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The US Food and Drug Administration finally released portions of the long-awaited guidance documents that will help to implement the development and approval of biosimilar molecules under the Biologics Price Competition and Innovation Act of 2009 (BPCIA)

Yesterday the agency issued three guidance documents which represent only a small portion of the total guidance package that will be necessary to develop and commercialize biosimilar products in the US

They are:

1. Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
2. Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
3. Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

For a more detailed analysis of the guidance documents please check out a post by James N. Czaban. According to Czaban (and many other in the biosimilar space) these first three guidance documents represent “baby steps” towards implementing the specifics of BPCIA. To that point, Czaban suggests that:

“These Guidances, while helpful in expressing some of the FDA's general approaches, but will be of limited specific value with respect to any particular product”

Stay tuned for more updates.

Until next time...

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

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A study conducted in November 2011 by Cegedim Strategic Data, a market research and promotional audit firm analyzed the world’s top 100 pharmaceutical companies expenditure on traditional promotional (marketing spends) and then compared that spending with their presence on Facebook and Twitter.

Not surprisingly, Pfizer, Novartis and Merck (the world’s largest big pharma companies) finished in the top three for traditional promotional spending. However, their use of social media i.e. Twitter and Facebook varied widely. For example, Pfizer—the top promotional spender—was first in its number of Twitter followers and third in the number of likes on Facebook. On the other hand, second ranked Novartis was fifth in the number of Twitter followers and in seventeenth position for likes on Facebook. Finally, third ranked Merck was fifteenth in the number of Twitter followers (third for the number of tweets) and in the tenth position for the number of likes on Facebook (but has more pages than any of its Facebook competitors).

Other notable companies included:

• Johnson &Johnson, eleventh in promotional spending and number two on the number of Facebook likes
• Roche, number fifteen on the promotional spending list was ranked number two for the number of Twitter followers
• Proctor and Gamble which ranked a distant 54^th in promotional spending was number four on the Twitter follower list

What does this all mean? A whole lot of nothing because nobody can determine what effects the use of social media has on the bottom line for most pharmaceutical companies. Unlike other industries, where social media can be used to sell products, it cannot be used for direct promotional purposes in the life sciences industry. While most people will tell you this is because of the lack of guidance by FDA on the use of social media, the bottom line is that social media will never be allowed for direct-to-consumer advertising in the pharmaceutical industry. That said, pharma and biotech will have to find other uses for social media including clinical trial recruitment and retention, adverse event reporting, employee recruitment and retention and education and outreach.

Until next time...

Good Luck and Good Tweeting (and Liking)

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Mark Senak, author of the EyeonFDA blog and a life sciences/healthcare social media enthusiast, wrote a fantastic piece yesterday that provides cogent ideas and insights into the need for FDA to expeditiously craft guidance on the use of social media in the pharmaceutical and healthcare industries.

Here are the facts. First, according to the Pew Internet and American Life Project, social media has fundamentally changed the way in which we interact with one another and ushered in a new era of communication. Unlike the old, so-called “broadcast communication method”—information is continuously streamed from a static source, websites, television, radio etc, to perspective customers and stakeholders—the new paradigm requires that communications must be personal, portable and participatory for effective messaging. Second, the primary source of information sought by most persons who use the Internet is healthcare and medical information. While much of the content is accurate, some is not; which may put persons seeking medical information at great risk. In other words, social media is not just about marketing and medical education; it is also about preserving public health.

The agency has historically been unable to issue guidance on new forms of communication. For example, FDA held its first public meeting in 1996 on Internet use by life sciences and healthcare companies. Sadly, the agency has yet to issue any official guidance on this topic. In late 2009, FDA held another public meeting and promised that draft guidance on the internet and social media would be forthcoming by the end of 2010. Unfortunately the guidance did not materialize in 2010 and it has been delayed twice in 2011. Recently, the agency publicly reaffirmed its commitment to issuing the guidance but without a specific timetable for its release. Consequently, it is anyone’s guess when or if the guidance will be released.

Unlike many, I do not believe that FDA guidance on the Internet and social media is absolutely necessary. However, I will admit that issuance of said guidance will provide drug and healthcare companies with some of the assurances that they need in order to actively use social media to engage patients, physicians and other stakeholders. For this reason alone, FDA ought to issue the guidance (which is never perfect and always a work in progress) and end the social media stalemate that currently exists. Failure to do so may have serious consequences on the public health of many Americans.

Hat tip to Mark!

Until next time...

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

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Late last week, Janet Woodcock, head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation (CDER) made public comments which suggested that the long awaited guidance for approval of biosimilar products in the US was complete and likely to be issued by the end of this year. According to the Pharmalot Blog, another agency official suggested that the guidance may be “as early as the next few weeks, maybe even days.” Conventional wisdom suggests that the end of the year scenario may be more likely!

