year data exclusivity period than there was for those who support a 5 year data exclusively period. The five year data exclusivity period was proposed by follow-on biologics proponents because it is identical to the period required for generic versions of small molecule drugs enacted in the Hatch Waxman Act.

I have been following the follow-on biologic debate for the past eight years and, to date, I know of no scientific claims or relevant safety concerns which argue that 12 to 14 years of data exclusivity is warranted for follow-on products.  For example, no untoward safety or tolerability problems have been reported for any of the eight biosimilar products that were approved and sold in Europe for the past three years. Further, European healthcare agencies and physicians haven’t readily embraced biosimilars despite an almost 25%-30% reduction in price. The one exception is Germany (the largest generic market in Europe), where biosimilar versions of erythropoietin (Eprex) have captured 30% of the anemia market. This, in turn, has  forced some innovator companies to lower prices on their branded products.

Based on the European experience, it is likely that follow-on biologics won’t catch on quickly in the US and it may take years for them to erode the market share garnered by innovator brands.  Also, contrary to earlier assertions, it is becoming increasingly apparent that only large, well capitalized companies with sophisticated regulatory, marketing and distribution capabilities will be able to compete in the US follow-on biologics market. To that end, companies like Sandoz (Novartis) and Merck—one of the companies that originally opposed follow-on biologics legislation—will likely dominant the US follow-on biologics market.

Ironically, the biggest losers in the follow-on biologics debate will likely be the innovator companies—but not for the reasons they once cited to prevent regulatory approval of these molecules. By spending hundreds of millions of dollars lobbying against follow-on biologics legislation—rather than investing to develop their own lower cost, generic versions of blockbuster biotechnology products—innovator companies have unwittingly provided foreign follow-on biologics manufacturers with a competitive advantage when follow-on biologics are finally approved for sale in the US. Companies like Sandoz, Teva and several Indian biosimilar companies— with products already on the market in Europe, India and China—have been developing biosimilar molecules for the past fiver years or more. Their scientific and regulatory experiences with these products suggests that they will be poised to dominate the US market after legislation permitting approval and sale of follow-on biologics is finally completed. Surprisingly, Merck is the only major pharmaceutical company to publicly announce its intention to compete in the follow-on biologics market. The Merck announcement was made last fall—almost three years after Sandoz won European approval for Omnitrope, its first biosimilar product!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

 

 

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BioJobBlog and BioCrowd along with the Business Development Institute, the Journal of Communication in Healthcare and others are co-sponsoring a meeting entitled “Social Media and Healthcare” that will be held on July 23, 2009 in NYC at the Graduate Center of The City University of NY (365 Fifth Avenue at 34th Street). Topics that will be covered include:  

1. Managing regulatory and legal issues when planning and implementing social media strategies
2. Is there a role for social media in President Obama’s healthcare reform plans?
3. Why real-time social media tools like Twitter are gaining momentum and when it makes sense to use them
4. How social media has affected crisis communications in the healthcare industry
   
5. Selling social communications projects and proving ROI to senior management
   
6. Creating and participating in communities to achieve communication, educational and branding objectives
7. Planning and executing a social communications plan with little or no budget
8. Building relationships and partnerships with new healthcare media leaders beyond advertising
9. Best practices for using social communications to connect internally with employees and stakeholders
   
10. Tools, technologies, and best practices for monitoring and measuring social communications

The meeting’s agenda features case study presentations and a series of roundtable discussions on social media topics. I will be leading a roundtable discussion called “How to Build a Social Networking Site for Bioscientists.” Approximately 300 senior marketing, communications and media professionals from Fortune 1000, middle market and emerging growth companies are expected to attend from leading pharmaceuticals, medical technology/device companies, managed care providers, hospitals, healthcare media companies, government and nonprofit organizations.  

BioCrowd members can register for the meeting at a discounted rate of $155. Check it out—it will be money well spent!

Hat tip to Steve Etzler at the BDI and Mario R. Nacinovich Jr., Editor-in-Chief, Journal of Communication in Healthcare for organizing this topical and important meeting.

I hope to see you at the meeting next Thursday!!!!

 

 

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Mark Senak, who writes the outstanding Eye on FDA blog, posted an interesting article today that tracks the number of warning letters issued by DDMAC (the center that oversees life sciences marketing and advertising) over the past 12 years. Not surprisingly, the number of warning letters issued by DDMAC fell precipitously during the Bush Administration, after reaching a high during the waning years of Bill Clinton’s presidency. In fact, the number of warning letters issued by DDMAC during the first two quarters of 2009 exceeds the yearly total of warning letters issued in the past 4 of five years. However, as Mark clearly points out, the 2009 year to date number of warning letters may be artificially inflated because of 14 identical ones issued on the same day (April 2) to 14 different companies regarding internet search engine advertising. Nevertheless, it is becoming increasingly apparent that the agency is beginning to emerge from a long slumber and that US regulatory oversight may be entering a new, more scrutinizing era. 

While increasing regulatory scrutiny may be appropriate after 8 years of no regulation at all, it is important that FDA doesn’t overreact and unnecessarily stifle new drug and product development. To that end, I believe that the agency needs to be reorganized, revamped and revitalized to replace its traditionally “reactive” way of doing business with a more “proactive” one.  For example, there is a burgeoning need for regulatory guidance on the use of social media by companies in the pharmaceutical, biotechnology and medical devices and diagnostics industries. Unfortunately, FDA has been unwilling or unable to enunciate a cogent regulatory strategy or any meaningful guidance on this topic. Consequently, many life sciences companies have refrained from using social media because they simply don’t know how to implement it in the current regulatory environment. I believe that FDA, not the companies it regulates, should take the lead on this issue.

Finally, it is becoming increasingly apparent that many companies will continue to refrain from using social media and other Web 2.0 tools until FDA crafts some useful guidance on these topics. Sadly, Web 3.0 is just around the corner and the agency is still struggling with regulatory guidance for corporate websites. Maybe Congress needs to craft some new FDA modernization legislation—it has been 12 years since the last modernization bill was passed!

Until next time....

Good Luck and Good Job Hunting!!!!!!!!!

 

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As the Congressional debate over follow-on biologics slogs on, the Obama Administration has finally weighed in and backs 7 years of data exclusivity for follow-on biologics. As you may recall, innovator companies want a 12-14 year data exclusivity period whereas follow-on biologics manufacturers are seeking a 5-year period (which is identical to the data exclusivity period for small molecules generic drugs outlined in the Hatch Waxman Act). What this means—based on the Obama Administration's proposal—is that a follow-on biologic manufacturer must wait seven years from the date of approval for the innovator (branded) drug before the US Food and Drug Administration could consider approval of a follow-on version of the molecule.

It is not surprising that the Obama Administration supports a 7 data exclusivity period--it is, after all, a compromise between the 5 year period sought by the follow-on manufacturers and the 12-14 years that the innovator companies are seeking. And, Mr Obama has repeatedly shown a willingness to compromise when it comes to getting important legislation passed. Hopefully, Congress will take the Obama Administration's compromise to heart and pass follow-on biologics legislation as quickly as possible.

 Until next time...

 Good Luck and Good Job Hunting!

 

 

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The debate, if you can call it that, over whether or not interactive social media platforms like Facebook and Twitter can be used in the life science industry is moving forward at glacial speed. I decided that it was time to propose some ideas rather than continue to admonish the US Food and Drug Administration (FDA) for a lack of guidance.

There are several reasons which may explain the inertia surrounding the adoption of social media by pharmaceutical, biotechnology and medical devices and diagnostics companies. First, and perhaps foremost, FDA has been consistently reluctant to craft any useful guidance on the use of Web 2.0 technologies for research, clinical or promotional purposes. The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) is still trying to figure out how to regulate website content. Is it any wonder that FDA is reluctant to tackle the regulatory implications and issues associated with social media platforms like Facebook and Twitter? Second, a majority of social media advocates— who are leading the charge at many life sciences companies—are marketing and advertising executives who tend to look at social media strictly as a promotional tool. Finally, much of what takes place at life sciences companies is proprietary and confidential—information flow between the company and its employees and the public is fastidiously monitored and tightly regulated. Because of this, the life sciences industry’s “process” is intentionally opaque—which is contrary to the goals of social media which is to promote transparency (or the illusion of it).

There is no doubt that the life sciences industry is the most highly regulated industry on the planet. While this represents a formidable challenge for adoption of social media, it is by no means insurmountable—especially if social media is used for purposes other than branding, marketing and advertising. For example, the most straight forward application of social media at life sciences companies would be in the areas of corporate recruitment and employee retention. Many Fortune 500 companies outside of the life sciences industry have been using Facebook, MySpace and LinkedIn for years for recruiting purposes. While not commonly acknowledged, life sciences companies have quietly begun to use Facebook, LinkedIn and MySpace to recruit prospective employees. Interestingly, the new kid on the block—Twitter—looks to potentially be a more powerful recruiting tool than any of its predecessors. Unfortunately, employee retention is no longer a priority at many companies. However, before the economic meltdown a number of companies, most notably Best Buy, were experimenting with social media to retain talented employees.

Another potential use of social media is for pharmacovigilance and adverse events reporting. Companies with approved products on the market are required by FDA (and other regulatory agencies that approved their products) to set up post marketing surveillance programs for adverse events reporting. By law, companies that receive adverse events reports from consumers, physicians or other entities must report them to the regulatory agencies that approved the product. Regulatory agencies maintain adverse events databases for all approved drugs and devices to monitor drug safety.  If designed and implemented correctly, interactive social media platforms like Facebook and Twitter (which operates in real-time) would make excellent pharmacovigilance and adverse reporting tools. Quite coincidentally, John Mack, who runs the Pharma Marketing Blog, reported a partnership between UCB and PatientsLikeMe.com to create a pharmacovigilance reporting platform for UCB products.

Recruiting patients for participation in clinical trials (to assess efficacy and safety of prospective new drugs) has become extremely challenging over the past few years.Traditional patient recruitment strategies include print, television and radio ads and in some instances, websites. All of these recruitment methods are costly, labor intensive and limited in their effectiveness because they only reach small number of prospective clinical trial participants. I contend that Facebook with over 200 million users, LinkedIn with members in over 140 different countries and Twitter which is growing rapidly would be ideal for clinical trial recruitment and retention purposes. Others have also proposed this idea.

Finally, while the use of social media to promote approved drugs and devices may be difficult because of regulatory constraints, it can be utilized to keep the public informed about prospective new medicines and promote a company’s image or brand. There is no question that the public perception of the pharmaceutical industry has been severely tarnished over the last few years.  The industry’s continued lack of transparency and failure to adequately disclose potential safety risks about some approved products continues perpetuate a negative image. One way to restore public trust and confidence is to use social media to actively engage the public in conversation on wellness, addressing unmet medical needs and prospective new medicines and treatments that are being developed. Also, social media platforms could be employed to showcase community outreach programs and discuss educational initiatives to improve science education and training.

Social media is no longer a new phenomenon or technology. It is a legitimate form of communication which has become an integral part of the Web 2.0 experience. I suspect that the life sciences industry will have to make a decision about social media in the not so distant future—or possibly miss a potentially game-changing business opportunity. And, as Ken Kesey aptly said in Tom Wolfe’s ‘The Electric Kool-Aid Acid Test’—“You’re either on the bus…or off the bus.”

 Until next time...

 Good Luck and Good Job Hunting!!!!!!!!

 

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Mark Sendak, a social media enthusiast and author of the Eye on FDA blog, wrote a great post today about an article he saw in the Washington Post entitled “Drug Firms Jockey for Space Online.”

Mark wrote: “Flock?  Flock?  FLOCK?  The only way you could use the term "flock" in connection with pharmaceutical firms and social media is to say that companies are a scared flock of geese.” He goes on to castigate FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) for a lack of a coherent regulatory framework and guidance for the use of social media in the life sciences industry.

Mark aptly describes DDMAC’s guidance surrounding social media and the pharmaceutical industry this way. “No one knows, and DDMAC apparently makes this stuff up as they go along. That is the kind of Whack-a-Mole game DDMAC plays.  We won't tell you what is off limits, until you do it and then WHACK! Is this anyway to run a pharmaceutical industry?

I am in total agreement with Mark on this issue. Despite the rapid adoption of social media by other industries, FDA has consistently been reluctant to issue any regulatory guidance what so ever on the topic despite assertions to the contrary. Unfortunately, when it comes to social media and the pharmaceutical industry, FDA’s usual approach to regulatory guidance—reactive rather than proactive—is still alive and well. As you may recall FDA previously sent warning letters to no fewer than 14 pharmaceutical and biotechnology companies admonishing them on their placement of product ads on search engine results pages. The fact that 14 different companies received warning letters on this issue reflects the confusion and lack of guidance offered by FDA on social media and the use of Web 2.0 technologies to promote or support the sale pharmaceutical products.

The growing popularity and inevitability of social media suggests that DDMAC officials along with industry representatives must begin to consider crafting a preliminary regulatory framework for its use in the life sciences industry. Like it or not, social media is here to stay!

Hat tip to EyeonFDA!

Until next time....

Good Luck and Good Job Hunting

 

 

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A much-anticipated Federal Trade Commission (FTC) report was released on Wednesday that will likely help House Energy and Commerce Chairman Henry Waxman bolster support for his fledgling follow-on biologics (FOB) bill. For those of you who haven’t been closely following the debate over proposed legislation to create a regulatory framework for approval of FOBs in the US, I provide a brief synopsis.

The Promoting Innovation and Access to Life-Saving Medicines Act (H.R.1427) introduced by US Representatives Henry Waxman (D-CA), Frank Pallone (D-NJ) and Nathan Deal (R-GA) calls for an abbreviated development pathway (at the discretion of the agency), the possibility of substitution or interchangeability (if the follow-on biologics manufacturer can prove a high degree of structurally similarity and an identical mode of action) and five years of data exclusivity. In contrast, The Pathways for Biosimilar Act (H.R. 1548) introduced by US Representatives Anna Eshoo (D-CA), Jay Inslee (D-WA) and Joe Barton(R-TX) requires clinical data, rigorous immunogenicity testing and limits on interchangeability and substitution provisions for follow-on biologics. Further, it calls for a minimum of 12 or up to 14 years of data exclusivity for innovator companies—a period during which FDA can’t rely on innovator data to approve follow-on biologics. For example, if a biotechnology drug was approved in 2009, the earliest that FDA could consider and approve an application for a competing follow-on product is 2021.

The FTC report concluded that a 12- to 14-year wait is unnecessary because follow-on biologics will not be offered at the same steep discounts as traditional generic drugs. It also pointed out that no evidence exists that biologic patents will not hold up. The agency estimates follow-on biologics would be sold at discounts ranging from 10 percent to 30 percent. Not surprisingly, the FTC did not recommend a specific number of exclusivity years. This allows legislators to continue to squabble and debate the point ad nauseum, until concessions are made by both innovator and follow-on biologics proponents.

The measure by Eshoo and Barton has garnered 88 co-sponsors, while Waxman and Deal's bill has 11. In the Senate, the Health, Education, Labor and Pensions Committee reached a bipartisan compromise on follow-on biologics in 2007 that allowed for 12 years of exclusivity, but that deal seems unlikely. Democrats are trying to address generic firms' concerns that brand companies could make slight changes to their products and start the exclusivity period over again. Some senators introduced a more generic-friendly bill like Waxman's earlier this year.

Conventional wisdom suggests that the data exclusivity provisions in the final legislation will be five years—a period identical to that provided stipulated in the 1984 Hatch Waxman Act, which created the US generic pharmaceutical industry. 

