Regulate the Price of All Drugs Act
- Bill Number
- H.R. 9040
- Origin Chamber
- House
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-05-26: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Financial Services, 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.
- Last Updated
- 2026-06-26T14:03:04Z
AI-Generated Summary
Purpose of the Legislation This bill establishes a federal system to set and enforce "fair prices" for all approved prescription drugs sold in the United States, beginning in 2027. Its stated goal is to ensure manufacturers provide drugs at these prices to patients, pharmacies, hospitals, and other providers.
Key Provisions
- Creation of the Prescription Drug Price Regulatory Commission: A 13-member body (7 presidential appointees and 6 ex officio members from federal health agencies) recommends fair prices for each drug. Recommendations must consider production and distribution costs, cost-effectiveness (including quality-adjusted life years), expected demand, research and development expenses with return on investment, average prices in reference countries (Canada, France, Germany, Italy, Japan, United Kingdom), and other factors specified by the Secretary of Health and Human Services.
- Fair Price Setting and Publication: The Secretary of Health and Human Services publishes annual fair prices by July 1 of the prior year, based on Commission recommendations. Prices can be revised mid-year for supply/demand changes or other factors, with 30 days' notice to manufacturers. Temporary 90-day (extendable) waivers are allowed if needed to maintain access.
- Enforcement and Penalties: Manufacturers must offer the fair price or face civil penalties equal to 10 times the difference between the charged price and the fair price, multiplied by units sold. The Federal Trade Commission treats violations as unfair practices. States and private individuals may sue for injunctions, damages (up to three times actual losses or $50,000 per violation), and attorney fees.
- Patent March-In Rights: The Secretary may license patents on a nonexclusive, partially exclusive, or exclusive basis if a drug is sold above the fair price or supply is inadequate.
- Defense Production Act Authority: The President may direct increased domestic manufacturing if the Commission finds insufficient U.S. production capacity and unreliable foreign imports.
- Scope: Covers most prescription drugs, biologics, insulin, associated supplies, and vaccines. Applies to all individuals in the United States.
Significant Changes to Existing Law
- Adds a new prohibition in the Federal Food, Drug, and Cosmetic Act against selling drugs above the published fair price.
- Introduces a new regulatory commission outside standard advisory committee rules.
- Creates federal price controls with civil penalties, state enforcement, and a private right of action, expanding beyond current Medicare negotiation or Medicaid rebate mechanisms.
- Authorizes patent licensing and Defense Production Act interventions specifically tied to drug pricing and supply.
Potential Impacts
- Government Agencies: Expands roles for HHS, FTC, and agencies like CMS, FDA, and CDC in price setting and enforcement; may require new administrative resources.
- Citizens: Aims to lower out-of-pocket drug costs for patients but could affect drug availability if manufacturers reduce supply or exit markets.
- International Relations: References prices in six foreign countries, potentially influencing global pricing strategies or trade discussions.
- Manufacturers: Faces mandatory pricing, penalties, and possible patent licensing, which may alter investment decisions in research and development.
Main Stakeholders Affected
- Prescription drug manufacturers and patent holders.
- Patients, pharmacies, hospitals, physicians, and other providers.
- Federal agencies (HHS, FTC, VA, DoD, CDC, FDA).
- State attorneys general.
- Consumers and advocacy groups.
Notable Legal, Constitutional, or Political Implications
- Raises questions about federal authority over private pricing and potential conflicts with patent rights under the Constitution's intellectual property clause.
- Creates new enforcement mechanisms involving FTC, states, and private lawsuits, which could lead to increased litigation.
- Uses existing authorities (Defense Production Act, march-in rights) in a novel pricing context.
- Applies uniformly to all approved drugs without exemptions for certain therapies or small manufacturers.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Recent Actions
- 2026-05-26: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Financial Services, 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.
- 2026-05-26: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Financial Services, 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.
- 2026-05-26: Referred to the Committee on Energy and Commerce, and in addition to the Committees on the Judiciary, and Financial Services, 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.
- 2026-05-26: Introduced in House
- 2026-05-26: Introduced in House
Bill Versions
- Regulate the Price of All Drugs Act — issued 2026-05-26 — PDF (17 pages)