Broadcast Ad ‘Major Statement’ Q&A Guide

FDA has published a guidance, Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers, to help small entities understand and comply with the standards established in that final rule. The document says the final rule establishes standards to help ensure the major statement relating to side effects and contraindications in such ads is presented in the required manner.

“The major statement provides information relating to the major side effects and contraindications of an advertised prescription drug,” FDA says. “Note that this is a selected presentation of the major side effects and contraindications of the drug and not a listing of every risk. Direct-to-consumer TV/radio ads are required to include a major statement.”