FDA Seeks Comments on Risk Information in Prescription Drug Broadcast Ads

The FDA is soliciting comments from industry members and shareholders on how direct-to-consumer drug advertising should depict risk information.

Broadcast drug advertisements are required to contain a breakdown of the drug’s side effects and contraindications, known as the major statement. The agency is soliciting comments to address concerns that the major statement does not fulfill its intended purpose. One of the most common criticisms is that major statements are too long, which can lead to customers misunderstanding or missing risk information, while others have suggested DTC broadcast ads do not feature enough risk information.

CDER’s Office of Prescription Drug Promotion is currently conducting research to determine the effectiveness of a “limited risks plus” disclosure strategy. This would involve limiting the risks in the major statement to the most severe, serious or actionable as well as an indication that other, lesser risks exist.