Global Fairness in Drug Pricing Act
- Bill Number
- H.R. 3493
- Origin Chamber
- House
- Congress
- 119th Congress, Session 1
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2025-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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
- 2026-02-25T09:06:15Z
AI-Generated Summary
Purpose
The Global Fairness in Drug Pricing Act (H.R. 3493) aims to lower prescription drug prices in the United States by aligning them with prices in other comparably developed countries, addressing the disparity where U.S. patients often pay significantly more for the same medications.
Key Provisions
- Most-Favored-Nation Price Targets: Within 30 days of enactment, the Secretary of Health and Human Services (HHS), in coordination with the Centers for Medicare & Medicaid Services (CMS) and other federal agencies, must propose a rulemaking plan to set price targets for pharmaceutical manufacturers. These targets would ensure U.S. prices for drugs are comparable to those in similar developed nations (a "most-favored-nation" approach, meaning the U.S. gets pricing at least as favorable as the best rates abroad).
- Individual Drug Importation: The HHS Secretary must certify to Congress that allowing personal importation of prescription drugs under existing law (Section 804(j) of the Federal Food, Drug, and Cosmetic Act) poses no public health or safety risks and would significantly reduce costs for American patients. The Secretary must then outline and consistently grant case-by-case waivers for individuals to import drugs from countries with lower prices.
- Enforcement Against Anticompetitive Practices: The Attorney General and the Chair of the Federal Trade Commission (FTC) must take legal action against pharmaceutical manufacturers engaging in anticompetitive behaviors, using tools like the Sherman Act (which prohibits monopolies and price-fixing) and the FTC Act (which bans unfair competition).
- Direct-to-Consumer Purchasing Programs: HHS must promote programs allowing patients to buy drugs directly from manufacturers at the prices set by the new rulemaking, to the extent allowed by current laws.
- Study on Manufacturer Behaviors: The Secretary of Commerce and the U.S. Trade Representative must investigate whether pharmaceutical companies' actions—such as suppressing prices abroad or forcing U.S. patients to subsidize global research—are unreasonable, discriminatory, or harmful to national security. A report with findings must be submitted to Congress within 180 days of enactment.
Significant Changes to Existing Law
- Introduces mandatory price benchmarking against international rates, which is not currently required under U.S. drug pricing laws like those governing Medicare.
- Expands personal importation options by requiring certifications and consistent waivers, building on but activating underused provisions of the Federal Food, Drug, and Cosmetic Act that previously faced barriers due to safety concerns.
- Strengthens antitrust enforcement specifically targeting drug manufacturers, without creating new laws but directing aggressive use of existing ones (e.g., Sherman Act Sections 1 and 2).
- Adds a new federal study requirement on trade and pricing practices, which could inform future regulations but does not immediately alter trade laws.
Potential Impacts
- On Citizens: Could significantly reduce out-of-pocket costs for prescription drugs, benefiting millions of patients, particularly those on fixed incomes or relying on programs like Medicare and Medicaid, by enabling cheaper imports and enforced lower prices.
- On Government Agencies: Increases workload for HHS, CMS, FTC, Attorney General's office, Commerce Department, and U.S. Trade Representative, including rulemaking, certifications, enforcement, and reporting, potentially straining resources but aiming for long-term savings in federal health spending.
- On International Relations: May pressure foreign governments and drug markets by benchmarking U.S. prices to theirs, potentially leading to trade tensions if seen as interfering with other countries' pricing decisions; could also encourage global alignment on drug affordability.
- On Pharmaceutical Industry: Manufacturers may face revenue losses from capped prices and increased scrutiny, possibly slowing innovation or shifting production, but could foster more competition through enforcement actions.
Main Stakeholders Affected
- Patients and Consumers: Primary beneficiaries through lower drug costs and easier access via imports or direct purchases.
- Pharmaceutical Manufacturers: Directly regulated, facing price controls, enforcement risks, and study scrutiny that could expose practices like international price suppression.
- Federal Agencies: HHS, CMS, FTC, Department of Justice, Department of Commerce, and U.S. Trade Representative, tasked with implementation, enforcement, and analysis.
- Healthcare Providers and Insurers: Indirectly impacted by potential cost savings in drug supply chains, affecting reimbursement and coverage decisions.
- Congress: Receives certifications and reports, influencing future oversight or adjustments to the law.
- Foreign Governments and International Pharma Markets: Affected by U.S. benchmarking and importation, potentially altering global drug pricing dynamics.
Notable Legal, Constitutional, or Political Implications
- Legal: The bill relies on existing authorities (e.g., rulemaking under HHS, antitrust laws) but could invite challenges from manufacturers on grounds like takings (government limiting profits) or preemption of state laws; importation provisions must balance safety certifications to avoid violating federal drug safety standards.
- Constitutional: No direct conflicts noted, but enforcement actions could raise due process concerns if seen as arbitrary; the international benchmarking might touch on Commerce Clause issues regarding interstate and foreign trade regulation.
- Political: Bipartisan sponsorship (from both parties) signals broad appeal for affordability, but could spark debate over government intervention in markets versus free enterprise; the study on "subsidizing global R&D" may fuel discussions on U.S. innovation leadership and trade fairness without overt partisanship in the text.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Cosponsors (7)
Rep. Luna, Anna Paulina [R-FL-13], Rep. Kaptur, Marcy [D-OH-9], Rep. Biggs, Andy [R-AZ-5], Rep. Crane, Elijah [R-AZ-2], Rep. Greene, Marjorie Taylor [R-GA-14], Rep. Subramanyam, Suhas [D-VA-10], Rep. Barrett, Tom [R-MI-7]
Recent Actions
- 2025-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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.
- 2025-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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.
- 2025-05-19: Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and the Judiciary, 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.
- 2025-05-19: Introduced in House
- 2025-05-19: Introduced in House
Bill Versions
- Global Fairness in Drug Pricing Act — issued 2025-05-19 — PDF (4 pages)