Will the FDA Part 15 Meeting on Social Media Actually Bring on a Global Freezing?

The FDA is finally holding a meeting to gather input about the agency's role in providing some guidance respecting the use of social media by the medical products industry.  It is long overdue, as mentioned many times here.  

The FDA is a big boat and it doesn't turn on a dime.  That means that the process for hunting and gathering for information, and reacting to that information, takes a great deal of time.  And the effort at actually establishing new policy is laden with delay and is processed more thoroughly than junk food.  

And so we see the effort to put some definition to the rapidly changing landscape of social media that a hearing has been scheduled for November.  Hopefully everyone is thinking about their approach to this extremely important meeting.   The agency is also opening a docket that will remain open for several weeks where stakeholders can file commentary.  

Then, presumably, the agency will go back and digest all the input from the hearing and from the docket.  After that, one would hope that they would generate some sort of draft guidance, and then open that up for comment.  That comment would be digested and some of it incorporated into a final guidance document that would provide parameters.  By that time, several months, if not even years, will have likely come and gone.  In the meantime, there will be a total vacuum of information, which as we all know, nature hates and the realm of social media involvement will be reliant upon parameters being set not by policy, but by warning and untitled letters.  

What will happen in the meantime?  Will the fact that so much time will pass before FDA gets its job done mean that pharmaceutical and other medical products companies will hold back their involvement in social media even though their most valuable asset - their brand - is being shaped there more than in any other medium?  And that while patients turn increasingly to the Internet and to social networks for healthcare information upon which they act, the actual companies that have done years of research on medicines will be absent from the discussion?  

That really can't happen.  There is no better example of why than the development of Sidewiki.  If I can now go to a pharma home page and write about an off-label use, that company needs some guidance about how to respond.  Some companies are not allowing employees to look at any Sidewiki that is attached to a home page of the company.  By my count, there are now five major pharmaceutical and biotech companies that have Sidewikis attached to their home pages and also some major product home pages.  Again, a company's brand is one of its most valuable assets.  How is it protected by not reading and correcting misinformation that may be present in the Sidewiki?  Yet by intervening at all, then a company could be assuming liability.  It is a little like watching a person drown.  You are under no legal obligation to save them.  But once you do move to save them, if you don't do it right, you do incur potential legal liability.  So the safest thing may be to do nothing.  But does that make it the right thing?

That is why a Global Freeze does not do any good.  And the bottom line is this.  One important message for FDA during the public meeting in November has to be resounding from industry and that is "we cannot afford to wait, from either a business point of view, or from a public health point of view, for FDA to complete this process in order to get guidance."  In short, there needs to be an interim mechanism for providing feedback to industry.  Without it, not only does business suffer, but public health is put at risk and the FDA image does not get its shine back.  Everyone loses in a Global Freezing.   

Comments

[Chris Iafolla]

Agreed Mark, a global freeze out of pharma's efforts in social media would be detrimental to the industry. The optimist in me would like to think that developments such as Sidewiki will force the hand of pharma to develop a social media strategy. After all, Sidewiki is one of the first social media tools that leaves companies no choice, the conversation is in their backyard. However, the realist in me understands that this is not the typical course of action for Big Pharma. Look no further than the industry's response to a few wrist slaps around search advertising. Ads plummeted for fear of further sanctions. Hopefully the FDA will keep the lines of communications open as this guidance is established and help to avoid the freeze out.

[Betsy Raymond Stevenson]

Not every company will react the same way, however, I know at least one pharma communicator who has been told not to say anything publicly on the subject of social media, as the FDA might interpret it as a comment by the corporation.