Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients
President Donald J. Trump issued an executive order to address the high cost of prescription drugs in the United States.
The order mandates that the government secure the lowest prices paid by other developed nations for pharmaceuticals.
To achieve this, it instructs various federal agencies—including the Secretaries of Commerce and Health and Human Services—to utilize a multi-pronged approach involving negotiations, potential rulemaking, and legal action against anti-competitive practices.
Failure by pharmaceutical companies to comply with the new pricing goals could trigger stricter regulatory measures, including direct-to-consumer sales facilitation at the most-favored-nation price and the possible certification to Congress for importation of lower-cost drugs from other developed countries.
The order also addresses potential legal and budgetary challenges related to its implementation.
Arguments For
Intended Benefit: Lower prescription drug costs for American consumers, reducing the financial burden on individuals and the healthcare system.
Evidence Cited: The order cites the significant price discrepancy between the US and other developed nations, suggesting unfair pricing practices by pharmaceutical manufacturers.
Implementation Methods: The order directs various federal agencies to take steps like negotiating most-favored-nation prices, facilitating direct-to-consumer purchasing, and potentially imposing regulations or taking legal action if drug manufacturers fail to lower prices.
Legal/Historical Basis: The order is based on the President's constitutional authority and existing laws related to drug pricing, healthcare, and antitrust enforcement.
Arguments Against
Potential Impacts: Drug manufacturers may reduce research and development spending due to lower profits, potentially slowing innovation. This could also impact drug availability.
Implementation Challenges: Negotiating most-favored-nation prices may be challenging internationally and possibly lead to diplomatic disputes. Regulatory changes and legal actions may face legal challenges and take time to implement.
Alternative Approaches: Other policies like increased generic competition, incentivizing price transparency, or negotiating bulk purchases for government health programs could be used to lower drug costs.
Unintended Effects: Price controls on prescription drugs may lead to shortages or limit access to cutting-edge medications for US patients.
By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered:
Section 1. Purpose. The United States has less than five percent of the world’s population and yet funds around three quarters of global pharmaceutical profits. This egregious imbalance is orchestrated through a purposeful scheme in which drug manufacturers deeply discount their products to access foreign markets, and subsidize that decrease through enormously high prices in the United States.
The United States has for too long turned its back on Americans, who unwittingly sponsor both drug manufacturers and other countries. These entities today rely on price markups on American consumers, generous public subsidies for research and development primarily through the National Institutes of Health, and robust public financing of prescription drug consumption through Federal and State healthcare programs. Drug manufacturers, rather than seeking to equalize evident price discrimination, agree to other countries’ demands for low prices, and simultaneously fight against the ability for public and private payers in the United States to negotiate the best prices for patients. The inflated prices in the United States fuel global innovation while foreign health systems get a free ride. This abuse of Americans’ generosity, who deserve low-cost pharmaceuticals on the same terms as other developed nations, must end. Americans will no longer be forced to pay almost three times more for the exact same medicines, often made in the exact same factories. As the largest purchaser of pharmaceuticals, Americans should get the best deal.
This section establishes the order's purpose: to address the significant disparity in prescription drug prices between the US and other developed countries.
The order highlights that the US disproportionately funds global pharmaceutical profits through high domestic prices that subsidize lower prices in foreign markets.
It frames this as an unfair burden on American consumers and calls for an end to this system.
Sec. 2. Policy. Americans should not be forced to subsidize low-cost prescription drugs and biologics in other developed countries, and face overcharges for the same products in the United States. Americans must therefore have access to the most-favored-nation price for these products.
My Administration will take immediate steps to end global freeloading and, should drug manufacturers fail to offer American consumers the most-favored-nation lowest price, my Administration will take additional aggressive action.
This section outlines the policy goal: to ensure that Americans have access to the lowest price paid in any other developed country (the "most-favored-nation" price) for prescription drugs and biologics.
It signals a commitment to taking action to achieve this goal, including more aggressive measures if drug manufacturers don't comply.
