S. 229 — DTC Act of 2025

This section states congressional findings on direct-to-consumer advertising of prescription drugs—including that it is permitted only in the United States and New Zealand; pharmaceutical ad spending exceeded $6 billion in 2018 (up 4.8% from 2017), with Americans seeing nine ads per day; the top advertised drug in 2020 had a list price over $6,000 per month; two-thirds of ads from 2016-2018 focused on 39 brand-name drugs or biologics (half recently FDA-approved); such ads drove nine times more prescriptions for new brand-name drugs and accounted for 58% of $560 billion in Medicare drug spending from 2016-2018 (with the top 20 TV-advertised drugs costing Medicare and Medicaid $34 billion in 2018 alone)—and expresses the sense of Congress that greater price transparency, including disclosure of wholesale acquisition cost (WAC), is needed to promote competition, enable informed consumer decisions, and reduce demand for higher-cost drugs.

This section establishes a requirement, effective July 1, 2026, that direct-to-consumer advertisements for prescription drugs or biological products covered under Medicare (title XVIII) or Medicaid (title XIX) of the Social Security Act—which already disclose side effects, contraindications, and effectiveness per FDA regulations—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 products with a WAC below $35 for such supply or course and permits ads to note that consumer costs may differ based on insurance. (WAC is the manufacturer's average price to wholesalers, excluding discounts, as defined in SSA section 1847A(c)(6)(B).) It directs the Secretary of Health and Human Services to promulgate final implementing regulations within one year of enactment, specifying visual and audio disclosure formats by medium and timelines for updating ads to reflect WAC changes. It authorizes civil money penalties of up to $100,000 per violation, enforceable via procedures in SSA section 1128A (other than subsections (a) and (b)), and such sums as necessary for implementation.