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May 13, 2011

FDA and social media ... again ... still .... Thoughts and today's presentation at MassMEDIC

Pushmipullyu Meet the love child of the FDA and the pharma and medical device industries: The Pushmi Pullyu.  ACOs and unicorns, step aside; the is the Pushmi Pullyu's day to shine.  (It is now a commonplace that an Accountable Care Organization -- a creature of the Affordable Care Act -- is like a unicorn: everyone can describe it, but no one has ever seen one.)

It's been 18 months since the FDA listening session on the use of social media in marketing drugs and devices, and after many months of thinking that some sort of guidance was just around the corner, the FDA decided to release for public comment a description of some research studies it would like to conduct before actually reaching a decision point about guidance for the use of social media in marketing drugs and medical devices.  As others have noted, this will take a while.  The studies, as described, are also not likely to yield useful, actionable data, in large part because they are hyper-focused on the web of today and the way people use it, and the online activities of the future (including the near future, say two years from now -- optimistically -- when the studies are complete and guidance is issued) will be different.  The agency has to be willing to articulate general principles, but it seems paralyzed on that front.

On another front, the Pew Research Center has just released a very useful report: The Social Life of Health Information, 2011, by Susannah Fox (with whom I have the honor to occasionally share space with on the blog of the Society for Participatory Medicine).  This study captures a snapshot of the the way we use the internet to solve health problems -- and many, if not most, of us are doing that one way or another.  Research conducted by Susannah and the Pew Internet & American Life Project can help folks tailor messages and tactics to be used in the deployment of health care social media -- both in the realm of health care and in the realm of pharma and devices.  Perhaps some day (soon!), the FDA will call on resources such as the Pew Research Center to turn around some illuminating studies within a short timeframe.  Until then, we're stuck with the pushmi pullyu approach to social media in the FDA-regulated space --regulators and the regulated community looking away from each other and not.  (Another aspect of this approach: the FDA uses social media on its own account, yet is uncomfortable with establishing parameters for tis use by the refualted community.)

Even in this ambiguous environment, folks can use social media for some purposes in the world of pharma and medical devices -- carefully, within some safe zones, following some clear locally-developed policies and procedures.  I'm speaking on the subject this morning at MassMEDIC.  Please let me know what you think:

David Harlow
The Harlow Group LLC
Health Care Law and Consulting



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