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FDA Guidance on Responding to Unsolicited Requests for Off-Label Information
The Social Media Guidelines Nobody Expected!

All I Got Was This Lousy GuidanceTwo days after Christmas, on December 27, 2011, while most of us were still on vacation, the FDA quietly issued "Guidance for Industry Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices." Section VI. of this guidance addresses responding to unsolicited requests on public forums such as the Internet.

While this may not be the "social media" guidance many people were expecting, it does include guidelines for responding to unsolicited requests for off-label information encountered through "emerging electronic media."

This article takes a closer look at how the off-label guidelines apply to social media such as Youtube, Blogs, and Twitter.

Topics include:
  • A Bit of History
  • Defining "Off-label"
  • What We Expected Was This
  • In Best Interest of Public Health
  • Public vs. Private, Solicited vs. Unsolicited
  • Youtube and Solicited Requests
  • Blogger Example of "Solicited Request"
  • Proving Solicitation is Difficult
  • Twitter Example of "Solicited Request"
  • Private Responses and Serving the Public Interest
  • Sales and Marketing May be Seen, but Should NOT Be Heard From!
  • The Burden of Responding
  • Docket Open for Comments
  • Legal Challenges
  • Chart: FDA Guidance Translator
Download full article (PDF)

PMN111-02
Issue: Vol. 11, No. 1
Publication date: 26 January 2012
Word Count: 3,784

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Vol 11, #1 Contents






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