16 Years in the Making: FDA Publishes Final Rule Related to Presentation of Risk Information in Direct-to-Consumer Prescription Drug Ads in TV and Radio Format

Lexology December 1, 2023
Ropes & Gray LLP

On November 21, 2023, the U.S. Food and Drug Administration (“FDA”) published a long-awaited final rule on the “Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.”¹ This final rule, which amends FDA’s prescription drug advertising regulations, implements a statutory requirement established by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) that direct-to-consumer (“DTC”) advertisements for prescription drugs in TV and radio format present the so-called “major statement” related to side effects and contraindications “in a clear, conspicuous, and neutral manner.”

FDA originally published a proposed rule to implement this requirement more than 13 years ago in March 2010. Despite the significant passage of time and the way...

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