DTC Act of 2025
The Drug-price Transparency for Consumers Act of 2025 (DTC Act of 2025) would add a new requirement to title XI of the Social Security Act. Starting by July 1, 2026, direct-to-consumer advertisements for prescription drugs and biological products that are paid for by Medicare or Medicaid would have to include an appropriate disclosure of pricing information. The disclosure must center on the wholesale acquisition cost (WAC) for a 30-day supply or typical course of treatment, and may note that out-of-pocket costs can differ based on a consumer’s insurance. An exemption applies to drugs with a WAC under $35 for a 30-day supply. The bill directs the Secretary to issue implementing regulations within one year of enactment, establish how pricing information appears across ad media and how often ads can be updated when WAC changes, and provides civil penalties (up to $100,000 per violation) for noncompliance, along with public reporting and other enforcement tools. The measure includes definitions for key terms and authorizes funding to carry out the provisions. Overall, the bill seeks to increase price transparency in drug advertising to help consumers understand potential costs before initiating a therapy, with the goal of promoting informed purchasing decisions and potentially moderating federal spending on prescription drugs. It creates a regulatory framework, penalties for violations, and an enforcement pathway, while exempting the least expensive drugs from the requirement.
Key Points
- 1Adds new Sec. 1150D to Title XI to require pricing disclosures in direct-to-consumer ads for prescription drugs and biological products paid for by Medicare/Medicaid.
- 2Compliance deadline: by July 1, 2026; exemptions for drugs with a 30-day WAC under $35.
- 3Pricing disclosure content: must clearly disclose the wholesale acquisition cost for a 30-day supply or typical course; may note that consumer payment can vary based on insurance coverage.
- 4Rulemaking: Secretary must issue final regulations within 1 year, covering visual/audio presentation in each ad medium and how often ads can be updated to reflect WAC changes.
- 5Sanctions and enforcement: civil monetary penalties up to $100,000 per violation; enforcement aligned with the CMP framework (1128A) and public reporting of noncompliance; appropriations authorized to implement the section.