Stay tuned for new updates on this unfolding drama!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!! 

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As we all know, the H1NI pandemic has been raging on for close too 10 ten days now. Curiously, “Fear & The Flu: The New Age of Pandemics” is the title this week’s cover story in Newsweek magazine. From an informational standpoint point, “this may be too little, too late”—as the old saying goes. While the Internet has been around for over twenty years now, government agencies, most notably the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continue to rely almost exclusively on old media to communicate with the American public during infectious disease outbreaks. Apparently, the administrators who run these government agencies haven’t been listening closely enough to President Obama’s assertion that “we live in the digital age.”

Communications between the public and government health officials is vital when trying to manage and control infectious disease outbreaks. “Every single government agency as well as companies and non-profits need to be digitally literate and competent in a time of pandemic” asserts Eye on FDA blogger Mark Senak. For their performances in recent infectious disease outbreaks, Mark gives CDC an “A” for effort—although there is substantial room for improvement. FDA on the other hand didn’t fair as well. “The FDA is not nearly as sophisticated in terms of digital. Their only Twitter account is for food recalls.  And their YouTube channels are all confusing and unorganized. They have a long way to go.”

The Internet was originally designed as a digital tool to transmit and move large amounts of information from one place to another. That said, it is also a powerful communication vehicle that can be used to broadcast valuable, scientifically-accurate information during infectious disease outbreaks by leveraging social media tools like Twitter, Facebook and instant messaging. To that end, it’s time for public health agencies to recognize the power of digital media and craft communication plans that can be implemented in the next infectious disease outbreak.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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One day after the US Food and Drug Administration (FDA) approved Dysport, a new product that will compete with Botox, the agency ordered that labels for all botulinal toxin-based drugs must carry a black box safety warning. For those of you who may not know, that is the most stringent kind of safety warning label—viewed by many in the industry as “the kiss of death”— that the agency can order to appear on the products that it regulates. 

Black boxes (literally a black box with bold-face risk information) are typically reserved for medications that are know to have serious or life-threatening side effects or risks. For example, many antidepressants—most recently serotonin re uptake inhibitors (SRIs)—carry black box warnings of increased danger of suicidal thoughts and actions. 

Over the last 20 years FDA approved Botox to treat crossed eyes, eyelid spasm, severe underarm sweating and cervical dystonia (a painful and severe neck condition that can cause an abnormal head position) Cosmetic Botox was approved to treat skin folds and wrinkles in 2002. Allergan, the company that manufactures Botox, reported $1.3 billion in worldwide sales of the drug in 2008. 

Botox and Dysport are injectible products made from the highly paralytic toxins produced by the bacterium Clostridium botulinum. Botulinal toxins interfere with muscle contractions and patients with botulism food poisoning exhibit what is known as “flaccid paralysis.” Afflicted individuals cannot breather and will die without early intervention. FDA order the black box safety warning labels because there were numerous reports of serious health problems, complications and deaths caused by the drug spreading from the site of injection to other parts of the body. 

Most of the problems with Botox resulted from the overuse of Botox for unapproved treatments like limb spasticity in children with cerebral palsy (although misuse of the product for cosmetic purposes may have also contributed to the problems). The agency will now require that all botulism-based products carry a black box warning explaining that the medication has the potential to spread from the site of injection to other body sites—with the potential to cause serious problems like difficulties swallowing or breathing. Also, it will require manufacturers of botulinal products [Allergan (Botox) and Ipsen/Medicis Pharmaceuticals (Dysport)] to send physicians letters warning of the risks and to craft medical guides given to patients at the time of injection. 

The new warning labels will likely do little to discourage the rampant use of Botox and Dysport for cosmetic indications. After all, beauty will always come before safety! 

Until next time... 

Good Luck and Good Job Hunting (looking younger may help)

 

 

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Twitter, which is currently de rigueur in social media circles, is emerging as one of the most powerful branding and marketing social media tool that has been developed to date.   While other industries are already exploiting Twitter’s powerful marketing reach (to hawk their wares), drug makers have been reluctant to adopt Twitter and most other forms of social media. Industry analysts and company insiders contend that pharma’s reluctance to adopt social media can be attributed to the US Food and Drug Administration’s (FDA) lack of guidance on its use for promotional purposes. At present, it is anybody’s guess when this guidance may be issued, if ever.

Nevertheless, as always, there are a few daring companies willing to “boldly go where no pharma company has gone before”—in this case—Twitter! These companies include Boehringer Ingelheim (BI), Astra Zeneca, Novartis and Pfizer. According to a post on the Advance Market WoRx blog, BI is leading the way among pharma company Twitterers, with 679 following, 745 followers and 47 tweets. AstraZenecaUS has 136 following, 440 followers and 22 tweets. Pfizer has 351 following, 462 followers and 48 tweets.  Novartis has 0 following, 681 followers and 40 tweets (I guess Novartis has a thing” against following people).

Unlike its fellow pharma Twitters, BI—which began using Twitter in November 2008—actually uses it as an interactive and conversational microblogging platform (as it was intended). The other pharma company Twitters use it almost exclusively “as a one-way PR feed” says Ellen Hoenig Carlson at Advance Market WoRx. According to a post on the Pharmafocus website, "Boehringer has incorporated Twitter into its wider communications strategy and is using the site regularly to engage its stakeholders. In addition to posting press releases, BI uses Twitter to recommend web-based information about therapeutic areas and articles that its followers might find interesting or useful. To keep its finger on the pulse of the Twitterverse, BI uses media scanning programs to help monitor online conversations and responds quickly to join in or start up Twitter conversations.”

Kudos to Boehringer for recognizing Twitter’s potential to communicate with patients, physicians and other interested parties. I hope that more pharmaceutical companies begin to use Twitter and other forms of social media to engage and improve communications with their stakeholders.

Until next time...

Good Luck and Good Twittering (or should it be Tweeting?) 

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Earlier this week, the US Food and Drug Administration (FDA) sent warning letters to 14 different pharmaceutical and biotechnology companies to advise them that their approach to Internet advertising is violating federal pharmaceutical advertising and marketing guidelines and regulations. While the agency’s attempt to regulate Internet-based drug advertising is laudable, the fact that warning letters were sent to 14 different life sciences companies means that there is a poor understanding of the regulations regarding use of Internet—and more recently, social media—to market and advertise drugs, medical devices and diagnostics. This isn’t surprising because FDA has yet to issue any meaningful guidance on the use of the Internet and social media to market life sciences industry products. The reluctance of the agency to issue guidance is very puzzling—the use of web based-advertising and social media by life sciences companies has exploded in the past few years.

In a post today on the EyeOnFDA blog, Mark Sendak pointed out that Twitter is fast becoming the medium of choice for life sciences messaging, branding and product promotion. Despite FDA’s lack of guidance on the use of social media, an increasing number of life sciences companies and organizations are using it to stay in touch with their stakeholders and constituents. For example, the Juvenile Diabetes Research Foundation, the Lancet, the New Scientist, Roche, Novartis, AstraZeneca, Boehringer, Cell Therapeutics and Novartis and others have Twitter accounts. Many of these companies also have fan pages or accounts on Facebook. 

It is becoming increasingly evident that the agency will have to issue guidance on social media sooner rather than later. The wide reach, immediacy and highly interactive nature of social media suggest that the current wait-and-see attitude of FDA is no longer feasible. To jump start the discussion, Social Pharmer, a group of life sciences social media enthusiasts are holding an “unconference” in Boston on April 21, 2009. I hope that FDA sends representatives to this grassroots meeting!!!

Until next time....

Good Luck and Good Job Hunting!!!!!!!

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Today's New York Times reported that the US Food and Drug Administration (FDA) issued warning letters and ordered 14 pharmaceutical and biotechnology companies to stop running what it calls misleading ads on internet search pages displayed by search engines like Google. The agency faulted the companies for failing to identify product names (brand) and not listing potential side effects (only benefits) for the drugs. In other words, the ads lacked “fair balance” something that FDA stresses and that all drug makers are very familiar with. 

Drug makers and other interest groups pay search engines like Google to place ads on search result pages after someone types in a related search word. The sidebar ads typically contain a eye-catching headline about a relevant medical condition or product and links to websites promoting certain products. The companies receiving warning letters included: Bayer, Biogen Idec, Boehringer Ingelheim, Cephalon, Eli Lilly, Forrest Laboratories, Genentech, GlaxoSmithKline, Johnson and Johnson, Merck, Novartis, Pfizer, Roche, and Sanofi-Aventis. Not surprisingly, most of the world’s largest and most profitable were guilty of running misleading Internet search engine ads.

Historically, drug companies and FDA have engaged in a cat and mouse approach when it comes to advertising and marketing drug and medical devices and diagnostics. This is because FDA’s existing regulations that guide marketing and advertising practices are relatively lax and it provides drug makers with the opportunity to see how far they can push the agency before “they get caught.” While this practice may have been acceptable for print and television advertising, it may no longer be appropriate for Internet advertising— which potentially has a much broader and larger reach than traditional media because there are not national borders on the Web. Unfortunately, FDA has been slow (reluctant?) to react to digital media and is even more perplexed about social media and the drug industry. Rather than continue to play cat and mouse, I think it would be in the best interest of consumers if FDA and drug makers would sit down and craft new guidance on regulating Internet advertising and marketing practices. It is becoming increasingly apparent that the old rules are no longer sufficient as digital and social media continue to evolve.

Until next time....

Good Luck and Good Job Hunting!!!!!!! 

 

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The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of  about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.

President Obama’s promise to restore science to its rightful place, his reversal of the ban on federal funding for embryonic stem cell research and an unwavering commitment to alternate energy technologies suggest that the future may be very bright for bioscientists. For example, there are massive hiring initiatives at federal agencies like the US Food and Drug Administration (FDA) and the Unites States Department of Agriculture (UDSA) — as the Obama administration attempts to overall these agencies— and funding levels at the National Institutes of Health are on the rise (aided in part by a $200 million Challenge Grant stimulus program).

While the road to economic recovery may be a long one, graduate students and postdoctoral fellows who are currently engaged in life sciences research should “stay the course and not jump ship just yet.” The life sciences industry is more recession proof than others and it will be one of the first to experience an economic turn around. And, when it does it is best to prepared to find a job!

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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Colony Collapse Disorder (CDD) a mysterious syndrome that kills adult worker bees outside of the hive has been plaguing Europe and the US in recent years. The US Department of Agriculture (USDA) reports that American beekeepers have lost 37% of their hives to CCD in 2008 after losing 31% the year before. The government estimates that a third of the US food supply may be at risk--$15 billion annually in vegetables, nuts and fruits from plants that depend on bee pollination. The cause of CDD is still hotly debated but many scientists believe that it is caused by a virus

A start up company in Miami FL (my old stomping grounds) called Beeologics is developing a vaccine against all of the apiary viruses that could be responsible for CDD. The company was started by two Israelis, Eyal Ben-Chanoch at tech entrepreneur who helped design the first Intel Pentium chip and Ilan Sela a bee genomics expert. 

The vaccine is pending FDA approval and Beeologics expects it to hit the US market this summer and sell it for $2 per dose. A hive will need one dose per month and current estimates suggest that there are 2.5 million hives in the US. Not a bad revenue stream!

For those of you who may not know, bee keeping is big business and can be lucrative for beekeepers. I learned everything I know about bee keeping as an undergraduate at Cornell when I took Introduction to Beekeeping in my senior year. It was one of the best courses that I ever took at Cornell because it was taught by an entomologist who was also a commercial beekeeper!   Since then, I have always been extremely fond of honey bees—they are fascinating creatures.

Until next time…

Good Luck and Good Job Hunting!!!!!!

 

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Tainted pistachio nuts are the culprit for this week’s Salmonella outbreak.  Fortunately, Kraft Foods’ quality unit was doing its job and was able to alert consumers about the problem before the outbreak reached epidemic proportions. At present, there are only two suspected cases of Salmonella gastroenteritis that may be linked to tainted pistachios. The contamination has been traced back to a California company which, according to reports, is the second leading producer of pistachios in the US.

As I have mentioned several times before, Salmonella outbreaks are nothing new and not out of the ordinary in the food industry. However, what is new is the growing lack of regulatory compliance that seems to be pervasive at American food manufactures. Many blame declining food safety on the US FDA’s lack of trained inspectors. While this may play a role, I believe that the real problem lies with the failure of many food industry executives to make a commitment to quality outlined in FDA’s Current Good Manufacturing Practices (cGMPs). 

I have been teaching cGMP to biotechnology students for the past six years or so.  I always tell them that the regulations are meaningless unless management makes a commitment to quality. And, the only way to accomplish this is by insisting that all manufacturing taking place at a company stringently adheres to all GMP regulations and guidelines. For those you who may not be familiar with cGMPs, they are the minimum regulatory standards that must be met to insure US product (food, drugs and cosmetics) quality and safety.

Over the past decade or so, Americans have grown accustomed to a wide variety of choices when it comes to raw and processed foods. To meet demand, US food manufacturers must source and import fruits, vegetables, spices and other foodstuffs from all over the world. Regardless of the origin of a food source, cGMPs clearly state the onus is on the manufacturer (not the supplier) to perform the necessary tests to insure food safety and quality. The recent spate of Salmonella outbreaks suggests that some food manufacturers are either cutting corners or don’t fully understand what testing is necessary to guarantee food safety. Unless something changes, Americans confidence in the safety of US food supply will continue to wane.

Until next time...

Good Luck and Good Easting (avoid pistachios)

 

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Previously, the US Congress proposed legislation to create a regulatory approval process to allow the Food and Drug Administration (FDA) to approve generic versions of blockbuster biotechnology drugs known as follow-on biologics (FOBs). While a regulatory pathway exists for approval of generic versions of small molecule drugs (as outlined in the Hatch-Waxman Act) there is no legally-approved regulatory pathway to bring FOBs to market in the US. In contrast with the US, the European Union crafted legislation five years ago that allows biosimilars —the name given to FOBs in Europe—to be approved and sold in EU member states. Since 2004, the European Medicines Agency (EMEA), the EU regulatory body, has approved the sale of six biosimilar drugs with many more in the queue awaiting regulatory review.

The debate over FOB legislation started in the US about 10 years ago when patent expiry of many  multi-billion blockbuster biotechnology drugs was fast approaching. From the beginning, many so-called innovator companies (the companies that produced the original branded biotechnology drugs) and the trade associations that represent them on Capital Hill, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Manufacturing Association (PhRMA), aggressively lobbied against any form of FOB legislation. However, late last year, several senators introduced legislation that would permit FDA to approve generic versions of many blockbuster biopharmaceutical products following patent expiry. The proposed legislation stipulated that FOB manufacturers would have to wait 12 years —after patent expiry of previously approved biotechnology drugs—before generic versions of those drugs could be sold in the US. That legislation, which unabashedly favored innovator drug manufacturers, passed the Senate health committee but died without being voted on. The new measure, introduced Thursday, cuts by more than half — to 5 years, from 12 — the time allowed before cheaper versions of biotechnology drugs could compete with the originals. A similar bill was introduced two weeks ago in the House by Representative Henry A. Waxman, Democrat of California and chairman of the Energy and Commerce Committee.