Sec. 3. Addressing Foreign Nations Freeloading on American-Financed Innovation. The Secretary of Commerce and the United States Trade Representative shall take all necessary and appropriate action to ensure foreign countries are not engaged in any act, policy, or practice that may be unreasonable or discriminatory or that may impair United States national security and that has the effect of forcing American patients to pay for a disproportionate amount of global pharmaceutical research and development, including by suppressing the price of pharmaceutical products below fair market value in foreign countries.
The Secretary of Commerce and the US Trade Representative are directed to investigate and take action against foreign countries whose policies or practices contribute to unfair drug pricing that burdens American patients and the US pharmaceutical research and development system.
This involves identifying and addressing unreasonable or discriminatory actions by foreign nations that impact drug prices.
Sec. 4. Enabling Direct-to-Consumer Sales to American Patients at the Most-Favored-Nation Price. To the extent consistent with law, the Secretary of Health and Human Services (Secretary) shall facilitate direct-to-consumer purchasing programs for pharmaceutical manufacturers that sell their products to American patients at the most-favored-nation price.
The Secretary of Health and Human Services is tasked with facilitating direct-to-consumer sales programs for pharmaceutical manufacturers who agree to sell their products in the US at the most-favored-nation price. This aims to make these lower-priced options more accessible to consumers.
Sec. 5. Establishing Most-Favored-Nation Pricing. (a) Within 30 days of the date of this order, the Secretary shall, in coordination with the Assistant to the President for Domestic Policy, the Administrator for the Centers for Medicare and Medicaid Services, and other relevant executive department and agency (agency) officials, communicate most-favored-nation price targets to pharmaceutical manufacturers to bring prices for American patients in line with comparably developed nations.
(b) If, following the action described in subsection (a) of this section, significant progress towards most-favored-nation pricing for American patients is not delivered, to the extent consistent with law: (i) the Secretary shall propose a rulemaking plan to impose most-favored-nation pricing; (ii) the Secretary shall consider certification to the Congress that importation under section 804(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) will pose no additional risk to the public’s health and safety and result in a significant reduction in the cost of prescription drugs to the American consumer; and if the Secretary so certifies, then the Commissioner of Food and Drugs shall take action under section 804(j)(2)(B) of the FDCA to describe circumstances under which waivers will be consistently granted to import prescription drugs on a case-by-case basis from developed nations with low-cost prescription drugs; (iii) following the report issued under section 13 of Executive Order 14273 of April 15, 2025 (Lowering Drug Prices by Once Again Putting Americans First), the Attorney General and the Chairman of the Federal Trade Commission shall, to the extent consistent with law, undertake enforcement action against any anti-competitive practices identified within such report, including through use of sections 1 and 2 of the Sherman Antitrust Act and section 5 of the Federal Trade Commission Act, as appropriate; (iv) the Secretary of Commerce, and the heads of other relevant agencies as necessary, shall review and consider all necessary action regarding the export of pharmaceutical drugs or precursor material that may be fueling the global price discrimination; (v) the Commissioner of Food and Drugs shall review and potentially modify or revoke approvals granted for drugs, for those drugs that maybe be unsafe, ineffective, or improperly marketed; and (vi) the heads of agencies shall take all action available, in coordination with the Assistant to the President for Domestic Policy, to address global freeloading and price discrimination against American patients.
This section details the plan to implement most-favored-nation pricing.
First, the Secretary of Health and Human Services (HHS) will communicate price targets to pharmaceutical manufacturers.
If sufficient progress isn't made, HHS will pursue various options, including proposing regulations to mandate most-favored-nation pricing, and potentially certifying to Congress for importation of less expensive drugs; legal action against anti-competitive practices; review of pharmaceutical exports and drug approvals; and broader action to combat global price discrimination.
Sec. 6. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise affect:
(i) the authority granted by law to an executive department or agency, or the head thereof; or (ii.) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person. (d) The Department of Health and Human Services shall provide funding for publication of this order in the Federal Register.
DONALD J. TRUMP
THE WHITE HOUSE, May 12, 2025.
This section includes general provisions clarifying that the order doesn't supersede existing legal authorities of government bodies or create any new legal rights or benefits.
Implementation is subject to existing laws and available funding.
The Department of Health and Human Services is responsible for formally publishing this order.