FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

Lexology January 18, 2024
Sheppard Mullin Richter & Hampton LLP

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established in the final rule, “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” (CCN Final Rule).

The CCN Final Rule, published in November 2023, establishes five key standards for the “major statement” which provides information related to the major side effects and contraindications of an prescription drug communicated directly to consumers....

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