DELIVERING MOST-FAVORED-NATION PRESCRIPTION DRUG
PRICING TO AMERICAN PATIENTS
Executive Orders, May 12, 2025
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.
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.
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.
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.
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.
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
Comments
Drug Prices will be lowered for US Consumers. Pharmaceutical Companies will no longer be able to charge US Consumers more for the Drugs they sell to other countries.
Norb Leahy, Dunwoody GA Tea Party Leader
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