While the proposed reduction in the so-called “FOB waiting period” is commendable, I don’t think that any waiting period is necessary before FOBs can be sold in the US. It is difficult to understand why innovator companies require an additional patent protection—beyond the 20 years already afforded to them under US patent law—to continue to sell their blockbuster products! To that end, Jeff Joseph, a spokesman for the BIO said that the FOB waiting period reduction, “.... Would jeopardize patient safety and undermine our ability to develop future cures and therapies.” I believe that the FOB waiting period being championed by innovators companies is nothing more a thinly veiled attempt by them to continue to maintain monopolistic control over lucrative multibillion dollar biopharmaceutical drug franchises. Biotech executives have vowed to vigorously fight the new legislation, saying it could result in unsafe medicines, fewer cures and fewer jobs in biotechnology centers like Boston, California and elsewhere. Interestingly, similar arguments were put forward by the pharmaceutical industry before the Hatch-Waxman act was passed by Congress in 1984..

Despite the claims that FOBs will stifle innovation and may jeopardize the safety of Americans, the current high costs and lack of access to affordable healthcare will almost certainly leave Congress no choice but to pass legislation that permits the marketing and sale of FOBs in the US. While FOB legislation is a likely fait accompli, US drug manufacturers remain steadfastly opposed to any FOB legislation. I believe that innovator company opposition to FOB legislation is really a “red herring” that serves to detract attention away from the real issue that the drug industry is deathly afraid of federal regulation of drug prices. Interestingly, the US is one of the only countries in the world where drug prices are not regulated or controlled by the government. This permits drug manufacturers to set prices based exclusively on “what price the US market will bear.” In other words, they can charge as much as they want for their drugs, as long as third party payors, insurance companies and Medicare and Medicaid agree to continue to cover the costs of the drugs that they manufacture (it should come as no surprise to anyone that the American pharmaceutical and biotechnology markets are the largest and most financially lucrative in the world).

I have no doubt that innovator companies will continue to fight hard and as long as possible prevent adoption of legislation regulating the approval of FOBs. After all, there are huge sums of money and corporate profits at stake. Like it or not, FOBs will ultimately be sold in the US—the current costs of drug and healthcare are simply too high to sustain. Despite a fierce decade-long struggle, most American drug makers will privately concede that sale of FOBs in the US is inevitable. Nevertheless, innovator companies will likely not publicly endorse FOB legislation until the US government provides them with assurances that it will not seek to regulate American drug prices for the foreseeable future.

Until next time...

Good Luck and Good Job Hunting!!!!!!

 

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I just returned from a weekend of teaching regulatory affairs to biotechnology students at Georgetown University where I tried to convince them that the US Food and Drug Administration (FDA) is fundamentally sound despite its near demise during the Bush administration. Even before the Bush-induced wreckage, the agency was chronically understaffed, under funded and had serious leadership and morale problems. This, coupled with two nationwide Salmonella outbreaks in the past year, several highly publicized drug recalls, and steadily declining drug approval rates has prompted its critics to propose that FDA be split into two separate agencies—one that oversees the drug industry and another that would have responsibility for cosmetic and food safety. For those of you who may not know, FDA became responsible for oversight and regulation of the food and drug industries, in addition to the drugs, after passage of the Food, Drug and Cosmetic Act in 1938.

Drug industry advocates and longtime FDA critics contend that the agency as it exists today can no longer effectively oversee and insure the safety of American food and drug supplies. Critics argue that the history of FDA suggests that the agency focuses on medical products and only focuses on food safety when a crisis comes up. And when they occur, FDA is so distracted that it interferes with the drug review/approval process. While this is what FDA critics want you to believe, it is simply not the case. Despite its recent problems, the FDA has historically done an outstanding job when it comes to drug and food safety—when it is funded and staffed to appropriate levels.

Unbeknownst to the American public, food borne illnesses are very common and Americans are only alerted when the outbreaks reach a certain size. While the recent Salmonella outbreaks were larger in scope and breadth than past outbreaks, they were not extraordinary. However, they were extremely media worthy at the time that they were reported on. You may recall that at the time of the outbreaks, the American economy was beginning to fail and there was an inordinate amount of China, Mexico and free trade bashing going on in the US. Unfortunately, the news media decided to exploit the outbreaks to make a case that Americans ought to reduce their reliance on imported foods—a practice that was beginning to cut into the revenues of the US agriculture and food industries. Ironically, the Salmonella outbreaks might have been prevented if the production facilities (owned by American companies) were compliant with FDA mandated quality control and assurance regulations which were designed to insure food safety.

Drug industry advocates who argue that FDA ought to be split into two separate agencies have financial interests rather than safety concerns in mind.  As an investment banker or VC will tell you, slow, new drug approval rates can have serious financial consequences for the companies that are developing them—it can literally cost a company millions of dollars a day for every day the drug is kept off the market.  Interestingly, when FDA increased its drug approval rates in the late 1990s and early 2000s, there weren’t many industry insiders advocating a break up of the agency. Only recently, as FDA has become more risk adverse which in turn, has caused the new drug approval rates to slow again have critics begun to call for massive organizational changes at FDA.

Like I told my biotech students over the weekend, the only mechanism by which FDA can insure food and drug safety is by conducting regular inspections of drug and food manufacturing facilities. Unfortunately, FDA hasn’t been able to keep up with its mandatory inspections schedule because the agency has been under funded and poorly staffed for over a decade. Several FDA inspectors, who I talked with suggested that routine inspections of manufacturing facilities takes place every three to five years rather than every two years as required by FDA regulations. While in theory this shouldn’t affect a company’s ability to remain compliant with FDA regulations, in reality it does. Put simply, pharmaceutical and food companies, like most other for profit industries are incapable of policing themselves in the absence of regulatory oversight.

I ‘m not certain that the agency needs to be split into two separate agencies to continue to insure the safety of the American drug and food supplies. What I know is the agency needs more funding and much larger numbers of trained inspectors to be successful. In my opinion, the safety of the American food and drug supplies can only be guaranteed if the companies regulated by FDA make a commitment to quality manufacturing and play by the rules.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

 

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As many of you know, the life sciences industry, one of the most highly regulated industries of the economy has been hesitant and reluctant to embrace social media to reach out to patients, physicians and the lay public. This is because the US Food and Drug Administration, specifically Division for Drug Marketing, Advertising and Communications (DDMAC), has been mute on the subject and hasn’t issue one iota of guidance on the use of social media in the pharmaceutical, biotechnology or medical devices/diagnostic industries.

Mark Senak, a regulatory affairs lawyer and owner of the blog eyeonfda.com, invited Dr. Jean Ah Kang, Special Assistant at DDMAC in charge of Web 2.0 policy development to talk about FDA’s views and ideas about social media and its use in the life sciences industry. Listening to the 15 min podcast would be, according to Mark, “time well spent” for social media advocates in the pharmaceutical, biotechnology and medical devices/diagnostics sectors.

Hat tip and much “love” to Mark who wrote “BTW, I absolutely expect waves of love for this (the podcast)."

Until next time....

Good Luck and Good Listening!!!!!!!!!! 

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According to a report on NPR’s All Things Considered program, the Obama Administration has nominated Margaret Hamburg, MD to head the US Food and Drug Administration. Dr. Hamburg is a former health commissioner in New York City who has worked on issues surrounding infectious diseases and bioterrorism. In New York, she instituted a needle-exchange program to help prevent the spread of HIV. She also set up a program, in which health workers went to tuberculosis patients’ homes to help them manage their drug regimens.

A Harvard Med School graduate, Dr. Hamburg was an assistant secretary of health and human services during the Clinton administration and now works at the Nuclear Threat Initiative, which tries to cut the threat from nuclear, chemical, and biological weapons. She opposes abstinence-based sex education in public schools and has been a critic of the marketing practices of the pharmaceutical industry. Further, Dr. Hamburg is a leading advocate for changes in the nation’s public health policies and infrastructure, from local health departments to the highest levels of government. Finally, after eight years of mismanagement and poor leadership, the agency has somebody at the helm with intelligence, experience and is an advocate for change. 

Kudos to Team Obama!

Until next time...

Good Luck and Good Job Hunting (FDA is hiring)!!!!!

 

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The Eye on FDA blog reported today that AstraZeneca and Sanofi-Aventis have joined the ranks of Abbott, GSK, J&J and SanofiPasteur on YouTube. Pharmaceutical companies are taking advantage of the power of YouTube and other social media sites because regulatory guidance hasn’t been issued on its use to promote products or brand awareness. In other words, this is uncharted territory and companies can essentially 'test the waters' to see how far regulatory agencies will let them go.  I suspect that early life sciences company adopters of social media will garner substantial ROI before regulatory guidance is issued.

A lack of regulatory oversight, the ability to manage and control content and the low costs associated with creating Internet videos make YouTube and other social media sites attractive to pharmaceutical and biotechnology companies. The life sciences sector is just beginning to recognize the power of social media and the role that it may play in promoting products and brand awareness to consumers.  Expect many more life sciences companies to experiment with social media in the near future--its a veritable goldmine!

Until next time…

Good Luck and Good Video Watching!!!!!!! 

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About a year ago, I was eating lunch and bunch of pharma executives were at the table next to me. I inadvertently overhead bits of their conversation and I heard the words, Facebook, MySpace and YouTube mentioned. This suggested to me that pharma was more aware of social media (and its business implications) than pharma publicly cared to admit. Pharma has been reluctant to embrace social media because of possible legal and regulatory ramifications. Nevertheless, a few companies have decided to boldly go where no pharma company has gone before—to YouTube.

The Eye on FDA blog, which is very bullish on social media, has been keeping aof pharma companies that have created channels on YouTube, the video site owned by Google. To date, Sanofi Pasteur, GSK, Abbot and JNJ have taken the YouTube plunge (see SanofiPasteurTV , GSKVision, AbbottChannel, andJNJHealth).  I suspect that pharma companies are willing to take a risk on YouTube, because unlike other social media platforms, they can disable the functionality that allows viewer to leave comments, kudos or kvetches after viewing videos. This shields the companies from unwarranted claims, misinformation about its products and negative publicity.

At present, the US Food and Drug Administration, has issued little or no guidance on the use of social media by drug makers. This means that drug makers are in uncharted territory and can experiment with social media without fear of much regulatory oversight or scrutiny.  Now that pharma has broken the social media barrier, I wonder whether MySpace, Facebook and Twitter (the hottest new social media tool at the moment) will be next. Interestingly, I learned yesterday that Novartis uses twitter and can be followed @Novartis.

Off the record conversations with MySpace representatives suggest that a number of pharmaceuticals have quietly created branded product pages on MySpace for years.  As the MySpace rep put it, how can you ignore an audience of 60 million people?  Further, Facebook’s fan pages are growing in popularity and don’t be surprise to see pharma pages begin to appear there. It will be interesting to see how pharma will incorporate social media into its business and marketing models in the future.

Until next time…

Good Luck and Good Video Watching!!!!!!!!

 

 

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Allergan, the drug maker that brought us Botox is at it again! The company has a new FDA-approved drug called Latisse that can be used to grow longer, lusher eyelashes. It will be available by prescription at the end of this month.

Latisse contains the same prostaglandin analog that is found in Allergan’s Lumigan, an eye drop treatment for glaucoma. A side effect of the analog is to make the eyelashes of many patients who use the eye drops longer and fuller. Other side effects can include red, itchy eyes and changes in eyelid pigmentation.

Allergan conducted a 16 week clinical trial with about 280 volunteers to assess the safety and efficacy of Latisse. In the study, half of the participants used Latisse daily for 16 weeks. Study results showed that the eyelashes of patients treated with Latisse typically grew 25 percent longer, 106 percent thicker and 18 percent darker. While 3.6 percent of patients experienced eye itching and red eyes, none exhibited a change of eye color. These results were reviewed by the Food and Drug Administration, which approved the drug in late December, 2008.

While some medical experts are concerned about these Latisse’s side effects, the financial upside for the drug is considered by some analysts to be substantial. At present, the annual size of the worldwide mascara market is about $5 billion. Allergan expects sales of Latisse to eventually rival those of Botox —Allergan’s other FDA-approved drug used for therapeutic and cosmetic purposes. Sales for cosmetic use of Botox were $600 million in 2007.

Longer, lusher lashes will come at a price for the people who chose to get a prescription for Latisse. Unlike mascara which is relatively inexpensive (so I am told), a monthly dose of Latisse will cost $120. However, according to my wife, longer, lusher lashes are the equivalent of the Holy Grail for most women. When I mentioned the Latisse’s monthly cost, she said quickly replied “I don’t care. I would still do it”—this from a woman who rarely wears any make up. Although my wife doesn’t constitute a valid statistical sample size, her responses suggests that Latisse just might be the biggest thing to hit cosmetic medicine market since well—uh— Botox!

Until next time…..

 

Good Luck and Good Job Hunting (try Allergan, they are hiring!)

 

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The Bush administration spent the last eight years trying to weaken and dismantle the US Food and Drug Administration (FDA).  I thought the carnage at the agency would end in the waning days of one of America’s worst leaders. Sadly, I was mistaken.

As many of you may know, FDA regulations forbid drug companies from promoting off label use of previously approved drugs. Not surprisingly, drug companies were able to find loop holes in the regulations and off-label drug promotion reached unprecedented levels in the early 2000s. In response, the agency embarked on an aggressive, unrelenting campaign to combat off label drug promotion by drug manufacturers. This effectively changed the way in which pharmaceutical sales representatives interacted with physicians in the past few years. No longer would there be unsolicited gifts, lavish pizza lunches for office personnel or tickets to local sporting events. Neither the drug makers nor physicians were happy about the rule changes but the revised guidelines helped to lessen off label promotion of previously approved drugs. That said, it came as something of shock late last year, when FDA officials proposed a new set of guidelines that would ease the restrictions on off label drug promotion.

The new rules would allow drug makers to supply physicians with copies of published research reports describing off label uses of drugs that were previously approved for other therapeutic indication. As you might have guessed, the drug companies are ecstatic with the new guidelines. Who needs pens, mugs or pizza when you can simply hand a physician a reprint of article that show that off label use of an approved drug can treat potentially life threatening medical conditions.  What an ingenious way to boost sales of extant drugs for new indications without having to spend larges of money trying to win regulatory approval for them. While this would be a financial boon to the pharmaceutical industry, I don’t think it would be in the best interest of patients who may be prescribed a drug that hasn’t undergone the rigorous scrutiny of controlled, human clinical trials.

Many congressional democrats and drug industry critics opposed the guidelines when they were first proposed last year. But, like many other times over the past eight years, the Bush administration prevailed. Today, the agency announced (with little fanfare) that the new off label drug use guidelines would go into effect—one week before Barack Obama is inaugurated as President. 

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

 

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Targanta Therapeutics, a Cambridge, MA-based biopharmaceutical company, announced that it will lay off 85 of its 115 employees or almost 75% of its workforce. The news follows the FDA’s rejection of its application for oritavancin, an antibiotic it is developing to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and other antibiotic resistant bacteria. The agency wants Targanta to conduct another Phase III clinical trial to further assess of oritavancin’s safety and efficacy.

The company estimates that the new clinical trial will cost about $20 million. Targanta CEO Mark Leuchtenberger said “We are no longer a pre-commercial company. We are back to being a Phase three company, and that requires us to right-size and to streamline our operations.”

Things are not going well for companies in the antibacterial drug discovery and development space. Late last month, FDA rejected Swiss-based Arpida’s NDA for iclaprim an antibiotic it was developing to treat complicated skin and soft infections caused by MRSA. Shortly after receiving the news, Arpida layed off roughly 72% of its employees and is down to about 30 employees like Targanta.

