USA – FDA issues new standards for DTC prescription drug ads

The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and radio advertising.

The rule, published on 21 November, implements a Food and Drug Administration Amendments Act requirement in effect since March 2008 and establishes five standards for conveying a DTC ad major statement in “a clear, conspicuous, and neutral manner” (RELATED: Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agendaRegulatory Focus 27 July 2023).

These standards require that:

  • The major statement is presented in language and terminology that is consumer friendly and readily understandable
  • Audio information in the major statement is as understandable as audio information in the rest of the ad in terms of volume, articulation and pacing …