The Food and Drug Administration (“FDA”) has adopted a Final Rule requiring that when a direct-to-consumer TV or radio ad for a prescription drug makes statements relating to side effects of the drug, those statements must be presented in a “clear, conspicuous, and neutral manner.”  This Final Rule implements one requirement of the Federal Food, Drug, and Cosmetic Act.

Advertisers must begin complying with this rule commencing November 20, 2024.

The FDA will use the following standards to determine whether the statement is presented in compliance with the new rule:

  • Present all information in consumer-friendly language and terminology that is readily understandable;
  • Present audio information regarding the side effects in a manner that is at least as understandable as the audio information presented in the rest of the ad with respect to volume, articulation, and pacing;
  • If in a TV format, present the information using audio and text concurrently, and  present written text on a contrasting background for a sufficient duration and in a size and font that would allow the information to be read easily; and
  • Not include distracting elements, whether in text, images, and/or sounds, which would detract from the statement of side effects.

If you have any questions about these new prescription drug ad requirements or how they should be applied, please contact your friendly FHH attorney.