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BioJobBlog readers who understand Current Good Manufacturing Practices (CGMP) for pharmaceuticals and biologics know that the US Food and Drug administration is mandated to review approved drug manufacturing facilities once every two years. While this is the mandated inspection schedule, most industry insiders know that manufacturing plant inspections now take place once every three or more years. This has resulted because of an increased reliance by US drug makers on foreign manufacturing facilities to produce licensed pharmaceuticals and biologics, a lack of regulatory oversight by the agency during the Bush administrations and funding shortfalls that have resulted in a shortage of FDA inspectors.

Congress recently took the agency to task about a lack of oversight for food and drugs manufactured in foreign countries. In September, the Government Accountability offices reported that FDA inspects foreign drug facilities on average once every nine years as compared with every 30 months or more with US plants. To correct this, FDA announced that it aims to increase reliance on third party inspectors in other countries to maintain better oversight of ex-US manufacturing plants. In other words, it is less costly to train and work with inspectors already in foreign countries rather than send US inspectors overseas.

In a post last week on the Pharmalot Blog, Ed Silverman reported that Bloomberg News reviews almost 10,000 inspections at US manufacturing plants from 2000 until September 30, 2010. While the Bloomberg report did not provide details on the frequency and nature of violations uncovered at the inspections, the results of the reports were eye-opening. According to Ed:

“The FDA makes 0.9 visits, on average, to each facility each year, compared with 0.6 visits annually when George W. Bush was in the White House. Looked at another way, the agency NOW visits each of the 2,567 plants registered in the US almost once a year.”

Further he noted:

“Some of the biggest drugmakers do not have a good track record when it comes time for FDA inspectors to visit their plants. Overall, the FDA found violations at 54 percent of plants inspected last year, up 20 percent from a decade low in 2007, according to data obtained from the agency by Bloomberg News. And 80 drugmakers failed more than half of their inspections.”

So, which companies had the poorest inspection track records? Ed noted

“Abbott Labs failed 59 percent of 111 inspections; Pfizer flunked 57 percent of 202 inspections; Merck bombed out on 52 percent of 134 visits and Johnson & Johnson failed 48 percent of 161 inspections. By contrast, [generic drug manufacturer] Mylan passed 79 percent of 56 inspections!”

Republicans are threatening to slash FDA funding for US inspections mainly because the agency is focusing more on overseas manufacturers and suppliers. In response to the funding cut threats, the Obama Administration proposed that drug manufacturers whose production plants fail inspections would be required to pay fines of roughly $49,000. At present, there are no mandatory fines levied against drug makers that fail FDA inspection (the agency can and does impose fines if companies that fail inspections refuse or are reluctant to fix the problems that were uncovered).

I find it interesting that despite the numerous drug recalls and problems with drug safety of approved drugs over the past few years that the Republicans, could in good conscience, threaten to cut FDA funding to increase the frequency of inspections to bring them in line with the mandated once every two years rather than once every 2.5 to 3.0 years that has been the norm for the last decade.

Until next time....

Good Luck and Good Job Hunting!!!!!

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I want to state at the onset of this post that I am an ardent supporter of online patient communities because I believe that the exchange of information between people who suffer from the same or similar medical conditions is vital to their health and well being. Further, I believe that social media will force physicians, the medical community and the US healthcare system to become more transparent, open and interactive. That being said, in this past Sunday’s New York Times, Natasha Singer wrote an extremely revealing article about some possible, unforeseen “side effects” associated with membership in online patient communities.

The reason why these online communities exist is for patients to commiserate with one another and exchange personal stories and medical information. While personal stories may be emotionally satisfying for patients, it is their medical information and demographic data that is extremely valuable to drug makers. To that end, many online patient communities inform their members that they reserve the right to share information and data for research purposes. And many of them do!

To be clear, I am not suggesting that the people who create or manage online patient communities have avaricious, nefarious or otherwise unsavory ulterior motives for the medical and patient demographic data that they collect. However, these communities need to generate revenue in order to stay in business and drug makers are willing to pay for access to it.

According to Singer, the popular PatientsLikeMe community admits that it sells health and medical data gathered from member profiles (but with certain identifying information removed) to pharmaceutical companies and others for scientific and marketing research purposes. Further, a large number of unbranded “disease awareness” pages have recently begun to appear on Facebook and YouTube. In her article, Singer contends that “drug companies may pay people to moderate patient forums [in the community] or give testimonials but might not prominently display that fact to participants. Other sites collect consumer health data to help drug makers’ aim at specific kinds of consumers, using psychological cues.” At a medical communications meeting that I attended several years ago, a MySpace sales rep freely admitted to me that it allow pharmaceutical companies to mine profile data in order to develop targeted marketing campaigns. Is Facebook next?

