[Federal Register Volume 90, Number 93 (Thursday, May 15, 2025)]
[Presidential Documents]
[Pages 20749-20751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-08876]
[[Page 20747]]
Vol. 90
Thursday,
No. 93
May 15, 2025
Part II
The President
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Executive Order 14297--Delivering Most-Favored-Nation Prescription Drug
Pricing to American Patients
Presidential Documents
Federal Register / Vol. 90 , No. 93 / Thursday, May 15, 2025 /
Presidential Documents
___________________________________________________________________
Title 3--
The President
[[Page 20749]]
Executive Order 14297 of May 12, 2025
Delivering Most-Favored-Nation Prescription Drug
Pricing to American 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.
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.
[[Page 20750]]
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.
[[Page 20751]]
(d) The Department of Health and Human Services
shall provide funding for publication of this order in
the Federal Register.
(Presidential Sig.)
THE WHITE HOUSE,
May 12, 2025.
[FR Doc. 2025-08876
Filed 5-14-25; 2:00 pm]
Billing code 4150-28-P