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Social Media Adverse Event Reporting Safe Harbors
It's Time for FDA to Open Up the Internet to Rx Advertising Like It Did with TV!

Unsafe harborAdverse event (AE) monitoring and reporting are the two primary hurdles that pharmaceutical marketers must overcome before they can feel comfortable using the full two-way conversational features of the new Internet (ie, Web 2.0, aka "social media").

This article presents ideas for regulatory "safe harbors" under which pharma companies would be relieved of the responsibility of monitoring social media for adverse events. Whether or not the FDA implements these or some other form of safe harbor is anybody's guess. But if the drug industry really wants a safe harbor -- and there is some question about that -- this could be a start.

As background, the article also includes a detailed summary of responses to the survey "FDA Regulation of Drug & Device Promotion via the Internet & Social Media" regarding social media adverse event monitoring, processing, challenges, and uncertainties.

Topic headings include:
  • What Is an Adverse Event?
  • FDA Clarifies Pharma's AE Reporting Responsibilities
  • "AEs" Within SM Discussions
  • The Adequate Provision Safe Harbor Precedent
  • AEs, Internet, & the FDA
  • Monitoring Adverse Events
  • Processing AEs from Social Media Sources
  • Challenges Handling Adverse Events Found on SM Sites
  • Uncertainties Regarding Adverse Events Found on SM Sites
  • Tit-for-Tat Tithe on Pharma Marketing
  • The Adverse Event Reporting Widget Safe Harbor
  • There's Value in Adversity

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PMN89-01
Issue: Vol. 8, No. 9: October 2009
Word Count: 6193

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Vol 8, #9 Contents







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