Health Law Highlights

FDA’s Final Rule on Direct-to-Consumer Advertising – Presentation of Risk Information

From Foley & Lardner, LLP, by Kyle Gaget and Jordan Smiley:

  • The FDA has released a final rule regarding direct-to-consumer (DTC) advertising for prescription drugs and biologics.
  • The rule requires that DTC ads include the most important risks associated with the drug or biologic being advertised.
  • The FDA has also clarified that companies can include a “major statement” in their ads to fulfill this requirement.
  • The final rule also addresses the use of alternative media for DTC ads, such as social media and online platforms.
  • Companies are encouraged to review and update their DTC advertising practices to ensure compliance with the new rule.