Finally, while the Health Insurance Portability and Accountability Act of 1996 (HIPAA) restricts the way health care providers use and disseminate patients’ information, consumer health websites and online patient communities aren’t subject to its privacy provisions. In other words, there are no regulations guiding the privacy and use of medical information and data collected using social media tools! Essentially, this means that the persons who run online patient communities can do pretty much whatever they like with the medical and personal information that they collect!

As I stated at the beginning of the post, I am a social media enthusiast who subscribes to the notion that if used correctly, social media can help to better inform and improve the lives of people suffering from various disease. That said, I also believe that people who choose to participate in online communities MUST be fully informed about the potential uses of the personal information and data that they contribute. Until the Food and Drug Administration provides some regulatory guidance on the use social media to collect and disseminate medical information patients will be at the mercy of the entities that run online patient communities. Let’s hope that they see fit to “do the right thing.”

Until next time...

Good Luck and Be Careful What You Say Out There!!!!!!!!!

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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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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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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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According to a recent analysis conducted by Covalence a Geneva Switzerland-based organization that tracks the ethical reputation of multinationals, the pharmaceutical industry’s ethical reputation dropped from first to third on Covalence’s all-time EthicalQuote ranking that monitors 10 industries. Further, over the past year, pharma has only managed to achieve an overall ranking of 8th on the list.

The reasons given for the ongoing decline are increased attention on product risk and decreasing media coverage of donations and philanthropy of pharmaceutical companies. The recent high profile coverage of the safety risks associated GlaxoSmithKline’s Paxil and Merck’s Vioxx are good examples of why the ethical image of pharma continues on its downward spiral.

To improve their image, ethicists recommend that drug companies showcase innovative drugs in poor countries, reduce prices to increase access to drugs and loosen intellectual property rights so that there is global access to potentially life-saving drugs. While several companies like Merck and Roche have gone down this path, it may be too little too late.

Until next time…

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

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Last year was a banner year for the pharmaceutical lobby (the largest in Washington DC). It spent over $168 million to inform Congress about issues that its members thought were in the best interest of the pharmaceutical and biotechnology industries. So what were the main issues that occupied a majority of the lobby’s time?

• blocking the importation of inexpensive drugs from other countries
• protecting pharmaceutical patents both within the United States and abroad
• ensuring greater market access for pharmaceutical companies in international free trade agreements

You are probably wondering which company was the top spender—it was Amgen! As you may recall, Amgen’s EPO franchise was under intense medical, regulatory and congressional scrutiny because of safety issue that resulted from over prescription. In my limited understanding of how things work in Washington, I have been told by lobbyist friends of mine that there is no better way to solve nagging problems than by paying influence peddlers to make them go away.  That said, Amgen’s lobbying costs paled in comparison with the $23 million spent by Pharmaceutical Research and Manufacturers of America a pharmaceutical industry trade group.  You Go PhRMA!!!!

A quick perusal of the top lobbying list reveals that all major US pharmaceutical companies invested heavily to influence members of Congress to allow them to preserve their stranglehold on the American healthcare system. Not surprisingly, all of the major foreign pharmaceutical manufacturers were also on list.  Much to my surprise, Teva, the Israeli generic manufacturing giant made the list this year—so it goes!

I guess altruism is out and avarice is still in! Hat tip to Pharmalot.

Until next time….

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Over the past few days, many drug companies have been reporting their earnings for the first quarter of 2008.  Few, if any, (except for Biogen/IDEC),  met the numbers that Wall Street analysts had expected and most reported that profits were "way down." Unfortunately, this means that more layoffs at drug manufacturers can likely  be expected in the coming months and that drug prices may rise.

Of course, the poor performances of these companies had little bearing on the compensation packages that many of the CEOs of these companies received in 2007.  It never ceases to amaze me that companies can lay off thousands of workers to cut cost s and then turn around and give CEOs who performed horribly (which led to the layoffs) tens of millions or more in compensation.  Just think how many workers could have kept their jobs and been able to feed their familiies if mediocre CEOs, who didn't do their jobs were paid what they are worth!

Ain't capitalism great?

Until next time....

Good Luck and Good Job Hunting!!!!!

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