S. 483 — Responsibility in Drug Advertising Act of 2025

This section adds to the list of prohibited acts under FDCA section 301 (21 U.S.C. 331) a new subsection (jjj) prohibiting direct-to-consumer advertising of a prescription drug approved under section 505(c) in violation of new section 506M. New section 506M (1) bans such advertising, including on social media platforms, for the first three years following approval, subject to a waiver by the Secretary of Health and Human Services (HHS) during the third year if the drug sponsor applies and the Secretary determines affirmative public health value; (2) authorizes the Secretary to prohibit such advertising thereafter upon determining significant adverse health effects from post-approval data; (3) directs HHS to revise drug advertising regulations within one year of enactment; and (4) applies to drugs approved on or after one year before enactment.