What’s Next for the FDA’s Draft Social Media Guidances?

December 08, 2014

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on:

  1. The timing and procedures for pharmaceutical and biologics companies to submit interactive promotional media to the Agency (See Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics);
  2. The conditions under which pharmaceutical and medical device companies can voluntarily correct independent third-party misinformation on the internet and social media platforms (See Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices); and
  3. The requirements relating to presentation of risk/benefit information for pharmaceutical and medical device products on internet or social media platforms with character space limitations (See Internet/Social Media Platforms with Character Space Limitations – Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices).

As we near year end, the comment period for each of these draft guidances has come to a close. The dozens of comments submitted to the FDA address a broad range of policy, legal and technical issues – some making discreet, nuanced suggestions or requests for clarification, and others posing broader critiques of FDA regulation in the social media age. We have identified a handful of these broader issues that the FDA will need to grapple with and ultimately address as it moves toward finalizing the guidance documents.

Read What’s Next for the FDA’s Draft Social Media Guidances?