FDA Releases New Rule and Guidance for Prescription Drug Advertising on Radio and TV

The U.S. Food and Drug Administration (FDA) has released a new rule and related guidance on direct-to-consumer (DTC) prescription drug advertising on radio and television.

The FDA’s current rule requires television and radio commercials that promote the name of a drug and conditions of use to include a “major statement” – information relating to side effects and situations where use of the drug may be harmful. The FDA’s new rule sets out five general standards to help ensure that major statements in DTC advertisements are truthful and not misleading.

    • Consumer Friendly Language. Advertisements must clearly state the name of the drug, and the major statement of side effects must be presented in language that is readily understandable by consumers. It should not include technical or medical jargon familiar only to health care professionals.
    • Understandable Audio Information. Audio information must be understandable in terms of volume, articulation, and pacing, and should be at least as understandable as the rest of the commercial. “Rapid fire” disclosures in advertisements will no longer be permitted.
    • Major Statement Must Be Presented Concurrently in Text and Audio. Television advertisements must present the major statement concurrently in the audio and visual portions of the ad.
    • Textual Information Must Be Easily Readable. The on-screen text in television advertisements must be presented against a contrasting background for sufficient duration and in a font size and style that is easily readable.
    • No Distractions. Advertisements cannot have statements, text, images or sounds that detract from comprehension of the major statement. In particular, no other sounds, including music, should be in the audio during the side effect disclosure portion of the ad.

The new rule applies to pharmaceutical companies, including manufacturers and distributors of prescription drugs. Radio and television broadcasters, while not directly regulated by the FDA, should be aware of the new requirements when airing advertisements for prescription drugs. The new rule is effective May 20, 2024, and pharmaceutical advertisers must be in compliance by November 20, 2024.

If you have questions about the new FDA rule and guidelines, contact an attorney in our Media practice group.

Categories: Media