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Solving the Social Media Adverse Event Reporting Problem
Is It Just Too Much "Noise" to Sift Through?

Wheat v ChaffPharmaceutical marketers claim to be prevented from engaging in online conversations with consumers because of FDA's AE reporting requirements. No drug company wants to be responsible for pro-actively monitoring the entire Internet for potential adverse events. Even so, are adverse events reported on social media sites just a lot of useless "noise" and not worth the effort to sift through?

Many presenters at FDA's November 2009 public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools addressed this problem and offered solutions.

Comments submitted to the FDA after the meeting offer more details, which are reviewed in this article.

Topics include:

  • AE Monitoring Policies
  • Technology Can Help
  • Identifying the Reporter
  • Solicited vs. Spontaneous AERs
  • Terms of Use
  • Tools for Monitoring AEs
  • What Sites Should be Monitored?
  • Are J&J Agents Trolling for Adverse Events on the Internet?
  • Patient Privacy Issues Cited
  • Reporter "Noise"
  • How Frequently Are AEs Mentioned in Social Media?
  • Not All AERs Are Equal
  • Lilly's Pilot Study Yields Nada

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PMN93-04
Issue: Vol. 9, No. 3: March 2010
Word Count: 4098

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