BREAKING – Latest Statement from FDA on the Draft Guidance on the Internet and Social Media

In response to inquiry about the status of the FDA’s Draft Guidance on the Internet and Social Media, originally set for release by the end of 2010 and reset to aim for the first quarter of 2011, the agency responded as follows:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has been researching draft guidance topics on the following issues related to Internet/social media promotion of FDA-regulated medical products:

  • Responding to unsolicited requests
  • Fulfilling regulatory requirements when using tools associated with space limitations
  • Fulfilling post-marketing submission requirements
  • On-line communications for which manufacturers, packers, or distributors are accountable
  • Use of links on the Internet
  • Correcting misinformation

Our goal is to issue one draft guidance that addresses at least one of these topics during the first quarter of 2011, but we cannot comment any further at this point as to exactly when any draft guidance will issue or any specific order in which the topics will be addressed. The public will be notified officially when any guidance is issued via Federal Register announcements.

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11 Responses to BREAKING – Latest Statement from FDA on the Draft Guidance on the Internet and Social Media

  1. Jeff Tippett says:

    Great post. Thanks for the information.

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  4. ok says:

    They do know there are only 8 days left in the first quarter right?

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  6. Bruce Grant says:

    The key word here is “goal,” which is not generally recognized as a synonym for “commitment.”
    My personal goal, for example, is the end of world hunger by 4:30 this afternoon. We’ll see.

  7. Casey Ferrell says:

    This is, verbatim, the same statement from December, is it not?

  8. Senak says:

    Casey – you are right! I did not double check and should have. The way it was given to me kind of indicated it was an update. Thanks for pointing out.

    Mark

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  10. Casey Ferrell says:

    Well, in that case it makes the likelihood of meeting the Q1 deadline even less probable. Wouldn’t someone at the FDA have connected the dots here? With one business week left and the angry mob at the gate, why reissue canned copy from three months ago? We’re left to speculate that they’re no closer to publishing a guidance now than they were when the last deadline passed…

  11. Senak says:

    Casey – Indeed. DDMAC’s dithering is one thing, but it is not a good example of effective communications, that is for sure. You might want to check out my post today – http://www.eyeonfda.com/eye_on_fda/2011/03/ddmac-unclear-transparency-on-fda-social-media-guidance.html