
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.
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.
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