New Adventures of Old FDA?

Everyone has logged in their summaries of the two-day meeting held by FDA in Washington last week about social media and the pharmaceutical industry.  Fabio Gratton (Ignite Health and a/k/a @skypen) has put together a Web site that fulfills a tremendous public service – that in one spot collects all information about the meeting – from presentations to news stories to tweets.  It is the kind of thing that the FDA maybe should have done for the meeting, and maybe needs to in the future for all of its public meetings.  But Fabio did it for this one.

The presentations are done, the docket is open for more comment. But at the end of the day, the big question is – what, if anything, will change?  With the Part 15 meeting on social media, did we see a new FDA begin to emerge, or did we just see a new adventure for the same old FDA?  I don't think there is a definitive answer to that question and some of the tea leaves suggest both.

Clearly, holding this meeting was an important milestone and almost certainly reflects a sincere desire on the part of the agency to learn about the Internet.  But so far, the hand the FDA has played with respect to social media has been to focus on each tree of rule and not the forest of possibility. 

What is meant by that turn of phrase is that when there is a technical violation of an existing rule, such as represented by the 14 NOV letters sent out on April 2, then the FDA acts.  That is the focus on the tree.  But if the forest – the greater public health isn't served by the action, the role of the technical violation seems exaggerated.  The FDA seems to be so focused on individual (and on rules inappropriate for the Internet) that the greater goal of public health support takes a secondary role to rule enforcement. 

A few themes floated to the top of the two days that beg the question – new FDA or old FDA?  They became clear through repeated remarks and can serve perhaps as a litmus test for FDA commitment to public health and the Internet:

• Industry should not be held responsible for material generated by others – In a clear reference to wikis of all kinds – Wikipedia and Sidewiki – there seemed to be near universal agreement that no one should be held accountable for content they have not caused to be generated.  Right now people are turning to resources such as Sidewiki in increasing numbers for health care information to help them guide their treatment decisions, yet there is a lot of outdated information in Wikipedia that needs correcting, putting public health at risk.  Companies are fearful of correcting such information, so the flawed stuff continues to influence decisions.
• Encyclopedic disclosure of risk in the context of paid search is not practical – The FDA has been trying to cram a square peg into a round hole by requiring encyclopedic disclosure of risk in the context of paid search.  This is in spite of the fact that there is no evidence anywhere that encyclopedic disclosure of risk serves any public health benefit whatsoever since, among other things, no one really reads it, much less heeds it.  Google has offered up, and some have begun to advertise, using a new paid search ad that discloses risk s well as carries benefit information.  Will this work?  It will probably take the FDA about as long to produce a social media guidance as it will to issue a NOV letter on this topic – so we really won't know. 

Tom Abrams closed the meeting by saying the words -  "Next Steps".  He then did not say one word about next steps.  The FDA has gone to great lengths to assure a new transparency – a blog, a launched initiative.  That's new FDA.  Not letting us know next steps around the social media guidance – that's old FDA. 

The FDA could let us know early on where we stand on some of these issues so we don't have to wait until a guidance emerges.  The public health threats caused by the status quo are clear.  Do we really have to wait months and months for answers.  Giving them now would be new FDA.  Waiting for an eventual guidance that is going to be outdated before it is even published, that would be old FDA.

This is not a good sign, but let's allow
time to play out and see what happens next. And so for now, the jury is out.  Will the meeting make a difference?  Does FDA have a better understanding of the Internet and how people use it to make health care decisions or was this just a new adventure of old FDA?