As widely anticipated, the guidance will resemble that already in place in Europe and will rely heavily upon analytical similarity of the biosimilar to the innovator product to determine the clinical testing requirement for approval of the molecule. Interestingly, Woodcock went out on a limb and suggested that the FDA approval process may make interchangeability feasible for biosimilars. For those who may not know, interchangeability or substitution allows pharmacists to substitute generic small molecules drugs for brand names when filling a prescription. This practice is legally allowed by the Hatch Waxman Act because FDA approval of a generic indicates that it biologically equivalent or identical to the branded molecule.

For those of you who have not close paid attention to the biosimilar brouhaha, a regulatory approval pathway for these molecules was implemented in Europe in 2004. Since that time, at least 10 biosimilar products have reached European markets. At present, biosimilars are still not legal in the US. While Woodcock and other FDA officials may be proud of their progress, why has it taken over 12 years for the agency to divine regulatory guidance for this class of molecules? 

Until next time...

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

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Over two years ago at the beginning of the social media/pharma debate, I proposed that social media platforms like Twitter and Facebook would be great for adverse event reporting for drugs, biologics and medical devices. At the time, the suggestion was largely ignored and relegated to the category of “unlikely to happen anytime in my lifetime.” 

Imagine my delight after reading a post on today’s Pharmalot Blog which suggested that the Medicines and Healthcare products Regulatory Agency (MHRA)—the UK equivalent of the US Food and Drug Administration (FDA)—is considering whether to allow the public to use Twitter and Facebook to report side effects and adverse events.

According to the Pharmalot post:

"The MHRA is now “actively working on introducing other ways of reporting to make it easier and encourage more reporting,” Mick Foy, the MHRA group manager for vigilance and risk management of medicines, tells GP. “Applications for smartphones, improved web reporting forms and the use of social media such as Twitter and Facebook are being carefully considered as potential routes for reporting.”

While the MHRA is considering the use of social media, it is not clear that the agency will ultimately adopt Twitter, Facebook or other mobile applications for adverse event reporting. Like in the US, possible adverse reported in the UK must meet several criteria before they are verified and considered to be reportable adverse events. Despite potential problems and pitfalls, the fact that the MHRA is even considering social media as a means to improve adverse event reporting is laudable; considering the fact that FDA has yet to provide guidance on the use of social media in the US life sciences industry. Many companies, social media advocates and mobile app developers have been waiting for the said guidance for almost two years now.

Like it or not, social media is now part of the social fabric of today’s world. Rather than fighting its implementation, life sciences companies would use their considerable creative talent to figure out how to integrate and leverage social media (in non-promotional ways) to their benefit.

Until next time...

Good Luck and Good Tweeting and Following!!!!

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For the past few years, I along with many others have advocated the use of social media platforms (mainly Facebook, Twitter and YouTube) by life sciences companies. Despite a very positive beginning by companies like Novo Nordisk, Johnson and Johnson and others, the implementation of social media in the life sciences industry has been stymied by a lack of regulatory guidance by the US Food and Drug Administration (FDA) and legal and commercialization concerns. While many believe that FDA guidance on the topic will be the panacea that they were waiting for, I personally don’t believe that it will make one bit of difference. That said, Steve Woodruff, the author of the IMPACTIVITI Blog, provides one of the best analyses that I have encountered that explains why social media and pharma don’t work well.

In a post entitled “Time to Give Up on Pharma and Social Media,” Steve cogently provides four compelling reasons why it will be difficult for pharma to ever embrace social media for commercial purposes. They include 1) the lack of regulatory guidance; 2) pharma does not communicate or interact in real time; 3) personnel turnover, short term thinking, lack of innovation and too much focus on quarterly profits; and 4) pharma’s addiction to centralized, one-way controlled communications. His bottom line:

“Public, interactive, real-time social media platforms and commercial pharma communications simply don’t mesh well” 

While I agree with Steve that social media may not be ideal for commercial purposes in the prescription life sciences industry, it may be perfectly well suited for pharmacovigilance and adverse event reporting, clinical trial recruitment and management, education, community outreach and employee recruitment and retention. These are not new ideas. But, because they cost money to implement and don’t contribute the most company’s revenue-driven bottom lines, life sciences companies have not actively explored or embraced them for these purposes. 

Whether big pharma and biotech companies like it or not, social media is here to stay. And, if these companies fail to act soon, they eventually will begin to lose their competitive edges and perhaps more importantly, market share. 

Until next time.. 

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

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Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time...

