I am sure that any of you that have listened to radio or watched TV have heard a prescription drug ad and  have struggled with keeping up with the fast talking and not so slow walking people, scene, or scrolling of text on direct-to-consumer ads.  FDA has been working to develop standards over the course of time and their work has made the ads easier for consumers to understand and comprehend.  While it might not be an easy thing to do, the final rule in its prepublication form (here ) which will appear in the Federal Register (FR) on November 21, 2023 takes a good stab at defining the principles to make the ads more consumer friendly. 

The prepublication version of the FR notice is 87 pages and provides both the regulatory history behind FDA’s efforts to put guardrails on DTC advertising but also reviews the comments FDA received in response to the proposed rule and the Agency’s responses to those comments.  The actual regulation changes appear at the end of the document and consist of a mere two (2) pages. 

The final rule (which is very interesting from a historical perspective) provides the FDA’s thinking on this important and somewhat controversial subject (that is, the ying and yang among the drug companies, the public and the health care providers) and codifies five (5) standards in human drug advertisements in television or radio format that demand the “major statements {are} presented in a clear, conspicuous, and neutral manner.” The Agency states that they will consider that the ad meets these standards if: 

  1. It is presented in consumer-friendly language and terminology that is readily understandable.
  2. Its audio information, in terms of the volume, articulation, and pacing used, is at least as understandable as the audio information presented in the rest of the advertisement.
  3. In advertisements in television format, it is presented concurrently using both audio and text (dual modality). To achieve dual modality: (1) Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio; and (2) The text is displayed for a sufficient duration to allow it to be read easily.  For purposes of the standard …, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio.
  4. In advertisements in television format, for the text portion of the major statement, the size and style of font, the contrast with the background, and the placement on the screen allow the information to be read easily.
  5. During the presentation of the major statement, the advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the major statement.

It might be easy to outline the parameters, but we will see how easy (or not so easy) it will be for FDA to  implement and enforce this final rule!