• FDA Proposes to Amend Regulations Regarding the Presentation of Major Statement Information in Direct-to-Consumer Broadcast Advertisements
  • April 15, 2010 | Authors: Edward M. Basile; Daniel Francis Donovan; Marian Lee; Christina M. Markus
  • Law Firm: King & Spalding LLP - Washington Office
  • On March 29, 2010, the Food and Drug Administration (FDA or “the Agency”) published a proposed rule to amend the regulations concerning the presentation of major statement information in direct-to-consumer advertisements (DTC ads) for prescription drugs (21 C.F.R. § 202.1). The Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FDCA) to require that the major statement in DTC television and radio ads relating to the side effects and contraindications of a prescription drug be presented in a “clear, conspicuous, and neutral manner,” effective March 25, 2008. As mandated by FDAAA, the proposed rule implements this new requirement and sets forth the standards for determining whether the major statement in an ad complies with this FDAAA requirement. FDA proposes that the standards in the final rule would become effective 90 days after its publication in the Federal Register.