What We Didn’t Hear at the FDA Part 15 Meeting on Social Media

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Well, we heard a lot  week before last at the FDA's Part 15 Meeting on Social Media and Medical Product Promotion.

For example, we heard consensus that medical product manufacturers probably shouldn't be held responsible for what unrelated third parties write – i.e., wikis.  We heard that there may be an alternative to the paid search ads that got the Notice of Violation letters from FDA in April.  We heard that the encyclopedic disclosure of print ads (not an evidence-based intervention, by the way, but nevertheless imposed by FDA as if it is) are not practical on the Internet.  We heard that people are going more and more to the Internet for health information and making decisions based on that information, something we already knew, but which was perhaps still news to the FDA.  We even heard some references from the FDA panel to "the Internet World" which was reminiscent of one famous U.S. Senator who referred to the Internet as a bunch of tubes. 

We heard from far too few pharma companies, and far too many bloggers.   

But what we did not hear was actually more important in some ways than what we did hear.  What we didn't hear was:

  • Between now and the time of any supposed eventual guidance, what are we supposed to do?  The FDA is pretending that the real world, and yes, even the Internet World, attends to matters at their pace.  It doesn't.  Sidewiki launched in late September, Google Wave will presumably launch late this year and even Google's operating system which will probably have all sorts of new bells and whistles (one hopes) will launch sometime soon.  In other words, new Web 2.0 applications are launching that will raise new and important questions in the intervening weeks, while the FDA still wanders around in the Web 1.0 desert.  What are companies to do between now and whenever the FDA gets around to doing something (anything) about the Internet?  Even the time between now and the time the docket closes is frankly, too long to wait.  But we didn't hear anything about what companies, not to mention consumers, should do now.  Brands and public health move at a snail's pace.  Is that wise?
  • In this era of FDA's new transparency initiative, the FDA was completely mum about the process going forward.  "We're here to listen, not to talk" said Tom Abrams.  Well, ok, but frankly that isn't good enough.  What is the process going forward?  Who will be making the decisions about "Internet World"?  What is the timeframe?  Is it really a good idea to let all this ride and fail to use this as an opportunity to display the FDA's new transparency initiative?
  • Europe.  We didn't hear a darn thing about Europe.  And yes, it was a U.S. agency and a U.S. focus, so that seems appropriate.  I'm not suggesting otherwise.  But all of the statistics and talk was about the U.S.  But one has to wonder, what are other regulatory authorities doing?  By comparison, the FDA is positively Internet savvy and geeky compared to the EMEA.  Granted, we have DTC and more relaxed rules than other countries, but really – is the EMEA just going to proceed pretending that the Internet doesn't exist or that, despite regulatory confines, people in Europe aren't getting health care information from the Internet World because the EMEA doesn't want them to?  It is absurd.  

So as the dust from the meeting settles, and everyone is still analyzing what was said, it seems just as important, if not more, to focus on what was not said and what still needs to be said, even after over 70 presentations and two days worth of meetings in a buried room in Washington with no Internet access.  Or, perhaps we'll just have to wait for the next Dan Brown novel to get answers.   

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