FDA Finally Issues Some Biosimilar Guidance Documents

Posted in BioEducation

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!!!!!!


An Analysis: Big Pharma and Social Media Usage

Posted in Social Media

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 54th 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)


EyeonFDA Blog: Why FDA Needs to Be Clear About Social Media

Posted in Social Media

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!!!!!!!!


Biosimilar Regulatory Guidance is Imminent

Posted in BioBusiness

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!!!!!!


UK Regulatory Agency Considering Using Social Media for Adverse Events Reporting

Posted in Social Media

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!!!!


A Death Knell For Social Media and Pharma?

Posted in Social Media

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!!!!!!!!



Social Media Update: US Food and Drug Administration To Regulate Mobile Apps?

Posted in Social Media

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!!!!!!!


FDA Delays Social Media Guidance Yet Again!

Posted in Social Media

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)!


What to Look for From FDA in 2011

Posted in BioBusiness

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!!!!!


FDA Guidance on the Use of Social Media May Not Be Complete Until 2012!

Posted in Social Media

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!!!!!!!!!!!!!