FDA Must Change Method for Regulating Social Media

I am at Day 2 of the Food and Drug Law Institute Advertising and Promotion Conference being held in Washington, D.C. (#FDLIAP)

Yesterday, there were a couple of presentations made by the Division of Drug Marketing, Advertising, and Communications (DDMAC) that reviewed enforcement trends among the various divisions and overviewed some future changes coming to the structure of DDMAC.  However, one of the areas of greatest interest was progress toward the development of some sort of Guidance on social media and the Internet by the agency.

Unfortunately, the news in that regard wasn't exactly new.  The FDA is hoping to issue the first of what will be more than one guidance by the end of this year,  related to the subject matter categories raised during the November 2009 Part 15 meeting held to solicit input into the development of guidance around social media and the Internet and the medical products industry. FDA could not say for sure that it would happen by the end of the year, but that was the goal.  They also stated that while they were planning more than one guidance document, they couldn't say how many.  I don't think they were being non-transparent, I got the impression they actually hadn't decided.  That isn't very comforting.

To the extent that there has been any light shed on the subject of social media and the Internet, it hasn't been on the macro level, but rather on the micro level, first though the infamous 14 Notice of Violation letters issued in 2009, and most recently through the issuance of an NOV letter for use of a Facebook "share" function.  Neither of these were very illuminating.  Instead of having definition of the entire environment, we are getting snippets expressed through regulatory action letters.   

The Internet is not new.  It has been around for a while.  So have search engines.  The two have profoundly changed the way that people get information and communicate forever.  Add to the mix social media, and the result has been a communications revolution the magnitude of which has not been seen since the advent of broadcast television.  

The Internet, long ignored by FDA, became more of a priority in 2009 when the FDA finally announced the Part 15 meeting and probable intent to produce a guidance.  Here is where we are in terms of progress:

FDA Progress Guidance
As you can see, a process begun in 2009, may see a milestone in 2010 with issuance of a draft guidance, followed by commentary and revision and the issuance of a final of what will be many guidances, apparently.  A three year "event".  

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.  What FDA needs is a more nimble process that continually assesses the evolving situation and responds accordingly making decisions based on evidence, and not old rules applied to new media (as was the case with the 14 letters) which added to confusion rather than providing clarity.

That process might look something like this.  The development of a new FDA Advisory Committee to advise the agency on health care communications and the Internet that would include experts from Google, Yahoo! and the Pew Research Center as well as experts in social media and healthcare and public health.  That would allow the FDA much more flexibility, timely response to new developments, the examination of new and emerging evidence and studies and would provide a much more informed communications environment that would hopefully result in fewer action letters that, when issued, are premised on more evidence-based reasoning.

That is part of my presentation today here at FDLI.  

 

 

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