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Text as it was Introduced in House
June 5, 2025
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House Votes

Pending Committee
June 5, 2025 (8 months ago)

Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.

Senate Votes

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Presidential Signature

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United StatesHouse Bill 3789HR 3789

DTC Act of 2025

Health
  1. house

Sponsors (9)

  • senate
  • president
  • Last progress June 5, 2025 (8 months ago)

    Introduced on June 5, 2025 by David J. Taylor

    Amendments

    No Amendments

    Related Legislation

    AI Insights

    Analyzed 2 of 2 sections

    Summary

    Requires many direct-to-consumer advertisements for prescription drugs and biological products covered by Medicare or Medicaid to display the drug’s wholesale acquisition cost (WAC) or typical 30‑day price. Products with a 30‑day WAC under $35 are exempt. The Department must issue a final rule within one year of enactment and ads must comply by July 1, 2026; manufacturers who do not comply may face civil money penalties up to $100,000 per violation.

    Key Points

    • Requires many direct-to-consumer prescription drug ads for Medicare/Medicaid‑covered products to display wholesale acquisition cost (WAC).
    • Products with a 30‑day (or typical course) WAC under $35 are exempt.
    • HHS must issue final regulations within one year; ads must comply by July 1, 2026.
    • Manufacturers face civil money penalties up to $100,000 per violation for noncompliance.
    • Focuses on list price (WAC) disclosure, not negotiated or out‑of‑pocket prices.
    • Aims to increase price transparency and reduce wasteful federal spending on high‑cost drugs.
    • Will require manufacturers and advertisers to update ad content and compliance systems to reflect WAC changes.
    • Details on format, placement, and exceptions will be set through HHS rulemaking.

    Categories & Tags

    Agencies
    Centers for Medicare & Medicaid Services
    HHS
    FDA
    American Medical Association
    Secretary (Department of Health and Human Services)
    Affected Groups
    Drug manufacturers (drug manufacturers and applicants)

    Provisions

    35 items

    Only the United States and New Zealand legally allow direct-to-consumer advertising of prescription drugs among developed countries.

    finding
    Affects: Consumers; pharmaceutical advertisers

    In 2018, pharmaceutical advertising spending exceeded $6,046,000,000, a 4.8% increase over 2017, and the average American saw about 9 drug ads per day.

    finding
    $6BEffective: 2018-01-01Affects: General public/consumers

    The most commonly advertised medication in the U.S. in 2020 had a list price of more than $6,000 for a one‑month supply.

    finding
    $6KEffective: 2020-01-01Affects: Consumers; patients

    A 2021 GAO report found that two‑thirds of direct‑to‑consumer drug advertising (2016–2018) was concentrated among 39 brand‑name drugs or biologics, about half of which were recently FDA‑approved.

    finding
    Affects: Advertised brand‑name drugs; consumers

    A 2011 CBO report found that manufacturers use direct‑to‑consumer advertising to boost demand and raise the price consumers will pay, increase quantity sold, or both.

    finding
    Affects: Pharmaceutical manufacturers; consumers
    IllinoissenatorRichard Joseph Durbin
    S-229 · Bill

    DTC Act of 2025

    1. senate
    Consumers
    Medicare Beneficiaries
    PDP sponsors and Medicare Advantage organizations offering MA–PD plans
    +2 more
  • house
  • president
  • Updated 1 day ago

    Last progress January 23, 2025 (1 year ago)

    Impact Analysis

    Who is affected and how:

    • Drug manufacturers and advertisers: Directly affected. They must modify ad content and compliance processes to display WAC for covered products above the $35 threshold. This may require new review workflows, creative redesign, and ongoing price updates.

    • Consumers and patients (including Medicare beneficiaries): Will see list price information in many DTC ads, which may influence consumer choices and spur price conversations. Because WAC is a list price, it may not reflect actual out‑of‑pocket costs for all individuals.

    • Federal programs (Medicare and Medicaid): Indirectly affected. The Congress findings state the policy aims to reduce wasteful federal spending by improving consumer decisionmaking; any spending effects would depend on whether transparency changes prescribing or utilization.

    • Advertising industry and media platforms: Must accommodate new ad content requirements and ensure compliance across mediums (TV, print, online). Digital platforms may need mechanisms to display or verify price statements.

    • Regulators (HHS): Must complete rulemaking in one year, interpret formatting/placement requirements, define compliance standards, and handle enforcement and penalties.

    Potential effects and tradeoffs:

    • Transparency: Listing WAC increases visibility of list prices but may not reflect negotiated discounts, rebates, or individual patient cost sharing, which could confuse some consumers.
    • Compliance costs: Manufacturers and ad agencies will incur design and compliance expenses and possible legal risk for errors.
    • Market behavior: If consumers react to displayed WACs, manufacturers may change pricing or marketing strategy; prescribers could face new patient questions about price.

    Net result: The bill establishes a straightforward transparency requirement with targeted scope (Medicare/Medicaid covered products above $35) and clear timelines and penalties, shifting compliance burden primarily to manufacturers and regulators while aiming to give consumers more price information.