It is unfortunate that big pharma decided to abandon antibacterial discovery and development research about eight years ago. Consequently, development of  new, much-needed antibiotics has been relegated to financially-strapped, small biopharmaceutical companies whose likelihood of success is questionable.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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Sometimes reality is stranger then fiction. The Pharmalot blog reported today that US Senator Sherrod Brown, an Ohio Democrat, is nominating several candidates for the post and one of them is Peter Rost, MD!

For those of you who may not know Dr. Rost, he is a former Pfizer marketing executive who blew the whistle on some alleged marketing and sales violations at the drug maker. His court case is working its way up the judicial ladder and Dr. Rost apparently has the upper hand so far.

Pfizer fired Dr. Rost “for cause” after a raucous, public skirmish that went on for almost 2 years. After he left Pfizer, he wrote a book, worked for the Huffington Post and started his own blog, which currently has a post about his candidacy for the FDA Commissioner job. 

I first met Peter when he was still at Pfizer and I was organizing a meeting on drug reimportation (he is an ardent supporter). He agreed to talk at the meeting but unfortunately the conference was canceled for one reason or another. I have no doubt that he has the medical credentials and business acumen to handle the job. The one thing that worries me is his penchant for self promotion—something that is not a desirable trait in  an FDA Commissioner.

Time will tell. Personally, I would like to see Dr David Kessler come back and run the agency—another whistleblower (at UCSF) who ran the agency from 1990-1997 and did an outstanding job. The way things are going at FDA these days maybe being a whistleblower ought to be one of the requirement for the job!

Until next time…

Good Luck and Good Job Hunting

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U.S. regulators have delayed a decision on approval of an antibiotic from Johnson & Johnson and Basilea saying they need further audits of clinical sites, the two companies said on Wednesday.

Ceftobiprole, a broad-based spectrum antibiotic targeted mainly against infections caused by methicillin-resistant Staphylococcus aureus (MRSA), is Basilea's lead product and the news hit the Swiss biotech shares, which plummeted 27 percent.

In a so-called complete response letter on the drug's approval application, for complicated skin and skin structure infections, the Food and Drug Administration (FDA) said it was unable to review the clinical data submitted with the NDA until issues of data integrity had been resolved. The FDA has asked J&J to conduct additional audit work of clinical investigator sites and to address specific questions related to site monitoring."

Ceftobiprole is approved in Canada and Switzerland and has been recommended for approval in the European Union. A new application in the United States is planned within a year.

Late last week, FDA rejected an NDA for another antibiotic, iclaprim, being developed by Arpida, another Swiss company. It has been a bad two weeks at FDA for approval of new antibiotics—drugs that we desperately need.

Until next time….

Happy Thanksgiving

 

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The Pharmalot blog reported today that this coming Friday, the US Federal Trade Commission (FTC) will conduct a workshop on the issue of follow-on biologics. The roundtable will apparently be organized into five panels to discuss: 1) the price and market share effect of entry by both biosimilar and biogeneric drugs, 2) the likely competitive effects of reference product regulatory exclusivity, 3) biotechnology patent issues, 4) the likely competitive effects of follow-on biologic regulatory incentives, and 5) the patent resolution process.

The first thing that comes to mind is “beating a dead horse” (euphemistically of course). Call me crazy but these very issues have been bandied about and discussed ad nauseum and  for the past decade or so. I am not sure what new revelations will come to light at this Friday’s FTC roundtable meeting. 

Here’s a thought. Maybe industry representatives, FDA regulators and the insurance companies ought to ask the European Union how they were able to craft their version of a regulatory pathway for approval of these products way back in 2004. Nah…let’s let the lobbyist duke it out and see which side wins!

Until next time…

Good Luck and Good Job Hunting

 

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An article in today’s New York Times reports that several FDA scientists have accused the agency of granting market approval to several unsafe medical devices. According to published reports, “the House Committee on Energy and Commerce will investigate the accusations, first aired when eight agency scientists wrote a private letter in May to FDA commissioner Andrew von Eschenbach.”

Unfortunately, the allegations made by the eight scientists against the agency are nothing new. Frequently, agency managers (and sometimes political appointees) lean toward approving drugs or devices when the data pertaining to efficacy and safety are equivocal.

My sources at FDA suggest that this is what happened with approval of Merck’s ill-fated pain medication Vioxx.

Recently, there has been a spate of safety claims made against medical devices manufacturers. This is not surprising because the regulatory hurdles for marketing approval of devices are much lower for devices as compared with drugs and the medical devices and diagnostics business is the fastest growing sector in the life sciences. For an overview of the medical devices and diagnostics industry please read my recent article published in Science Careers.

Hopefully, new leadership at the agency will turn things around!!!!!!!

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!

.

 

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Just when the medical device industry is gaining steam and poised to challenge pharma and biotech companies for market share and profits, some lawmakers have begun to question the medical devices industry’s direct-to-consumer (DTC) advertising practices. Last year, the medical device industry spent about $193 million for DTC advertising on television and the Internet—a mere fraction of what was spent on DTC consumer advertising for prescription drugs sold by pharmaceutical and biotechnology companies.

One reason given by lawmakers to justify its current scrutiny of medical devices DTC advertising practices is that “medical devices can have more of an impact on a patient’s well-being than a drug because devices often require surgery to implant and may remain inside the body for years.” However, in response, a representative from the Advanced Medical Technology Association, a medical devices trade group said, “While an advertisement may stimulate a patient to ask a doctor about device, the process of receiving one involves a discussion of its benefits and risks.” He went on to say “You may take a pill because it doesn’t involve very much. But you don’t undergo surgery unless you think you have a serious need for it.” 

Another reason cited by Herb Kohl, a Democrat from Wisconsin is “The medical device industry is just beginning to get into the game.” Yes, Mr Kohl’s assertion is absolutely correct. Unlike most pharma and biotechnology companies, which have engaged in unregulated DTC advertising for the past 10 years or so—and literally made billions— the medical devices industry was slow to recognize that DTC advertising could be used to effectively hawk its products. I guess the thought here is: “to head ‘em off at the pass!”

The current call for an investigation into the DTC practices of some medical devices companies raises several interesting questions. First, is the investigation simply a red herring to distract FDA from crafting new regulations to rein in and more tightly control DTC advertising by pharmaceutical and biotechnology companies? (While FDA has recently revised some of its DTC advertising guidelines, the changes are still not rigorous enough). Second, could the call for increased scrutiny of the medical devices industry simply be an attempt (by pharma and biotech lobbyists) to stifle the recent, explosive growth of the medical devices industry?  Finally, why are lawmakers rather than the agency (which oversees the device industry) investigating the DTC advertising practices of medical devices companies?

On a personal note, I support tighter regulations and increased scrutiny of the DTC advertising practices for all  life sciences companies. Although DTC ads are directly aimed at consumers, their real purpose is to influence prescribing practices of physicians by inducing patients to ask questions about whether or not the drugs or devices that they “saw on TV” are appropriate for them. That said, I believe that it is up to FDA to insure that all DTC ads are fairly balanced (risks vs. benefits) and medically accurate before they are viewed by the American public.

Until next time…

 

Good Luck and Good Job Hunting!!!!!!!!!!!

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The Pharmalot blog reported today that Merck received approval from the US Food and Drug Administration to use Gardasil to prevent vaginal and vulval cancer in addition to cervical cancer.

Of late, Gardasil has been a lightening rod for controversy—mostly because of Merck’s unrelenting marketing campaigns (and the behind-the-scenes lobbying for the vaccine to be placed on the US mandatory vaccination list)  coupled with the Christian right’s moral machinations about premarital sex and sexually transmitted diseases in general. Also, let’s not forget the brouhaha surrounding FDA’s decision to delay approval of GlaxoSmithKline’s competing cervical cancer vaccine called Cervarix. Finally, about a month ago, there was study published in the New England Journal of Medicine questioning the cost effectiveness of Gardasil vaccination of women after the age of 18.

Regardless of your moral, ethical or business concerns about Gardasil, the bottom line is this: girls/women vaccinated with Gardasil are much less likely to develop cervical cancer as compared with those who are not vaccinated.

As I have mentioned before, all approved and marketed drugs have side effects and possible safety/tolerability issues. More importantly, the decision to approve a particular drug is always based on a careful risks/benefits assessment by government healthcare regulators. Whether or not a person uses a drug or vaccine is ultimately a personal choice. With the exception of mandatory childhood vaccines (children can be exempted for moral or religious reasons), every American has the right to decide whether or not to use a medication or undergo a treatment recommend by a healthcare professional. Based on everything that I have read about Gardasil, it appears to be a safe and effective vaccine to prevent cervical cancer. When FDA finally approves Cervarix (probably sometime in late 2009), it will offer women who may have concerns about Gardasil with an alternate vaccine to protect them against developing cervical cancer.

The funny thing about the Gardasil firestorm is that cervical cancer isn’t a major healthcare problem in the US. This is because a majority of American women undergo annual routine gynecological examinations (that include pap smears, the current gold standard for cervical cancer detection). In contrast, cervical cancer is a major healthcare problem and economic concern in Asia, most notably in China and India. This begs the question—why are Merck and GSK so intent on selling their cervical cancer vaccines in the US? Put simply, there is still much more money to be made in the US than in Asia. Look for approval of Gardasil and Cervarix in China and India when the middle class of both countries reach a critical mass.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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I previously posted a piece on BioJobBlog about direct-to-consumer advertising that is used by many pharma and biotech companies to induce people who see the ads to ask their physicians about a “ drug that they heard about on TV.” John Heubusch who runs Writing Frontier.com, read the post and pointed me in the direction of a piece that he wrote on the same topic. His slant on the topic is different than mine but we both reach similar conclusions—DTC advertising needs to be better regulated by FDA.

Until next time… 

Good Luck and Good Job Hunting!!!!

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Just when I thought the absurdities surrounding the American follow-on biologics debate couldn’t get any sillier, the US Federal Trade Commission (FTC) announced today that it would sponsor public workshops and round table discussion to learn more about the impact of follow-on biologics on American competitiveness, regulatory policies and healthcare costs.

I am not certain what role the FTC has in the follow-on biologics debate (as far as I am concerned, it shouldn’t have much of one) but what new information does the FTC think that it is going to get that other more relevant government agencies like FDA or the US Congress don’t already have about follow-on biologics? After all, the debate to formulate an approval pathway for follow-on biologics in the US has gone on for almost 10 years now. How ineffectual and ineffective can the US government and its agencies be (rhetorical question)?

 

As far as I can ascertain, the main reason why follow-on biologics are not already being sold in the US are the never-ending efforts of power, well-funded lobby organizations like BIO and PhRMA. The data are incontrovertible: 1) the cost of branded drugs is out of reach for many Americans, 2) access to potentially life-saving drugs and treatments is hindered by restrictive drug formularies and onerous insurance co-pays and 3) many local and state governments and large, multi-national corporations can no longer provide adequate healthcare coverage for their employees because of out-of-control medical costs and expenditures.

 

In my opinion, the irony of the US follow-on biologics brouhaha is that it is putting American companies at a competitive disadvantage in the biosimilar/follow-on biologics space. Selling profitable, cheaper generic versions of blockbuster drugs is no longer a dream but a reality in countries like China and India whose middle class has finally come of age. True, the American pharmaceutical/biotech market is still the largest in the world—but will it still be the largest 10 years from now? Only time (and Asia) will tell.

 

Until next time….

 

Good Luck and Good Job Hunting!!!!!!!!

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After beating Wall Street expectations and disclosing positive results from an osteoporosis (densomab) clinical trial, Amgen was ordered by the US Food and Drug Administration (FDA) yesterday to change the labels for its EPO drugs (Epogen and Aranesp) that will likely further restrict their use in treating patients with cancer.

The label changes ordered by FDA represent the first time that the agency has invoked its power to change prescribing information for drugs that it previously approved. In the past, FDA could only negotiate with drug manufacturers about changes to labels and prescribing information. In my opinion, it’s about time that FDA has been empowered to unilaterally order these types of changes. I have long contended that negotiations between the agency and drug makers about labeling and prescribing information is not in the best interests of Americans who use prescription drugs. To that end, it was negotiations between FDA and Merck about whether the serious cardiovascular risks associated Vioxx should appear on the Vioxx label (they didn’t) that lead to the misuse, safety problems and ultimate recall of the drug.

While the ordered label changes are not good news for Amgen and its partner Johnson and Johnson which sells Procrit (EPO manufactured by Amgen and sold by J&J), they are in the best interests of all Americans who use these drugs to treat anemia caused by cancer chemotherapy and kidney disease.

Until next time….

Good Luck and Good Job Hunting (avoid A Thousand Oaks, CA)!!!!!!!!!!

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A post at the Pharmalot blog said that the US FDA and the Centers for Disease Control issued a statement today indicating, that after reviewing side effect reports, Merck’s anti-HPV (cervical cancer) vaccine Gardasil is safe and effective, and its benefits continue to outweigh its risks.

According to the statement, the joint agency review determined that 94 percent of  all side effects reported after Gardasil vaccination were not serious. The most commonly reported adverse events fainting, pain at the injection site, headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents, the agencies noted.

Although there have been 20 reported deaths following vaccination, there was no common pattern or tend that would suggest they were caused by the vaccine itself. The statement went on to say that in cases where autopsy, death certificate and medical records were available, the cause of death was explained by factors other than the vaccine.

The statement was likely issued in response to highly publicized and widely circulated adverse events reports issued by the ultraconservative Judicial Watch which is morally opposed to HPV vaccination. It is extremely unfortunate that a small but vocal group of conservative Christians are willing to risk the health of their daughters because they are morally opposed to premarital sex and birth control. 

Until next time….

Good Luck and Good Job Hunting!!!

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Richmond Va-based INSMED, a US-based follow-on biologics manufacturer, posted a press release on its website entitled: “Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company” that reports on the results from a Phase I clinical trial that demonstrated that it lead product INS-19 was bioequivalent to Amgen’s Neupogen^(R) (recombinant G-CSF) in stimulating human white blood cell production. 

, Dr. Geoffrey Allan, President and CEO of Insmed said  "These results are very exciting, as they represent Insmed's ability to replicate a protein product, to bring that product rapidly through the clinic and to demonstrate clear bioequivalence to the innovator drug," said "To our knowledge, we are the first U.S. company to report human bioequivalence data for a follow-on biologic product, validating the idea that follow-on biologics can be a scientific reality in the U.S. and that Insmed is well positioned to be a leader in the field. “ The company has requested a meeting with FDA to discuss the design of a Phase III human clinical trial for INS-19.

I am not sure why INSMED is so excited about its results. Sandoz essentially accomplished the same feat with Omnitrope, its biosimilar version of recombinant human growth hormone (HGH)and it took a law suit and a loophole in the approval process for growth hormones for FDA to allow it to be sold in the US. In my opinion, until legislation is passed that provides a clearly defined legal pathway for approval of follow-on biologics I suspect that INS-19 will suffer the same fate (or perhaps worse) than Omnitrope. Bioequivalence is only legal defined for and relevant for approval of small molecule NOT BIOLOGICS when seeking expedited approval for generic versions of branded products. That said, I want to tip my hat to INSMED for its willingness to take a lead role in the fight to get follow-on biologics approved in the US. Finally, there is nothing like an edgy press release and a few bloggers to bring an issue that is rapidly losing momentum back to the forefront.

Kudos to INSMED!!!!!!

Until next time….

Good Luck and Good Job Hunting!!!!!!

