Thursday, November 5, 2009

FDA to regulate social media? Ask Sermo physicians.

Here's a letter I got from the founder or Sermo:

On November 12th & 13th the FDA will hold public hearings to assess the role of social media relative to the FDA's charter. Sermo has been asked to provide the FDA with insight on this question. This is an important opportunity for this community to help define what its role should be relative to the FDA and what role the FDA should play in this medium. Key issues that the FDA wants to address are:

  1. For what online communications are manufacturers, packers, or distributors accountable?
  2. How can manufacturers, packers, or distributors fulfill regulatory requirements (e.g., fair balance, disclosure of indication and risk information, postmarketing submission requirements) in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications (e.g. microblogs, mobile technology)?
  3. Questions specific to Internet adverse event reporting.

How many people at the FDA really understand social media? I still meet people on a regular basis who don't know about Twitter. What's Twitter? They hear the name on the radio or television, but they have no concept of microblogging.

Mark your calendars for November 12 and 13 and stay tuned...

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