S. 652 — Protecting Patients from Deceptive Drug Ads Act

This section establishes civil penalties under new subsection 303(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) for social media influencers (i.e., private individuals with perceived credibility promoting products on social media) and health care providers who knowingly or recklessly make false or misleading promotional communications regarding FDA-approved or licensed prescription drugs (including compounded drugs under sections 503A or 503B), with penalties in amounts specified under subsection 303(g)(1) and assessed via procedures similar to subsection 303(g)(2); excludes bona fide patient care, medical research statements, or personal opinions. (1) It directs the Secretary of Health and Human Services to issue guidance within 180 days of enactment on administering subsection 303(h), including factors for determining false or misleading communications (e.g., omissions on safety, efficacy, or labeling) and platform-specific considerations; (2) amends section 502(n) (21 U.S.C. 352(n)) to extend prescription drug advertising requirements (e.g., brief summaries of side effects) to telehealth providers or platforms facilitating patient-prescriber connections (excluding private practitioner-patient communications), with regulations required within one year of enactment; (3) provides that such amendments take effect 180 days after finalization of those regulations; and (4) requires drug manufacturers or health care providers to report payments related to promotion of covered drugs under the Open Payments program (section 1128G of the Social Security Act). (Thus, the provision targets influencer-driven misinformation while expanding advertising and transparency rules for digital prescription drug promotion.)