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In an attempt to assuage the jitters and financial concerns of investors who own stock in pharmaceutical, biotechnology and medical device companies, the US Food and Drug Administration announced yesterday that it will be change the format of the letter received by companies whose products are not ready for approval.

In the old days (at least until yesterday), when the agency determined that drugs were not suitable for sale, it would send companies a so-called non-approval letter. This letter was designed to inform drug and device makers that their products had issues that needed to be resolved before the agency will approve them. Apparently, (at least according to drug and device manufacturers), receipt of non-approval letters by companies signaled to investors that the product in question would never, under any circumstances, be approved by FDA. This urban legend was born because most companies that receive non-approvable letters decide against investing more time and money into products that FDA has deemed “unapprovable” i.e. there isn’t enough of a financial inducement or upside to continue further development.

Now, when new products are not up to snuff, companies will receive something called a “complete response letter.” According to the agency, the new letters will describe what is missing from a new drug or device application and, when, appropriate, offer advice on how to fix or address the problem(s). However, because contents of FDA letters are not released to the public, investors may now be less informed about the prospects of a new drug than in the past when the agency was able to send “approvable” or “non-approval” letters to companies.  “While this new plan may provide more detailed information to a company regarding issues that need to be addressed, investors will likely be kept in the dark on the true status of a drug’s approvability” said a pharmaceutical analyst after learning about the format changes. He went on to say “Investors will no longer know whether a drug is truly dead in the eyes of FDA.”

In my opinion, this is another example of FDA cow towing to the whims and wishes of industry. Whether you call it, a “non-approvable” or “complete response letter”, it still means the same thing—the drug or device is not ready for prime time! I don’t think that the change in semantics will do anything to assuage concerns of jittery investors. What it WILL do is force investors to rely solely on the honesty of the management teams that receives these letters—Oy!

I think that FDA ought to stick to the business of evaluating the safety and efficacy of drugs and be less concerned with the political and economic needs of the drug and device industries. Finally, it would be prudent for FDA to allow appropriately trained professionals to provide psychotherapy to all of the frightened and jittery investors out there!!

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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The old adage “When it rains, it pours” is particular apt for the bad news that has plagued the once venerable Merck & Co for the past five years. First, there was the Vioxx scandal, followed in short order by the Vytorin and Singulair messes and now it appears that the company’s new anti-cervical cancer vaccine, Gardasil, may have —pardon the expression — a few “warts” on it. 

Last night on my local nightly news, there was a brief report about emerging safety issues with Gardasil. According to the report, adverse events ranging from “massive wart outbreaks to seizures and paralysis” have been reported for the anti-HPV vaccine. Since its approval in 2006, over 8,000 adverse event reports (the total number of people vaccinated was not disclosed) and 18 alleged deaths have been reported for Gardasil (although none of the deaths has been directly linked to Gardasil vaccination). This news comes on the heels of a recent Wall Street analyst’s report indicating that sales of Gardasil are much lower than expected. It appears that the vaccine, once considered by Merck insiders as the new blockbuster that could save the flagging drug maker, may, after all, be relegated to specialty drug status.

As many of you may know, GlaxoSmithKline (GSK) is seeking US approval for its anti-cervical cancer vaccine called Cervarix. Although Merck beat GSK to market, Cervarix has undergone more clinical testing and allegedly may have a better safety and tolerability profile than Gardasil (only the regulatory agencies know for sure). Nevertheless, it is not clear whether GSK will benefit or be injured by the negative publicity that Gardasil is receiving. As I mentioned in a previous post, the US Food and Drug Administration (FDA) recently delayed Cervarix’s approval pending submission of additional data that the agency requested from GSK.

Before anybody puts a nail in Gardasil’s coffin, it is important to point out who started the recent firestorm about the vaccine. It was none other than the conservative-funded public interest group Judicial Watch. It is no secret that this group advocates abstinence over condom usage and other methods to prevent sexually transmitted diseases. Further,  I suspect that a majority of Judicial Watch’s members don’t believe sex education or pre-marital sex for that matter. Finally, I have no doubt that Judicial Watch received some support (financial, spiritual or otherwise) from the anti-vaccination lobby that is unfortunately gaining strength in the US and elsewhere.

From a scientific standpoint, it is difficult to get a real measure of the safety of a vaccine until it has been widely used by large numbers of people. Although pivotal Phase III trials are required for all vaccine approvals, the number of people studied in these trials (sometimes in the tens of thousands) is not sufficient to predict all possible safety problems that may emerge when the vaccine gains widespread use. For this reason, regulatory agencies typically require vaccine manufacturers to conduct mandatory post marketing Phase IV clinical trials that are designed to address the seriousness of any possible safety concerns that may have emerged after a vaccine has been on the market for several years. Because all vaccine makers know this, it is still not clear to me why Merck, a company which has been in the vaccine business for a very long time, embarked on its failed lobbying campaign to get Gardasil on the mandatory US vaccination schedule shortly after it was approved. 

As I have said in the past, ALL pharmaceutical and biotechnology drugs have side effects and their occurrence and severity varies from person to person. Generally speaking, most drugs are approved by regulatory agencies because their potential benefits outweigh real or presumed safety risks. That said, the question facing all parents who have daughters is: Does protection against cervical cancer outweigh any adverse events or potential safety risks associated with Gardasil or Cervarix vaccination? It is a tough question but one that my wife and I and others will have to answer for our daughters!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station, NJ)!!!!!!!!!

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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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The regulatory problems at Wyeth continue. The US Food and Drug Agency announced that it issued an approvable letter for Tygacil (Wyeth’s tetracycline-like antibiotic) to treat community acquired pneumonia (CAP). Apparently, FDA regulators want more data on the effectiveness and safety of Tygacil in severe cases of CAP and additional information on possible liver toxicity.

Tygacil, an intravenously administered antibiotic, won FDA approval in 2005 to treat adults with complicated intra-abdominal infections and complicated skin and skin-structure infections. Tygacil had about $138 million in sales last year; falling far short of the projected $500-$800 million in annual sales that it was expected to yield when it was first brought to market. If Wyeth gains approval for CAP, expect Tygacil sales to soar.

In other regulatory news, FDA granted Wyeth “fast-track approval” for a new version of its market-leading pediatric pneumococcal vaccine called Prevnar. The new 13-valent formulation will provide protection against 13 different pneumococcal serotypes. The older version only provided protection against 7 serotypes. Wyeth hopes to complete its filing for pediatric use of the new Prevnar vaccine in early 2009. Prevnar is Wyeth’s second-leading product with sales of about $2.5 billion in 2007.  

The new Prevnar vaccine will likely go head-to-head with GlaxoSmithKline’s new 10-valent pneumococcal vaccine  called Synflorix^Tm which is in late stage clinical development and is currently being reviewed for marketing approval in the EU. Unlike Wyeth’s vaccine, Synflorix^Tm  was found to be effective in protecting against otitis media (ear infections) caused by Haemophilus influenzae.

Until next time,

Good Luck and Good Job Hunting (avoid Collegeville, PA)!!!!!!!!

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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. The ad in question deals with promotion of the use of a cardiac stent called Cypher that is manufactured by the company. The television ad is the first ever to market a medical device. Nevertheless, according to an article published in this week’s New England Journal of Medicine, the ad overstates the benefits of the stent without mentioning possible adverse effects that can include heart attack and stroke.

The current brouhaha is nothing new in the ongoing battle between drug manufacturer (and now, medical device companies) and regulators over DTC advertising. As some of you may know, the US is one of a few industrialized countries in the world that allows DTC advertising.  Further, DTC ads don’t require FDA review or approval before they are aired or printed–although in some instances, companies do request FDA review. 

Because of growing problems with DTC ads (especially television spots), there is mounting pressure on FDA to limit consumer medical advertising or, at the very least, increase regulatory oversight of it. To that end, on Friday, an FDA advisory panel will convene to discuss whether television ads for prescription medications ought to include a statement encouraging consumers to report any adverse side effects via a toll free number to the agency. At present, this type of disclaimer is only required for DTC print ads.

For those of you who don’t know, FDA has (by law) a post marketing surveillance network in place to allow consumers to report any side effects (big or small) that they may experience after taking prescription or over the counter medications. Further, companies are required by FDA regulations to immediately report any and all side effects associated with their products.

Of interest, in a hearing last week on drug advertising (being conducted by the House Energy and Commerce Committee), several drug company representatives in attendance were asked whether or not they would support a toll free number on television ads to encourage viewers to report adverse side effects. Surprisingly (perhaps not) they could or would not directly answer the question. According to John D. Dingell, chair of the committee and advocate of greater regulatory oversight of DTC advertising, “Some ads appear to be misleading and others appear to be downright deceptive.” Imagine that!

What is particularly disturbing about the DTC controversy is that government officials and legislators are frequently incredulous when they learn about DTC advertising abuses. As I have stated time and time again, there are larges sums of money at stake here. This coupled, with little or no regulation, and mounting pressures to keep company stock price shares high, is a sure recipe for disaster (as we have begun to witness over the past 5 years or more). In my opinion, there is only a single solution to the problem–craft more stringent regulations and greater FDA oversight for DTC advertising. Asking drug and medical devices companies to regulate themselves in any area is tantamount to allowing a fox to live in a hen house—the pickings are easy and only the fox gets fat!

Until next time….

Good Luck and Good Job Hunting!!!!!

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In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approval in the EU. Of the five, two are generic versions of recombinant growth hormone (rHGH)–Omnitrope (Sandoz) and Valtropin (Biopartners). The remaining three are “knock off” versions of erythropoietin alpha–Binocrit (Sandoz), Epoetin alpha Hexal (Hexal) and Abseamed (Medice Arneimittel Putter).

There is no doubt, at this point, that Europe is leading the way in the biosimilar space. However, it is important to point out that a variety of biosimilars, developed by Indian generic manufacturers and others, are already being sold in less- regulated Asian markets (see Table 1). Unfortunately, political issues and the fierce struggle between innovator

Table 1. Biosimilar Manufacturers and Their Products

Company	Launched Biosimilars	In the Pipeline
Barr                                                          (www.barr.com)	EPO scheduled for launch in Eastern Europe	G-CSF (Filgastrim), Insulin, and HGH
Biocon                                          (www.bioconinc.com)	Insugen (Insulin in India and China), Erypro (EPO) G-CSF, Nimotruzmab, BIOMAb EGFR (cancer)	Insulin, glargine and HGH
Biopartners                             (www.biopartners.ch)	Valtropin (rHGH)	Alpheon (INF-α) and EPO
Cipla                                                   (www.cipla.com)	None	Autoimmune, cancer and cardiovascular
Dr. Reddy’s Labs                       (www.drreddys.com)	G-CSF (Filgastrim)	Nine (9) development programs
Glenmark                  (www.glenmarkpharma.com)	None	GBR 500 (mAb for MS), GBR600 (antithrombotic) and mAbs for adhesion molecular inhibitors
Intas Biopharma (www.intasbiopharma.com)	Neukine (G-CSF), Erykine (EPO) and Intalfa (INF-alpha2b)	Six (6) development programs
Prolong Pharmaceuticals (www.prolongpharmaceuticals.com)	None	PEG-EPO and other PEGylated proteins
Ranbaxy (www.ranbaxy.com)	Nugraf (Filgrastim), Macrogen (Molgramostim from Zenotech)	mAbs in oncology and neurology
Sandoz (www.sandoz.com)	Omnitrope (HGH), Binocrit (EPO)	Six (6) development programs including G-CSF (Filgrastim)
Shanta Biotechnics                              (www.shantabio.com)	Shaferon (INF-alpha2b, Shankinase (streptokinase) and Shanpoietin (EPO)	mAbs and PEGylated therapeutic proteins
Stada                                               (www.stada.de)	EPO-Zeta (approved)	Filgrastim
Teva                                           (www.tevapharma.com)	G-CSF (Filagstrim),Teva-Tropin (HGH), INF-alpha2b	Insulin, EPO and interleukins
Wockhardt                             (www.wockhardt.com)	Wepo (EPO), Wosulin (insulin) INF-alpha2b, G-CSF	Insulin Glargine

biotechnology companies and generic manufacturers have delayed development of legislation for regulatory approval of follow-on biologics (American lingo for biosimilars) in the US. Further, and perhaps more perplexing, the FDA has been reluctant to issue any guidance on the topic. However, rising drug costs and increasing expenditures on biologics (both by Medicare and private insurers) have left American lawmakers with no choice but to craft legislation for approval of follow-on biologics.

In the first half of 2007 alone, three different bills were proposed to craft a statutory pathway for the approval of follow-on biologics under the Biologic License Application (BLA). The first of these bills–The Access to Life-Saving Medicine Act– was introduced into Congress by Representative Henry Waxman (CA) and into Senate by Senator Chuck Schumer (NY) in February. The second bill–the Patent Protection and Innovative Biologic Medicine Act –was introduced in Congress in April by Representative Jay Inslee (WA). Neither bill made any progress. This is because the Access to Life-Saving Medicine Act was considered to be heavily pro-follow-on whereas the Patent Protection and Innovative Biologic Medicine Act was deemed to favor innovator companies and did not provide any financial incentives for follow-on manufacturers.

A compromise was reached by both Republican and Democrat Senators and the Biologics Price Protection and Innovation Act was approved by the Senate on June 27.  It proposes 12 years of market exclusivity for the patent holders but also one year of exclusivity to the first follow-on biologic to be approved as interchangeable with the reference product.  I previously aired my views on the proposed legislation. For a more in depth analysis of the issues and the bills, please read this.

Recently, there was an important new regulatory development in the European biosimilar landscape. Sandoz’s EPO, Binocrit, received the same nonproprietary name (INN) as Amgen’s original erythropoietin alpha (Epogen in the US, Eprex in Europe).This was a big win for the biosimilar industry because the INN debate had been raging in the EU for the past several years. Innovator companies wanted biosimilars to have different INN than their products whereas biosimilar manufacturers were lobbying for identical INN designation. An identical INN designation allows for  interchangeability of medicines. The fact that EMEA granted Binocrit the same INN number as Eprex, means that the agency views the two products as biologically-equivalent and interchangeable. This paves the way for EU pharmacists to freely substitute Binocrit for the more expensive Eprex. Also, it sends a message to US lawmakers and FDA that the EU considers certain biosimilars as interchangeable with their innovator counterparts. As you may have guessed, the issue of interchangeability is being hotly debated and contested by advocates on both sides of the follow-on biologics fence.

The US is clearly dragging its feet in the follow-on biologics arena. The prime driver of this inertia is the imagined loss of revenue that many innovator companies fear will occur if the US ultimately divines a regulatory approval pathway for follow-on biologics. That said, with Europe and India leading the charge into Asia, it looks as though the US is going to loss a substantial amount of money (not to mention market share) anyway.

With regard to biosimilars in the US, it is no longer a question of “if” but “when.” That said, I think that the one seminal issue that needs to be addressed is what to call these things in the US?  In my opinion, the European moniker, biosimilar, is particularly apt and appropriate for this new class of medicines. Unfortunately, we Americans don’t like to play second fiddle to anybody, especially the Europeans. With this in mind, I have no doubt that they WILL NOT be called biosimilars in the US. Whatever they are called, don’t be surprised to find them your pharmacist’s shelves in the next couple f years!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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As I mentioned in previous posts, things are simply not going Merck’s way. Merck has been battered in the past several months by the Singular flap, precipitous drops in Vytorin and Zetia sales and, most recently, FDA’s rejection of its follow-up Cordaptive anti-cholesterol drug. This has left the drug maker with little choice but to cut an additional 1,200 jobs from its rapidly shrinking US sales force.

