FDA Issues Proposed Guidance on Social Media and Internet Communications for Pharmaceutical and Medical Device Manufacturers

27 June 2014
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Key takeaways:

  • Last week, the FDA issued two long-awaited draft Guidance for Industry documents addressing prescription drug and medical device manufacturers’ product communications on the Internet and on social media platforms.
  • One Guidance would require that manufacturers using limited character space communications, such as Twitter, include material risk and other information in their communications. The second Guidance would establish a safe harbor permitting manufacturers to correct misstatements posted on the Internet by independent third parties without triggering full application of labeling and advertising regulations.
  • These Guidance documents raise several important questions for members of Industry and should be carefully scrutinized before finalization.