President Orders Fair Drug Prices Like in Europe—Finally!
Published Date: 5/15/2025
Presidential Document
Summary
Starting soon, Americans will pay the lowest prices for prescription drugs—just like other rich countries do! This change targets drug makers who charge U.S. patients way more than folks overseas. By making drug prices fairer, this order aims to save money for patients and the government, with new rules rolling out quickly.
Analyzed Economic Effects
6 provisions identified: 6 benefits, 0 costs, 0 mixed.
Administration Sets Most-Favored-Nation Targets
The Secretary of Health and Human Services must communicate most-favored-nation (MFN) price targets to drug manufacturers within 30 days of May 12, 2025. The goal is to bring U.S. drug prices in line with comparably developed nations by giving manufacturers specific MFN price targets.
Possible Importation Waivers to Cut Drug Costs
If MFN pricing progress is not achieved, the Secretary may consider certifying to Congress that importation under section 804(j) of the Federal Food, Drug, and Cosmetic Act poses no additional health risk and would result in a significant reduction in cost. If the Secretary certifies, the FDA Commissioner shall describe circumstances for consistently granting case-by-case waivers to import prescription drugs from developed nations with low costs.
Direct-to-Consumer Purchase Programs Enabled
To the extent allowed by law, the Secretary of Health and Human Services will facilitate direct-to-consumer purchasing programs for manufacturers that sell drugs to American patients at the most-favored-nation price. This is intended to let patients buy medicines directly at lower MFN prices when manufacturers participate.
Antitrust Enforcement Against Drug Industry Practices
Following a report required by an earlier executive order (the April 15, 2025 report), the Attorney General and the Federal Trade Commission shall, to the extent consistent with law, pursue enforcement against identified anti-competitive practices using tools like the Sherman Act and FTC Act. This action is part of the effort to address practices that contribute to high U.S. drug prices.
Trade Actions to Address Foreign Price Suppression
The Secretary of Commerce and the U.S. Trade Representative are directed to take necessary action to address foreign acts, policies, or practices that suppress pharmaceutical prices below fair market value or otherwise force U.S. patients to pay disproportionate shares of R&D costs. The order instructs review and action to counter such foreign policies.
FDA Review and Possible Revocation of Drug Approvals
The FDA Commissioner is directed to review and potentially modify or revoke approvals for drugs that may be unsafe, ineffective, or improperly marketed. This directs the agency to reconsider approvals where safety, effectiveness, or marketing issues are identified.
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