in effect
Executive Order 14297, signed May 12, 2025, directs federal agencies to pursue “most-favored-nation” pricing for prescription drugs sold in the United States — meaning Americans would pay no more than the lowest price any comparable developed country pays for the same drug. It sets a 30-day deadline for HHS to communicate price targets to drug manufacturers, with a series of escalating government actions if manufacturers do not comply voluntarily.
Within 30 days, HHS must formally notify pharmaceutical manufacturers of target prices benchmarked to what other wealthy nations pay. If manufacturers do not make significant progress toward those prices, HHS must propose a formal rulemaking to impose most-favored-nation pricing by regulation. Separately, HHS may certify that importing prescription drugs from developed countries poses no added safety risk, which would trigger a process allowing the FDA to grant case-by-case import waivers under existing law (FDCA Section 804(j)). The Department of Commerce and the U.S. Trade Representative are directed to take action against foreign government policies that suppress drug prices abroad, and the Attorney General and FTC are directed to pursue antitrust enforcement against any anti-competitive drug pricing practices identified in a prior April 2025 executive order. The Commerce Department must also review whether restricting pharmaceutical exports could address the international price gap.
Pharmaceutical manufacturers that sell drugs in the United States are the primary target, as the order pressures them to lower U.S. prices toward the lowest prices they charge in comparable foreign markets or face regulation, import competition, and antitrust scrutiny. American consumers — particularly Medicare and Medicaid beneficiaries, since CMS is directly involved in implementation — stand to benefit if prices fall, though the order creates no legally enforceable right for individuals. Foreign governments whose drug-pricing policies are characterized as suppressing prices below fair market value may face U.S. trade actions.