FDA “Side Effects” Statement Requirements in Prescription Drug Broadcast Advertising Coming in November

Stations may have missed the Food and Drug Administration ‘s recent adoption of a Final Rule that will impact certain aspects of broadcast prescription drug advertising.

In a recent www.CommLawBlog.com post, Sara Hinkle, an attorney with TAB Associate member law firm Fletcher Heald Hildreth, said the FDA will require prescription drug advertisers to make statements relating to side effects of the drug in such advertising in what the FDA characterized as a “clear, conspicuous, and neutral manner.”  

Hinkle said the FDA will use “standards to determine whether the statement is presented in compliance with the new rule” and outlined the following standards. 

• 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.

Advertisers must begin complying with this rule on Nov. 20. 

Questions? Contact TAB’s Michael Schneider or call (512) 322-9944.