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FDA Issues Long-Awaited Draft Guidances on Internet and Social Media Advertising

Nancy M. Parsons

Nancy M. Parsons,

Washington, D.C.

17 June 2014
This morning, the Food and Drug Administration (FDA) finally issued long awaited guidelines regarding internet and social media advertising for prescription drug and medical device manufacturers.  The proposed guidelines came in the form of two draft guidances for industry:

The first guidance offers recommendations on how prescription drug and device companies can correct inaccurate information about their products posted by third parties on internet and social media sites.  The second guidance addresses how these same companies can discuss their products on internet platforms with space restrictions, including social media sites and paid search links on Google and Yahoo.  Comments for both guidances are due within 90 days.

Today’s draft guidances address two issues of particular interest to Hogan Lovells clients – providing links to risk information within microblogs and correcting misinformation about products from third parties.  Thus, we urge everyone to read these carefully.

Today’s draft guidances add to the social media draft guidance that the agency promulgated in January: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics, see our HL Regulatory blog post here.  FDA has also indicated that its guidance agenda for 2014 includes guidance regarding the use of links in advertising and promotional labeling.

Nancy M. Parsons

Nancy M. Parsons,

Washington, D.C.

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