H.R. 3789 — DTC Act of 2025

This section states congressional findings on direct-to-consumer advertising of prescription pharmaceuticals, including its permission in only the United States and New Zealand; $6.046 billion in 2018 ad spending (up 4.8% from 2017); Medicare's $560 billion drug spending from 2016-2018, with 58% on advertised drugs; and studies showing increased prescriptions and spending. The section expresses the sense of Congress that greater price transparency—such as disclosure of wholesale acquisition cost (WAC)—is needed to promote competition, enable informed consumer decisions, and reduce demand for higher-cost drugs.

This section requires that, not later than July 1, 2026, direct-to-consumer advertisements for prescription drugs and biological products eligible for payment under Medicare (title XVIII) or Medicaid (title XIX) and subject to FDA regulations on disclosing side effects, contraindications, and effectiveness also include a clear and conspicuous disclosure of the wholesale acquisition cost (WAC) for a 30-day supply (or typical course of treatment, if applicable). The requirement exempts such drugs and biologicals with a WAC below $35 and permits ads to note that consumer costs may differ based on insurance coverage. The Secretary of Health and Human Services must promulgate final regulations within one year of enactment to specify visual and audio disclosure formats across media and timelines for updating ads to reflect WAC changes; violations by manufacturers or their agents are subject to civil monetary penalties of up to $100,000 per violation.