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FDA Outlines Plans, Timing for Social Media Guidances

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Yesterday eyeonfda broke the news that FDA had made an announcement regarding draft guidance for the Internet and social media for pharma promotional activities (Backstory here)

Or, as Steve Woodruff pointed out, perhaps we should call it a non-announcement.

Essentially, FDA announced which topics they would be focusing on, and that they hoped to issue draft guidance that addresses at least one of these topics during the first quarter of 2011. According to @eyeonfda, the topics include:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools with space limitations (think Twitter, search, texts)
  • Fulfilling post-marketing submission requirements
  • For which online communications manufacturers, packers, or distributors are accountable
  • Use of links
  • Correcting misinformation

This morning I also ran across this article on the topic - FDA Outlines Plans for Social Media Guidances

The article states:

In an e-mail exchange Dec. 21, Ayse Yeaton with the Center for Drug Evaluation and Research (CDER) stated that the center’s promotional watchdog — the Division of Drug Marketing, Advertising and Communications (DDMAC) — has been researching six cyberspace issues for potential guidances and plans to release one of these sometime in the first three months of 2011.

So now we know the topics, and we know it’s going to be a little longer than we’d expected, since FDA had been quoted several times that they would issue guidance by the end of 2010.

So I have a couple of questions:

  1. Are we more clear - or more confused - than before FDA released this information? ... and,
  2. Did they really use the word "cyberspace" in their email???


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