The cuts, announced yesterday, are in addition to a companywide reorganization that began in 2005 which resulted in the elimination of approximately 8,100 positions. As of last December, Merck had 59,800 employees worldwide—soon to be 58,600 give or take a few employees!

Until next time….

Good Luck and Good Job Hunting???????

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The Food and Drug Administration (FDA) announced today that it wants to hire 1,300 biologists, chemists, medical officers and others over the next several months. The agency currently employs more than 10,000 people and wants to add 600 new employees and backfill more than 700 that have been vacant by October. The new hires will triple the number hired from 2005 to 2007. Roughly 30% of all regular FDA staffers and approximately half of FDA managers are already eligible to retire.

An FDA spokesperson said that 400 of the new jobs will be related to drug application review and another 150 will be hired as inspectors to inspect drugs, foods and other related items. The agency will rely on user fees from drug companies to pay for all drug review jobs and about 100 other positions. The rest will come from the funds that were recently appropriated by Congress.

In addition to drug reviewers and inspectors, FDA is seeking consumer safety officers, nurse consultants, statisticians, epidemiologists, pharmacologists, pharmacists and veterinarians. Most of the positions are in the Washington D.C area but some are overseas and in other parts of the US.

This is one of the largest hiring initiatives in FDA’s history. It’s about time that Congress realized that the agency has been seriously under funded and understaffed ever since Bush was elected in 2001. I suspect that the impetus for the additional funding and hiring initiative has a lot to do with the beating that the agency has taken over the past few years. As we all know, FDA has been blasted by consumer advocates and lawmakers for lax oversight and inefficiency.

I can’t recall whether I said this before, but FDA is a great place “to be from”. Many of my colleagues who worked at FDA for three or more years are now highly paid regulatory consultants charging the companies that hire them about $3,000 to $5,000 per day. That said, as a bit of career advice; opportunity is knocking—don’t dither and wait too long before you apply.

Until next time….

Good Luck and Good Job Hunting (at FDA)!!!!!!!!!!

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It seems like nothing is going right for Merck these days. On Monday, the US Food and Drug Administration (FDA) issued a “not approvable”–aka a rejection letter–for Merck’s new cholesterol drug called Cordaptive or MK-0524A. The highly-touted drug, which Merck executives hoped would replace Merck’s blockbuster cholesterol drug, Zocor (which lost patent protection a couple of years ago), can both lower LDL (bad) and raise HDL (good) cholesterol. Although experts believe that these properties should benefit people with high cholesterol, the results from recent clinical trials suggest that drugs that raise LDL and lower HDL cholesterol may have safety problems.

Cordaptive consists of an extended-release form of niacin (a B vitamin) and another agent that inhibits a niacin side effect called flushing — redness, burning and tingling of the face. Niacin has been used to control cholesterol for decades. Abbott Laboratories already sells an extended-release form of niacin called Niaspan.

Despite positive results from recent clinical trials and pending approval by the European Union, the agency rejected Merck’s NDA. Regulators also rejected Cordaptive as a brand name. It is likely that FDA is scrutinizing and proceeding cautiously with new cholesterol medications because of the recent flap over Zetia and Vytorin (which are co-marketed and sold by Merck and Schering Plough). As you may recall, both companies have been accused of trying to protect sales of the two drugs by delaying results of a study that showed Vytorin worked no better than Zocor, which is much cheaper.  Merck’s stock price dropped about 5% yesterday after the company announced that it received a not approvable letter from FDA.

Although MK-0524A may ultimately reach the US market, I wouldn’t count on it anytime soon. Merck has seriously tarnished its reputation with FDA because of the Vioxx, Vytorin and Singular controversies. The old adage, “You reap what you sow” is particularly apt in this instance. Look for more “asset reallocation” moves in Rahway.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

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After weathering the Vioxx storm for the past three years, Merck again finds itself in choppy and unchartered waters. Still reeling from the Vytorin flap that erupted two months ago, there are new allegations that its blockbuster allergy and asthma medicine, Singulair, may be linked to suicide. The US Food and Drug administration (FDA) was quick (this time) to announce that it is launching an investigation into reports that suggest that Singulair may cause patients taking the medication to commit suicide. Merck received approval for Singulair in 1998 and it had sales of $4.3 billion in 2007.

There are several reasons why FDA quickly alerted the American public to its investigation into Singulair. First, FDA has been relentlessly chastised in recent months by Congress for not notifying Americans early enough in drug safety investigations. Historically, FDA has waited until the end of an investigation (rather than the beginning) before alerting the public about possible drug safety issues. Second, the agency was well aware of emerging and ongoing safety issues with Singulair. For example, over the last year, FDA regulators asked Merck to update Singulair’s label four times. These changes included information on side effects such as tremors, anxiousness, depression and suicidal ideation.

As part of its current investigation, FDA requested that  Merck “dig deeper into its clinical data on Singulair for any evidence of possible links to suicide.” Merck quickly responded and noted that none of the 11,000 patients enrolled in 40 Singular clinical trials had committed suicide. Of course this doesn’t mean that people taking Singulair didn’t think about committing suicide. In Merck’s defense, the company may not have thought to include a question about suicidal thoughts as part of Singulair’s clinical development program. Nevertheless, it is important to note that the safety profiles for many approved drugs are not fully realized until the drug has been on the market for several years. This is because the small numbers of patient used in the clinical trials for approval of a new medication are usually not sufficient to identify all  potential safety problems. Unforeseen  or unanticipated side effects typically begin to emerge only after a drug is used by larger numbers of people in the general population.  

For this reason, the Food Drug and Cosmetic Act requires that all companies that win approval for new medications are required to set up post marketing surveillance programs. The purpose of these programs is to report any and all side effects of approved drugs to the agency. The post marketing surveillance regulation stipulates that physicians, patients and drug manufacturers must report any side effects or adverse events to the agency. Based on the number of adverse events reports that it receives, FDA can launch an investigation to determine what regulatory actions, if any, should be taken by the drug’s manufacturer to deal with the safety problems. Possible regulatory actions include label changes, black box warnings, physician notification letters, Phase IV clinical trials and possible suspension or revocation of a drug license.

Luckily for Merck, the jury is still out (no pun intended) on Singulair. That said, the good news is that the drug safety and post marketing surveillance programs outlined in the FD&C act are working exactly the way they were designed to!

Until next time…

Good Luck and Good Job Hunting (avoid Whitehouse Station NJ)!!!!!!!!

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I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 

In my opinion, the bottom line is this: the agency is egregiously under staffed and under funded despite the fact that companies pay steep user fees for regulatory reviews. I can understand why corporate America is dissatisfied with the service that it receives from FDA. It is natural to expect good customer service after paying large sums of money to a service provider.  However, it is important to note, that the words “customer service” don’t appear any where in the Food, Drug and Cosmetic Act of 1938 (although it can possibly be implied fromPDUFA in 1992 and FDAMA in 1997).  Nevertheless, what is mentioned in the FD&C is SAFE and EFFICACIOUS pharmaceuticals, biologics and medical devices. Put simply, safe and efficacious products, not customer service, is REAL the mission of FDA.  With this in mind, the agency is legally required to do everything in its power to provide Americans with carefully scrutinized and safe medical devices, pharmaceutical and biotechnology products.

If we Americans want FDA to accomplish its REAL mission, then the agency must be sufficiently funded, adequately staffed and have strong, non-partisan leadership. Unless this occurs, FDA will continue to struggle and remain dysfunctional well into the 21^st century.

Until next time…

Good Luck and Good Job Hunting!!!!!

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Ed Silverman over at Pharmalot reported today that Health Canada, the Canadian equivalent of the FDA has beaten the FDA to the punch and issued draft guidance for follow-on biologics known in Canada as subsequent entry biologics. The Canadian regulatory agency recently posted on its website requirements for manufacturers and says it could approve products under existing regulations until laws are amended to include the new approval pathway.

If approved, a subsequent-entry biologic would have to be similar to a previously approved biologic, relying in part on publicly- available safety and efficacy data. Product interchangeability and substitutability would not be automatic, but would be decided on a case-by-case basis, according to the draft guidance. Health Canada says it plans to publish additional guidance documents on specific product classes.

A subsequent-entry biologic would not automatically be approved for all the same indications as the reference product, and data would be required to support each indication in most cases. A meeting to review the draft document is scheduled for May. The proposed Canadian legislation is very similar to that adopted by the European Union for biosimilar products (what they are called in Europe). Not surprisingly the recently proposed US legislation is markedly different than the Canadian and European legislation. Go figure!

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Basilea Pharmaceutica Ltd announced yesterday that the U.S. Food and Drug Administration issued an Approvable Letter for ceftobiprole, a first-in-class anti-MRSA broad-spectrum cephalosporin, for the treatment of complicated skin and skin structure infections including diabetic foot infections. Results from two Phase III studies involving 1600 patients with complicated skin and skin structure and diabetic foot infections showed that ceftobriprole was as effective and safe as other cephalosporin antibiotics.

The Approvable Letter indicates that the ceftobiprole application is approvable, subject to completion and assessment of clinical study site inspections; assessment of clinical and microbiological data provided but not yet reviewed; and further characterization of patients with diabetic foot infections. Ceftobiprole is currently being reviewed by regulatory authorities in Canada, the European Union and in Switzerland. The antibiotic is being co-developed and marketed with Johnson and Johnson.

Until next time…

Good Luck and Good Job Hunting!!!!!!

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FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade from 1996-2005, an average of 16.6 new drugs were approved each year. In marked contrast, there were only 11 and 12 new medications approved in 2006 and 2007, respectively.

Last year was an unusually unproductive year for the pharmaceutical and biotechnology industry. The combined sales for products approved in 2007 are projected to be less than $1.0 billion dollars–the benchmark for drugs that receives blockbuster status. Further, most or the approved drugs were similar to ones that were previously approved (so called “me too” drugs) and none will significantly improve healthcare for large numbers of patients.  Finally, only two recombinant protein drugs were approved in 2007–a level more representative of the 1980s.

Most analysts agree that it is unclear why FDA approval of new drugs has decreased over the past few years and who, if anybody (FDA and/or industry), deserves the blame for the approval drop-off. Regulatory filings for a number of new products are either expected or currently pending. To that end, it is likely that there will be more new approvals in 2008 and 2009 as compared with previous years. To learn more about the drug approval conundrum please read this article recently written by Ronald A Radar.

The rate of new approvals must increase in order for the biopharmaceutical and pharmaceutical industries to remain economically healthy and viable. Industry and the FDA must work more closely with one another to continue to insure that the American public has ready access to innovative, safe and efficacious, new biopharmaceutical and pharmaceutical products. 

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According to Johnson & Johnson, a panel of advisors for the Food and Drug Administration, in a surprise decision, supported keeping Epogen, Procrit and Aranesp from Amgen and Johnson & Johnson on the market for use in cancer patients who are anemic from chemotherapy.

The advisor panel voted 13-1 to keep Amgen's Aranesp and J&J's on the market for use with chemotherapy. The recommendation was very surprising because over the last year FDA has scrutinized the drugs because of safety concerns and recently added new warnings to the labels. Many analysts expected further recommendations for restrictions. Although the advisory panel vote is non-binding, FDA usually follows the advice of its panels when making regulatory decisions. However, it is important to note that FDA has not followed the advice of several advisory panels in the recent past.

The positive advisory panel vote is good news for J& J and Amgen because billions of dollars in revenue are at risk for the cancer indication.  I bet that J & J and Amgen executives breathed a collective sigh of relief after hearing the news!  Maybe that loud noise I heard earlier today was the popping of champagne corks at J & J corporate headquarters in New Brunswick, NJ.  

To quote Mark Twain: “The rumors of my death have been greatly exaggerated” is particularly apt for Amgen and J &J after today’s decision.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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According to a press release by IMS, a company that tracks pharmaceutical sales, growth of the US pharmaceutical market shrank from 8% in 2006 to a meager 3.8% in 2007–the slowest growth rate since 1961. Total U.S. prescription sales in 2007 only reached $286.5 billion. The 2007 slowdown in sales was attributed to:

• Loss of patent exclusivity for branded products
• Fewer new drug approvals
• Effect of Medicare Part D on annual growth
• Renewed focus on safety issues by US Food and Drug Administration

Industry officials place the blame for the slow down on FDA because fewer newer drugs were approved in 2007 as compared with years past. However, I believe that the slow down has more to do with:

• Higher prices of branded medications as compared with generic drugs
• Lack of public confidence in the pharmaceutical industry
• Increased scrutiny by regulators on direct to consumer advertising and continuing medical education (CME)
• Fewer and less innovative drugs in company pipelines

Bashing FDA is easy. The willingness of the pharmaceutical industry to assume ownership of some of its own shortcomings and missteps is substantially more difficult to do!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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Erythropoietin (EPO) is a hormone (protein) that regulates red blood cell production in humans. Back in the 1980s, scientists at a fledgling biotechnology company called Amgen determined that recombinant EPO was highly effective for treating anemia. Amgen owned the intellectual property rights to the EPO gene and decided to sell the recombinant protein encoded by EPO (called epoetin) as a treatment for anemia.EPO is known to alleviate fatigue caused by anemia by stimulating red blood cell production.

Amgen’s first EPO product, called Epogen, was approved in 1989 to treat patients suffering from anemia associated with renal failure. Procrit, Johnson and Johnson’s version of EPO (which was licensed from Amgen) was approved four years later in 1993 to treat chemotherapy-induced anemia. Aranesp, a longer acting version of EPO which is also manufactured by Amgen was approved in 2001 for anemia associated with chronic renal failure and in 2002 for chemotherapy-induced anemia in cancer patients.  All of the EPO drugs have gained blockbuster status and, over the past five years or so, the annual revenue generated by these drug is estimated to be $6.0 to $12 .0 billion.

Since their approvals, EPO, Aranesp and Procrit have been administered to tens of millions of kidney dialysis and cancer patients undergoing chemotherapy with minimal safety concerns and generally positive outcomes. However, with the looming specter of generic biologics (EPO lost patent protection in 2004) and competition from companies like Roche developing competing EPO products, Amgen stepped up its efforts to promote and sell EPO and Aranesp. This, in turn, caused EPO drugs to be used by many physicians, which ultimately resulted in additional safety warnings and a label change for all EPO products. The label change coupled with unrelenting negative publicity about Amgen’s promotion of its EPO franchise, caused its stock price to plummet and forced the company late last year to lay off 14% of its workforce.

Like other biotechnology and pharmaceutical companies, Amgen sought to find ne indications for its EPO products. To that end, there was some compelling evidence several years ago which suggested that EPOmight increase survival of cancer patients, when used with radiation and chemotherapy. The idea was that higher oxygen levels in the blood would make the radiation or chemotherapy being used to treat the patients' cancer more effective. With this in mind, several groups of investigators initiated human clinical trials to determine whether EPO treatment would benefit non-anemic cancer patients. Unfortunately, the New York Times reports that results from no fewer than eight clinical trials suggest that EPO drugs might actually promote rather than slow tumor growth and hasten the death of cancer patients.

Amgen believes that the increased trial deaths among EPO-treated patients resulted from blood clots rather than by promoting tumor progression or growth. The company contends that the amounts of EPO used in the trials exceeded what is recommended in the drug label and, at those levels, blood clots are a known common side effect. On the other hand, there is a growing body of evidence from a variety of sources which suggests that some types of human tumors express EPO receptors, which when stimulated by EPO binding, induces tumor cell proliferation. To make matters worse, when Procrit was first approved to treat chemotherapy-induced anemia, FDA regulators suggested in briefing documents that there may be a “hypothetical risk” that EPO could stimulate tumor cell growth. Nevertheless, neither FDA nor most EPO experts believe at this time that a direct link between EPO use and tumor growth has been established. Everyone agrees that more research must be conducted to verify or refute this idea.

