H.R. 1117 — Responsibility in Drug Advertising Act of 2025

This section establishes the short title of the Act as the “Responsibility in Drug Advertising Act of 2025.”

This section prohibits direct-to-consumer advertising, including on social media platforms, of a drug approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act during the first 3 years after approval, and adds a new prohibited act under 21 U.S.C. § 331(jjj) for advertising a drug in violation of new section 506M. It also authorizes the Secretary of Health and Human Services to waive that prohibition during the third year if the drug sponsor applies and the Secretary determines the advertising would have an affirmative value to public health, and to prohibit such advertising after the 3-year period if the drug has significant adverse health effects based on post-approval studies, risk-benefit analyses, adverse event reports, the scientific literature, or other appropriate resources. The section directs the Secretary to revise drug-advertising regulations within 1 year after enactment and applies only to drugs approved on or after the date that is 1 year before enactment.