FDA Adopts New Rules Requirements for “Side Effects” Statements in Prescription Drugs Ads on Broadcast Stations

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

Advertisers must begin complying with this rule commencingNovember 20, 2024.

The FDA will use the following standards to determine whether the statement is presented incompliance 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 shouldbe applied, please contact your friendly FHH attorney.