Tomorrow, an advisory committee to FDA will consider placing further safety restrictions on the use of EPO drugs.  If they feel that blood clots were responsible for increased death among EPO-treated cancer patients then the recommendation would be relatively simple–only use the recommended modest levels of EPO to treat cancer patients as indicated on the product label.  However, if they believe that EPO directly stimulates tumor growth then even the currently recommended modest doses of the drug may be too risky to treat cancer patients. Regardless of the outcome of the tomorrow’s FDA advisory meeting, it is clear that Amgen’s flagship EPO franchise may be in serious jeopardy.

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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After an exhaustive nationwide search, FDA Commissioner Andrew von Eschenbach decided yesterday that Janet Woodcock, a career FDA staffer, was the best choice to lead the agency’s struggling Center for Drug Evaluation (CDER). For Dr. Woodcock who has been the acting head of CDER since September, this will be the second time that she was tapped to lead the center. She was previously appointed to the top CDER job in 1994 by then FDA Commissioner David Kessler (the last time FDA had any real leadership).

The inside skinny on the appointment is that she beat out Jesse Goodman for the position, another career FDA employee  who is currently the head of the agency’s Center For Biologics Evaluation and Research (CBER).  What surprises me the most about Woodcock's appointment is that after a nationwide search to find a new leader for CDER, von Eschenbach’s final choice was between two career FDA bureaucrats!  Why bring in an outsider with fresh new ideas when the best available talent in the land already works for you?

Don’t expect anything to change at the agency.  Dr. Woodcock tows the party line and is loyal to von Eschenbach (who by the way is a personal friend of the Bush family). It is no secret that FDA is broken and desperately needs to be fixed. Choosing a person to lead CDER (for the second time) who has been at FDA for almost her entire career, signals  that Commissioner von Eschenbach is neither ready nor willing to implement the systemic changes that are so drastically needed at the agency.  Maybe something will change at FDA when someone other than George W. Bush is in the White House?

Until next time….

Good Luck and Good Job Hunting!!!!!

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Amgen announced today that US regulators added black box warnings to its erythropoietin drugs, Epogen and Aranesp. Similar warnings were also added to Johnson and Johnson’s Procrit which is licensed from Amgen. For those of you who don’t know, getting a black box warning on a drug label is like getting the “kiss of death” from a marketing and sales perspective. It certainly will not help sales of these products!

The new warnings approved by the Food and Drug Administration warn that the company's drugs increased death and accelerated tumor growth in patients with several types of cancer, including breast and cervical. Prior labeling warned of similar risks in other types of cancers.

The actions taken by the agency were not unexpected but suffice it to say there are a lot of unhappy Amgen and Johnson & Johnson employees in a Thousand Oaks, CA and New Brunswick, NJ

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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Where have the folks at FDA been hiding for the past decade?  I thought that by now everybody had heard about multi-drug resistant bacteria and the need for new antibiotics. Why, I bet that even President Bush knows this –hmmmm– well, okay– but you get my point!

FDA announced today that it needs more data and time to evaluate Johnson and Johnson’s “new indication” NDA for its antibiotic Doribax (doripenem). The antibiotic is already approved to treat urinary tract and intra-abdominal infections. The company is seeking approval to expand treatment to cover nosocomial or ‘hospital-acquired’ pneumonia as well as ventilator-associated pneumonia.

The new application was submitted in June 2007 but the FDA’s request for new data means that the review period has been extended by at least three months. Doribax is licensed from Japanese drug maker Shionogi and is currently undergoing regulatory review in Europe, Canada and in other countries.

This delay comes less than a month after the agency cancelled a meeting of its anti-infective drugs advisory committee which was scheduled for February 28. At that meeting, the agency was scheduled to review another J&J antibiotic ceftobiprole, which is being co-developed with Switzerland’s Basilea Pharmaceutica. No reason was given by the agency for cancellation of the ceftobiprole meeting which is being evaluated as a treatment of complicated skin and skin structure infections, including diabetic foot infections.

I am not sure why FDA can’t make up its mind about the approvability of new antibiotics. They certainly had little difficulty approving Vioxx, Zyprexa and Avandia.  Maybe FDA ought to hire some more microbiologists? 

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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For the past year or more, the US media has been vociferously bashing tainted imported Chinese goods any time it can. The tainted products have ranged from toys to dog food and most recently to Baxter’s heparin which has been associated with illnesses and deaths in this country.  

I suspect that this recent spate of China bashing has more to do with political and future economic issues than the safety and well being of the American public. Nevertheless, according to US Food and Drug Administration Current Good Manufacturing Practices (CGMP) regulations, companies that hold the licenses to manufacture pharmaceutical and biotechnology products assume full responsibility for the quality and safety of their products. To accomplish this, companies are required to test all raw materials, excipients and APIs (regardless of their source) before they are assembled to make a finish pharmaceutical or biotechnology product. The results of these tests must be carefully analyzed and compared with the product quality specifications established by the company and approved by FDA. If the test results for product ingredients are outside of the normal range of established specifications, then the company is obliged to reject the materials and not used them to manufacture product. To that end, there was clearly, something was wrong with quality testing at the Baxter heparin manufacturing facility because the adulterated heparin API should have been detected long, before it was used to manufacture the final product. Although the Chinese heparin may have adulterated, the onus was on Baxter (the company that holds the product license) and not the Chinese government to insure its final product met quality standards and was safe for public use.

Outsourcing is a fact of life in almost every sector of the American economy. Pharmaceutical and biotechnology companies import the materials they use in their products from all over the world. It is FDA’s job to insure that American companies remain CGMP compliant so that they produce safe and effective medications. To blame America’s regulatory shortcomings on foreign manufacturers and their governments is dangerous and naïve-not to mention chauvinistic.

Until next time…

Good Luck and Good Job Hunting (try Shanghai)!!!!!!!!!!

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I am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

Good Luck and Good Job Hunting!!!!!!!

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The US Food and Drug Administration said Monday it still had several "outstanding issues" with televancin an antibiotic being developed by Theravance Inc and Astellas Pharma of Tokyo. to treat skin infections.

The agency had canceled an advisory committee meeting scheduled for Wednesday that was set to evaluate the drug, televancin.

In a statement, the agency said that the meeting was being canceled to "allow time for the FDA to review and resolve several outstanding issues." The FDA said it would schedule an advisory committee meeting in the future, if needed.

Televancin is a once-daily injectable antibiotic that would be used to treat skin infections, including those caused by resistant bacteria like methicillin-resistant Staphylococcus aureus (MRSA). In October the FDA issued a so-called approvable letter for televancin, suggesting it needed a re-analysis of clinical data and the resolution of manufacturing issues at a third-party manufacturer that was not specifically related to televancin. The FDA said it continues to review televancin's application but didn't give a timetable for completion of the review.

Earlier this month the FDA canceled a Feb. 28 meeting for another antibiotic, ceftobiprole that would also be used to treat skin infections. That drug is being developed by a unit of Johnson and Johnson Co. and Switzerland-based Basilea Pharmaceutica Ltd. The FDA is expected to make a decision on whether to approve ceftobriprole sometime next month.

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Despite what the American public has been led to believe, the scientific, regulatory and safety issues related to biogenerics aka follow-on biologics, biosimilars, or subsequent entry biologics have been clearly investigated and are no longer controversial issues. All of the aforementioned "issues" have been analyzed and carefully vetted. This allowed EMEA, the European Medicines Agency in 2006 to craft a comprehensive regulatory approval pathway for biosimilars. For those of you who may not know, several biosimilar products are currently are the market and sold in all European Union member states. This begs the question–what is taking the US so long?

From the beginning, big pharma and big biotech have unequivocally and steadfastly opposed any legislation that would allow biogenerics to be approved and sold in the US. The trade groups BIO and PhRMA have literally spent millions of dollars lobbying members of Congress to oppose any legislation that would allow approval of biogenerics in the US. Now, in a sudden and unprecedented about face, big biotech and pharma have thrown their collective weight behind proposed biogenerics legislation that will be introduced in the near future by Representative Anna Eshoo (D-CA).

As far as I can tell, the primary reason for this sea change is the market exclusivity that may be afforded to innovator companies by the legislation. A quick perusal of the bill reveals that innovator companies will be granted 12-year market exclusivity for a product after its initial licensure. Further, under certain circumstances, this period of market exclusivity for an innovator product may be extended to 14.5 years. Also, reference product sponsors (innovator companies), as well as interested third parties (most notably universities) that own patents on the reference product may sue a biogeneric applicant for patent infringement. Under certain circumstances, such litigation could delay or prevent approval of the biogeneric product.

So what does the proposed legislation mean for biogeneric manufacturers seeking regulatory approval for their products in the US?  Unfortunately, it means that a biogeneric product application may not be approved or made effective until 12 to14 years after the original date of licensure of the innovator (reference) product. It also opens the door for patent litigation against biogeneric manufacturers to hinder or delay approval of their products. In my opinion, the proposed legislation is extremely one-sided and biased toward innovator companies. More importantly, it seems to me that the real intent of the legislation is to discourage (rather than encourage) biogeneric manufacturers from seeking US approval for their products, i.e. there are no real financial incentives or inducements for these manufacturers to seek approval because of the excessively-long market exclusivity period for innovator products.

On the surface, the proposed legislation would appear to be a long sought victory for biogeneric advocates and the American public which would benefit from less costly versions of potentially life-saving biotechnology drugs. That said, it seems to me that the proposed legislation is nothing more than a disingenuous attempt by big biotech and pharma to placate biogeneric advocates and the American public. In reality, the legislation provides innovators companies with a legally-binding regulatory approval pathway that will allow them to maintain or extend their monopolistic stranglehold on blockbuster biotechnology products. I think that the US Congress can do better when it comes to biogeneric legislation–the American public not only deserves it but demands it!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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By law, drug makers are prohibited from marketing or promoting (in any way) their medicines for uses that have not been approved by FDA. But, somewhat paradoxically, physicians who are licensed to practice in the US can prescribe drugs for uses beyond FDA-approved indications, a practice known as off-label use. The agency is no stranger to the issue of off-label drug use and has vigilantly policed the industry over the last decade to prevent the practice. Drug makers including Pfizer, Astra Zeneca, Eli Lilly, Amgen and others have been targeted by federal prosecutors for off-label marketing practices. Click here to see which types of drug are commonly prescribed for off-label use.

However, in something of a policy reversal, FDA officials proposed last Friday new guidelines that would allow pharmaceutical companies to use peer-reviewed medical journal articles to promote drugs for unapproved uses. The proposed guidelines will replace a law that expired in 2006 law. Under the expired law, companies had to submit copies of the articles to FDA for review before sending them to physicians. Under the new proposal, drug companies don’t have to submit articles to the FDA before distributing them to physicians. The agency says it will not punish companies for distributing literature on off-label use if they adhere to certain practices. Articles should not be false or misleading and should come from a peer-reviewed journal that is not influenced by a company. The proposal also says companies should attach a disclaimer to the materials indicating FDA has not reviewed them.

I, along with Congressional Democrats, most notably Henry Waxman (D-CA), am totally baffled by the proposed new guidelines.According to Mr. Waxman, the new guidelines would create a “large loophole” in laws against off-label promotion. “It’s a conflict of interest for the company to be promoting sales when they haven’t been able to establish that a drug is safe and effective through the rigorous FDA process,” he said. Not to mention that a company could save hundreds of millions of dollars by not conducting clinical trials to gain approval for an off-label indication. Risperdal, a Johnson and Johnson medication that is approved to treat serious mental disorders like schizophrenia, bipolar disorder and irritability associated with autism was used off label 66% of the time and brought in $4.2 billion in 2006. If you were the CEO of J & J would you spend any additional monies to win approval for new indications for Risperdal?

I would think that by now the agency would have figured out that drug manufacturer are incapable of policing themselves; there is simply too much money at stake. And, unfortunately, profits will always come before patient safety.  In my opinion, the proposed guidelines are another egregious example of just how much influence the pharmaceutical and biotechnology industries have at FDA. The Bush administration has done everything in its power to destabilize and emasculate the agency. The American public no longer has confidence in FDA and the products that it approves. Something has got to change to restore a sense of wellness in America!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Insmed a small, Richmond Va-based biotechnology and manufacturing company has upped the ante in the fight to bring follow-on biologics to America.  After spending some time on Capitol Hill, company executives  found that “people in Washington, as well as payors and patients don’t have an understanding at a reasonable level of the debate that is going on and the issues” surrounding that follow-on biologics debate. To reach as wide an audience as possible and frame the debate on the issues” the company decided to use the Internet to take the initiative to the next level–the Internet.

A key to Insmed’s initiative is an economic study on the potential savings follow-on biologics could provide to patients, payors and healthcare providers. The study is still being conducted and its results will be published on the net when available. The campaign also includes advocacy components that like user-generated content (blogs) and social networking sites. Recently, Insmed posted a video clip on YouTube that feature one of its scientists extolling the virtues and cost-saving advantages of follow-on biologics.

As many of you may know, I have long been an advocate of legislation to allow the approval and sale of follow-on biologics in the US.  Unfortunately, until now, only one side of the debate–from big biotech and BIO–has been heard by the American public. This has largely been due to marketing muscle and deep pockets of big biotech coupled with a lack of unity among follow-on biologics advocates. Web 2.0 with its social networks, blogs and video sites allows people with the smallest voices to be heard. And, sometimes those small voices can turn into  roars!

Kudos to Insmed for having the courage to boldly go where no generics manufacturer has gone before–on YouTube! Yeah baby!!!

Until next time….

Good Luck and Good Job Hunting (see you on Web 2.0)!!!!!!!!

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The Bush administration's proposed 2009 fiscal year budget for the FDA includes not only a 5.7 percent increase but a plan to seek authority to allow the agency to approve abbreviated applications for follow-on biologics.

As part of the budget package, the administration said it is seeking regulatory authority for the FDA to approve follow-on biologics, also called biosimilars or biogenerics, which would be financed through user fees.

The House and the Senate both introduced follow-on biologics legislation in 2007, with the Senate's bill moving the furthest by achieving passage by the Health, Education, Labor and Pensions Committee. Lawmakers have pledged to move the legislation forward in 2008.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), said "BIO strongly believes that the FDA should have a pathway for the approval of follow-on biologics, which protects patient safety and promotes continued innovation," Greenwood added that "The creation of a pathway for follow-on biologics is a top legislative priority for BIO, and we are meeting with members of the House and Senate to encourage them to consider and pass follow-on biologics legislation this session." This is quite a policy turnaround for BIO which over the past 8 years has spent tens of millions or more lobbying against allowing follow-on biologics in the US.

Even more shocking than the BIO turn around, was the first ever plea last week by the Whitehouse to pass legislation to craft legislation to create a regulatory approval pathway for follow-on biologics-what’s up with that? I guess Bush and his big biotech buddies finally realized that large sums of money can be made in the follow-on biologics/biogenerics business. This possibility was not lost on the Europeans, who created a regulatory pathway for approval of biosimilars (what follow-on biologics are called in Europe) several years ago! Biosimilars are already on the European market–who said that Europeans were less entrepreneurial than Americans?