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

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The Pharmalot Blog today reported that FDA, for the second time in four months, has postponed plans to issue its widely anticipated guidance on social media. Guidance was initially expected last December. When FDA announced it wasn’t going to be able to make its original deadline, the guidance was rescheduled for release in the first quarter of 2011, which was presumably was to occur this month. At this point it is anyone’s guess as to when the long awaited guidance document(s) will be issued by the agency.

According to the Pharmalot post the guidance will address:

“responding to unsolicited requests; fulfilling regulatory requirements when using tools associated with space limitations; fulfilling post-marketing submission requirements; online communications for which manufacturers, packers, or distributors are accountable; use of links on the Internet and correcting misinformation…”

The agency further added:

“We are developing multiple draft guidances to address these topics to benefit industry and the public by ensuring that these draft guidances are meaningful and well thought out when they are issued.”

While many companies still contend that FDA’s guidance will be necessary for them to engage in social media, most have realized that if they wait for the agency’s guidance the social media craze may pass them by; possibly jeopardizing substantial financial opportunities afforded by social media in other industries. The notion that FDA’s guidance on social media will help pharma unravel the so-called social media conundrum is misguided and, in my humble opinion, wishful thinking. 

Companies who are familiar with working with FDA understand that guidance documents may offer some help to better understand certain regulations. But, it is generally up to a company with questions to directly solicit input from the agency rather than rely on an interpretation of a specific guidance recommendation (s). The goal of social media is to promote conversations and provide greater transparency surrounding both business and social interactions. Ironically, it appears the many of the companies that are most anxiously awaiting FDA’s social media guidance are the very ones that want to continue to develop products without involving the agency unless absolutely necessary. Go figure.....

Until next time...

Good Luck and Good Tweeting*

*Although FDA has yet to issue social media for the life sciences industry it has a YouTube Channel, Facebook Page  and at least two twitter accounts (@FDA_Drug_Info and @FDArecalls)!

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The US Food and Drug Administration (FDA) is one of those federal agencies that everyone loves to hate. Sometimes I think the FDA is more vilified than the Internal Revenue Service! Nevertheless, FDA’s mission is to provide the American public with safe and efficacious foods, medicines and cosmetics. And, despite some highly publicized missteps like Vioxx and Avandia in recent years, the agency has done a great job since it was created in 1930.

Mark Senak, who writes the always interesting and incisive EyeonFDA blog, published a piece outlining what consumer may expect from FDA this year. The highlights on his list include:

• Draft guidance regarding the Internet and the use of social media
• Increased enforcement of social media in the life sciences industry
• Renewed interest on divining a legal, regulatory approval pathway for biosimilars

While none of these items is new, one can only hope that the agency can finally deliver on implementing these policies.

Until next time...

Good Luck and Good Job Hunting!!!!!

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Mark Senak, author of the EyeonFDA blog and a feisty social media advocate and enthusiast today reported that the long awaited FDA guidelines for the use of social media by life sciences companies might not be completed until 2012. 

Mark, who is attending the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP), based his timeline on remarks made by during presentations by a couple of FDA employees from the Division of Drug Marketing, Advertising and Communications (DDMAC). According to Mark:

“A process begun in 2009 may see a milestone in 2010 with issuance of draft guidance, followed by commentary and revision and the issuance of a final of what will be much guidance, apparently.  A three year "event.”

Further, Mark offered this assessment:

“The Internet and social media landscape moves at the speed of light.  Consider that Twitter only came into existence three years ago.  The development of each new platform introduces new questions into the equation.  Consider the frequency and with what depth and breadth consumers consult the Internet and social media for health care information, and we have a priority that demands something faster than a three year event.”

While I agree with Mark that FDA should act faster to develop guidelines for the use of social media for promotional and non-promotional purposes, the existing guidelines for print and broadcast media are sufficient for companies (which abide by DDMAC regulations) to launch successful social media campaigns. A great example of this is Novo Nordisk’s novel Twitter campaign entitled “Race with Insulin” in which professional race car driver Charlie Kimball tweets about his use of Novo’s insulin products.  Novo contends that the campaign helps to dispel the notion that persons with type I diabetes are limited in what they can do personally and professionally (it also helps to sell more insulin!)

Some industry insiders and bloggers think that Novo’s Twitter campaign may be inappropriate and ill-advised. Like it or not, the Race with Insulin Twitter campaign is compliant with existing DDMAC regulations and no different than many other direct-to-consumer advertising campaigns that use paid company spokespersons. Personally, I think that criticism of the campaign is nothing more than “sour grapes,” i.e. Novo figured it out before other pharma marketers did!

The lack of FDA guidance on the use of social media will certainly hinder and perhaps deter other pharma companies from leveraging the true power of social media. However, the old adage “where there is a will, there is way” is particularly apt for those companies that are seriously considering social media in the absence of any notable regulatory guidance on the subject.

Until next time....

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

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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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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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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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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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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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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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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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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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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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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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