Yesterday and Today at FDA’s Part 15 Meeting on Social Media

It is 7:38 AM.  People are beginning to filter into the "bunker" as I have begun to call the meeting room at the National Transportation Safety Board, a room so buried that you cannot get a cell signal.  It is perhaps truly ironic, or perhaps intentional, that the FDA would schedule a hearing on social media in a room where there is no Internet access whatsoever.  Very funny Tom Abrams. 

Yesterday we heard from a lot of speakers, as we will today.  Lilly, one of only four pharmaceutical companies with the moxy to present, delivered a very comprehensive and thoughtful set of remarks, and included the issue that this process for addressing the ever-changing Internet is far too slow, and asked the FDA to consider more creative approaches such as holding regular workshops so that regulation could be managed more efficiently.  That was great, though I remain skeptical that the FDA will understand that urgency and act on it – as evidenced by the fact that we are on the verge of Web 3.0 and the agency is only now trying to figure out how to regulate Web 2.0.  

We also heard PhRMA introduce an idea that has captured the imagination of many to provide a "seal of approval" from the FDA through a logo that is placed on approved content.  Many, however, remain skeptical of this idea, particularly on the consumer side.  I have a FlipCam interview with PhRMA that I will be posting this evening when I can get access to DSL. 

There was a near universal sentiment yesterday that industry cannot be held responsible for content that it does not generate or encourage.  This was an attempt to emphasize that companies need to be able to correct bad Wikipedia entries, and get away from Sidewiki.  I didn't hear it myself, but through Eric Obenzinger at Google, that one speaker did utter the words "Mr. Google, Tear This Sidewiki Down…"  Ha ha. 

There was a LOT of data that came down the pike, and most of it out of Manhattan Research, so that by time the poor guy from Manhattan Research came up to speak, his data had been nearly used up.  But he was a great presenter.  The data predictably centered on a few key things – more people are using the Internet for healthcare to manage more medical issues than before.  Doctors are increasingly turning to electronic and digital resources over paper resources to get information on up to date treatments and procedures.  And social media is of increasing importance.  You would think that the FDA would have already known all this, but if they had, we wouldn't be sitting here now, would we?

The day ended up with Google presenting a new paid search paradigm.  No word on Sidewiki.  šŸ™‚

Today there will be a number of PR agencies and a few consumer groups, which is many more than there were yesterday.  Sermo will be presenting presumably about how doctors are using social media.  And WOMMA will be presenting their data on adverse events. 

In fact, most of the day will be spent examining the issue of the dreaded adverse event – which in my mind, has always been, continues to be, and will be a true red herring.

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1 Response to Yesterday and Today at FDA’s Part 15 Meeting on Social Media

  1. Rob Halper says:

    The quote about Mr. Google was by John Mack, of course!

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