Contrary to statements made by FDA officials last week, which suggested that FDA would craft the follow-on biologics legislation, it now appears that FDA will  work closely with Congress to draft a legislative proposal for approval of  follow-on biologics. I don’t think that Congress’s involvement is a good idea given the political wrangling, deal-making and concessions that must be made in order to get legislation passed. As the old adage goes, something is better than nothing.

It looks as though follow-on biologics may become a reality in the US. As I mentioned in previous posts, I don’t think Americans will see follow-on biologics on the market before 2010 or 2011. That said, it gives us Americans something to look forward to!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!

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US Food and Drug Administration regulators announced on Friday that it will take three months longer than expected to decide whether Entereg, a treatment for post-operative ileus being co-developed by GlaxoSmithKline, will receive marketing approval. The drug was originally supposed to be reviewed for an up-or-down decision on Feb. 10.

Entereg is being co-developed with Pennsylvania-based Adolor Corporation. Post-operative ileus affects patients after bowel surgery. Symptoms include constipation and other gastrointestinal dysfunction.

An FDA advisory panel recommended approval in January but said Adolor needed to come up with a better plan to manage long term use of the drug. FDA regulators are concerned about safety data showing that long term use of Entereg can have adverse cardiovascular effects.

Adolor has submitted a new risk-management plan to the FDA, which will take the extra three months to review it.  GlaxoSmithKline will split the revenue from any U.S. sales of Entereg with Adolor and is responsible for commercialization of the drug outside the country.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Things are not going well these days for Wyeth or the US Food and Drug Administration. In the latest of a series of complaints over FDA's safety review of drugs and industry influence on the agency, a Senate panel found flaws in its scientific objectivity when it reassigned an agency veterinarian over unfounded conflict –of- interest accusations by Wyeth.

The congressional inquiry looked into how the FDA dealt with Wyeth’s accusations against Dr. Victoria Hampshire, an FDA regulator who was helping to review the safety of one of Wyeth’s lucrative veterinary drugs. The case centers on Proheart 6, an injected dog heartworm medication that Wyeth pulled from the market in September 2004 after Hampshire linked the drug to dog deaths. Wyeth later complained about alleged bias by Hampshire. The company claimed that she intend to sell competing drugs through her own Web site. After Wyeth made the allegations, Hampshire was abruptly reassigned to another job within FDA and her case was referred to the U.S. attorney's office for possible criminal prosecution. Federal prosecutors quickly dropped the case, and much to FDA’s chagrin, in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.

Congressional investigators discovered that FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could easily have been checked but were not. As it turned out, Hampshire’s did little business at her website and did not sell any products that competed with Proheart 6. In fact, she actually sold Wyeth’s Proheart 6 until the company pulled it from the market. Go figure….

In a letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, panel Chairman Senator Charles Grassley (R-Iowa) wrote that the panel’s findings suggest “that the scientific process is being compromised internally" at the FDA. Also, he wrote that the case brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."

FYI, a FDA advisory panel narrowly voted to keep Proheart 6 off the market shortly after Hampshire was reassigned in 2004.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

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The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspectors. However, despite repeated attempts by lawmakers, the Bush administration has steadfastly refused to endorse or consider budget increases for the agency. Instead, White House officials have urged the agency to uses any means possible to “bolster the aggressiveness and effectiveness of foreign health regulators” to prevent unsafe or tainted products from reaching the US market. I do not want to sound overly cynical but good will can go only so far with financial inducements or incentives.

Despite the obvious need for more inspectors, von Eschenbach admitted that his plan to post inspectors in foreign countries is “only in its infancy”. Also, he hasn’t decided whether he will ask Congress for additional funding for the agency or find money in the current budget for the foreign inspectors. I suspect that “finding money” in the current budget would translate into curbing other regulatory activities at FDA –something that would not bode well for the already-embattled agency. The inability of von Eschenbach to secure funding to train and deploy new inspectors is another reason why I believe that the FDA Commissioner ought not to be a political appointee!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!

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Can anything else go wrong at Amgen? FDA regulators said on Thursday that they were reviewing the results from two recent studies that provided more evidence of serious risks for some cancer patients treated with anemia drugs, sold by Amgen Inc (Epogen & Aranesp) and Johnson & Johnson (Procrit). For those you who don’t know, J&J licensed Procrit from Amgen so there is really little difference between J&J’s Procrit and Amgen’s Epogen. Aranesp is a second generation, longer-acting version of Amgen’s Epogen.

In the studies, researchers used  Aranesp or Procrit to elevate a patient's level of hemoglobin to 12 grams per deciliter or higher, although many patients did not reach that level. Current warnings on the drugs say hemoglobin levels should not rise above 12 for patients with cancer. The FDA said the studies showed that patients with breast or advanced cervical cancer who were treated with the drugs died sooner, or had more rapid tumor growth, than similar patients who were not given the medications.

Based on these new data, it is almost certain that the agency will insist on label changes to include strong warnings regarding the use of EPO drugs to treat oncology patients. Maybe there is a black box warning in Amgen’s future?

Amgen's stock hit a new 52-week low on Thursday, dipping down to $45.25 and closing at $45.69. It has traded as high as $76.95 in the last year but has taken a beating with the decline of its anemia-drug franchise.

The similarities between Amgen and Pfizer are becoming more apparent each day. Both are largest companies in their respective sectors (biotech and pharma) and have relied almost exclusively on blockbuster franchises (and weak pipelines) to bolster their stock prices! As you may recall, both companies have laid off large numbers of employees over the past year to cut costs. Maybe bigger (biggest) is not always better?

Until next time….

Good Luck and Good Job Hunting!!!!

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According to the Eye on FDA blog, FDA has announced an upcoming meeting on stem cells.  This excerpt was recently published in the federal register...

"On April 10, 2008, the committee will meet to discuss scientific considerations for safety testing for cellular therapy products derived from human embryonic stem cells. , the committee will meet to discuss updates on the following topics: (1) Research management related to the September 29, 2005, review of research programs of the Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research; (2) 's Somatic Cell Therapy Letter; and (3) recently released FDA guidance documents."

I am not sure what they will talk about given the Bush administration’s intransigence on embryonic stem cell research. Don’t you just love it when Federal agencies waste your tax dollars to hold meetings when there is nothing to talk about? Go figure……

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!

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The US Food and Drug Administration (FDA), like other federal agencies during the Bush administration, has been hobbled by a lack of leadership and an agency-wide feeling of ennui. What do you expect from a federal agency that didn't did not have a Director for 5 out of 8 years since 2001? At present, the agency is in disarray, grossly ineffective and under siege.

Over the past 5 years or so, numerous product recalls and safety issues with newly-approved drugs have caused many medical professionals and the American public to lose faith in FDA. This is clearly evident by a willingness of the US Congress to step in and assume many of the regulatory activities and legal responsibilities granted to the agency in the Food, Drug and Cosmetic Act of 1938. For example, the New York Times reported today  that a Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug. The House Committee on Energy and Commerce demanded more information about delays in the trial, which was completed in April 2006 but whose results have not yet been released. Independent scientists have viewed the results of this study as crucial because it is the first trial that would answer whether Zetia’s ability to lower cholesterol has real biological benefits for patients. The results might also help answer nagging questions about Zetia’s safety.  I ask: "Why are their still nagging safety questions about a blockbuster drug that has been on the market since 2002? "

FDA’s mission is to insure that all approved drugs and medical devices are safe and effective for Americans. Overall, from a historical perspective, I think that the agency has accomplished its mission and done an outstanding job. It is only recently that things have begun to become undone and spin out of control. I believe that the time has come for FDA to “step up to the plate”  to right itself and get back on track. Personally, I would rather have medical and regulatory experts rather than politicians reviewing medical and scientific data to determine whether a drug is safe and efficacious. FDA may be broken but the damage is not irreversible. With a little determination, hard work and competent leadership the agency ought to be able to regain its former reputation as a preeminent regulatory agency.

Until next time….

Good Luck and Good Job Hunting (they are looking for a few good men and women)

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The FDA ruled today that GlaxoSmithKline’s blockbuster diabetes drug Avandia will now carry as part of its label a warning advising that its use might raise the risk of suffering a heart attack.

A black box warning is the sternest warning a drug can carry and still remain on the market in the U.S. Avandia already carries a black box warning advising it could cause or exacerbate congestive heart failure in some patients.

With 2006 sales of almost $3 billion, Avandia has been a major revenue driver for Glaxo.

Look for continued corporate right sizing at GSK through 2008.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!

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Genentech announced yesterday that it is delaying a plan that would have limited the use of its cancer drug Avastin to treat wet macular degeneration. Earlier this month, Genentech unveiled plans to ban purchases of Avastin by independent compounding pharmacies to prevent them from creating smaller doses of the drug that can be used by ophthalmologists to treat wet macular degeneration.  By banning sales of Avastin to these pharmacies, Genentech sought to force ophthalmologists to use Lucentis($2,000 per dose) in lieu of Avastin –which is (40 to 50 times lower than a comparable dose of Lucentis–to treat eye disease. Lucentis, which was recently approved to treat wet macular degeneration, and Avastin®, have very similar mechanisms of action.

 

The company acted to reinstate it supply of Avastin to compounding pharmacies after senior Genentech officials met with the American Academy of Ophthalmology and American Society of Retina Specialists. I guess doctors still have some clout over the disingenuous practices of some drug companies.

 

The FDA also weighed in on the dispute and reiterated in a statement that the agency did not previously ask Genentech to stop distributing Avastin to compounding pharmacies and that it has not taken any action to limit the off-label use of Avastin to treat wet macular degeneration.

Don’t you just love it when drug companies try to blame FDA for their failed avaricious plans to increase corporate profits and bolster their stock prices?

 

Until next time…

 

Good Luck and Good Job Hunting  

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In an attempt to dispel the notion that it is “dysfunctional” and "lax in policing drugs once they are on the market", the US Food and Drug Administration (FDA) earlier this week launched MedWatch - The FDA Safety Information and Adverse Event Reporting Program. An integral part of the new program is The Drug Safety Newsletter a quarterly publication that provides information on the findings of selected postmarketing drug safety reviews from FDA's Center for Drug Evaluation and Research.

The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities. FDA hopes the newsletter will raise awareness of reported adverse events, and stimulate additional adverse event reporting by healthcare professionals. The first issue of the newsletter contains reviews of the following products (information in the brackets are the most serious side effects)

• Rituximab (marketed as Rituxan): [Progressive Multifocal Leukoencephalopathy (PML)]
• Modafinil (marketed as Provigil): [Serious Skin Reactions]
• Temozolamide (marketed as Temodar): [Aplastic Anemia]
• Deferasirox (marketed as Exjade) -recently approved new molecular entity
  

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Publication of this newsletter fulfills a commitment FDA made in its January 2007 response to the Institute of Medicine's (IOM) 2006 Report on The Future of Drug Safety - Promoting and Protecting the Health of the Public.

The newsletter is available at The FDA website.  Also, it will be sent electronically to those who subscribe to the Drug Safety Newsletter or to the MedWatch E-list.

To subscribe to this publication directly, go to the Drug Safety Newsletter section of the FDA site, enter your name and e-mail address in the appropriate fields, and select the "Join the List" button.  Hopefully, this new publication will inform consumers about the potential adverse effects and side effects of marketed prescription medications.

Until next time.....

Good Luck and Good Job Hunting!!!!!!!!!!!

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Although industry and academia share a common bond (no pun intended), which is obviously science, the lexicons of these two seemingly similar but parallel worlds are markedly different. For example, do you know what the acronyms IND, NDA, cGMP, cGLP, BLA, CTD, PK or PD stand for? If you cannot decipher any of them, you ought to forget about getting a job in industry and stay in academia. If you know what 95 % or less of them mean, I highly recommend that you get some additional training before applying for your first industrial position. If you are one of the lucky few who recognized and correctly interpreted 100% of the acronyms, you are either working in industry or recently completed some postgraduate training in drug development and regulatory affairs. The point that I am trying to make is that you cannot possibly expect to get a job in industry if can’t speak the language that you need to know in order to succeed! As the old saying goes “You need to learn how to walk before you can run”.

So, take the test and your score will determine whether you are ready to apply for that long sought after job in the pharmaceutical or biotechnology industries.

Footnote: For those of you who are interested, you can decipher all of the acronyms that I listed by visiting and rooting around the FDA website.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!

Find information on Diversity recruiting at DiversityJobs.com.

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The New York Times reported today that an FDA advisory committee voted on Monday against imposing a new restriction on the use of EPO-like drugs to treat dialysis patients with kidney disease, offering a rare reprieve to Amgen, the manufacturer of the drugs.

The panel voted 14-to-5 against an F.D.A. proposal to set a fairly specific upper range on the drugs’ use. Several studies have linked overuse of the drugs to cardiovascular problems and deaths and, when used to treat cancer patients, to a worsening of tumors.

Nevertheless, although yesterday’s vote made it less likely that there would be drastic restrictions on the use of the drugs in kidney patients, the levels of use are unlikely to return to those common before the safety concerns took hold. Even while rejecting the proposed ceiling, most panel members recommended a treatment target lower than what some dialysis clinics and kidney specialists previously used.

Further, the F.D.A. said it was proposing to remove assertions on drug labels that assert that use of these drugs improved the quality of life for patients, saying the data to support such claims was inadequate. In March, the F.D.A. changed the labels for EPO to say that these drugs should be used as sparingly as necessary to avoid blood transfusions and that hemoglobin levels should not exceed 12 grams a deciliter.

Yesterday’s panel was far easier on Amgen than one in May that considered the safety of the drugs for use by cancer patients. After that meeting, Medicare sharply reduced its reimbursement for EPO drugs used in cancer treatment. This decision caused Amgen’s stock price to plummet to its lowest levels in almost a decade.

Despite this small victory, it is unlikely that the decision will affect the previously announced layoffs scheduled to take place in the very near future at Amgen.

Until next time…

Good Luck and Good Job Hunting!!!!!!!

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Can anything else go wrong at Pfizer? Unfortunately for Pfizer employees, the answer is yes. Pfizer and FDA announced late last week that they found detectable levels of the mutagen/carcinogen ethyl methanesulfonate (EMS) in Viracept, the company’s flagship anti-HIV medication. EMS has long been known to be a potent mutagen and carcinogen. I can attest to the mutagenic potential of EMS, because in my former life as a bench scientist I routinely used it to generate point mutations in the bacteria that I was working with.

Pfizer and FDA agreed not to recall the drug in the US because the quantity of EMS found was “low”. However, Roche, the company that sells Viracept in Europe, did recall the drug (slightly higher levels of EMS were found in the European version of Viracept). Predictably, FDA cautioned that although there are no human data, EMS has been shown to cause mutations, tumors and birth defects in animals and is a "potential human carcinogen. Not surprisingly, Pfizer advises children and pregnant women not to start the drug, although children already taking it may continue (really?).
How EMS got into both the US and European versions of the drug remains a mystery. If I had to guess, it is likely that there are significant quality control and quality assurance issues at the manufacturing plant(s) that produces Viracept. Alternatively, the EMS may have always been present in Viracept (as a contaminant or chemical by product) but nobody thought to look for it until recently. According to one report, “Pfizer is working with the FDA to prospectively limit EMS levels in Viracept, while still considering the immediate needs of patients on therapy. This is nonsense. There are other protease inhibitors that HIV-infected patients can try before they continue to take EMS-tainted Viracept. I think that Pfizer should voluntarily recall Viracept and eliminate all traces of EMS before it is reintroduced to the US and European markets!

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!!!!

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