Presidential DocumentExecutive Order 142932025-08267
Regulatory Relief To Promote Domestic Production of Critical Medicines
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 8, 2025
Signed
May 5, 2025
Issuing agencies
Executive Office of the President
Full Text
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<title>Federal Register, Volume 90 Issue 88 (Thursday, May 8, 2025)</title>
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[Federal Register Volume 90, Number 88 (Thursday, May 8, 2025)]
[Presidential Documents]
[Pages 19615-19617]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-08267]
Presidential Documents
Federal Register / Vol. 90 , No. 88 / Thursday, May 8, 2025 /
Presidential Documents
[[Page 19615]]
Executive Order 14293 of May 5, 2025
Regulatory Relief To Promote Domestic Production
of Critical Medicines
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. During my first term, my
Administration took unprecedented action to improve the
well-being of the American people by restoring capacity
for domestic production of critical pharmaceutical
products. Notably, in Executive Order 13944 of August
6, 2020 (Combating Public Health Emergencies and
Strengthening National Security By Ensuring Essential
Medicines, Medical Countermeasures, and Critical Inputs
Are Made In The United States), I directed each
executive department and agency involved in the
procurement of Essential Medicines, Medical
Countermeasures, and Critical Inputs to take a variety
of actions to increase their domestic procurement of
Essential Medicines, Medical Countermeasures, and
Critical Inputs, as defined in section 7 of that order,
and to identify vulnerabilities in our Nation's supply
chains for these products. Unfortunately, the prior
administration did too little to advance these goals.
Critical barriers and information gaps persist in
establishing a domestic, resilient, and affordable
pharmaceutical supply chain for American patients.
One key area of concern is the length of time it takes
to build pharmaceutical manufacturing facilities in the
United States today. New construction must navigate
myriad Federal, State, and local requirements ranging
from building standards and zoning restrictions to
environmental protocols that together diminish the
certainty needed to generate investment for large
manufacturing projects. For pharmaceutical
manufacturing, these barriers are heightened by
unannounced inspections of domestic manufacturers by
the Food and Drug Administration (FDA), which are more
frequent than such inspections at international
facilities. Industry estimates suggest that building
new manufacturing capacity for pharmaceuticals and
critical inputs may take as long as 5 to 10 years,
which is unacceptable from a national security
standpoint. Even expanding existing capacity or
modifying existing production lines to produce new or
different products requires extensive permitting and
regulatory approval, making it more difficult to
repurpose existing underutilized pharmaceutical
manufacturing capacity available domestically.
It is in the best interest of the Nation to eliminate
regulatory barriers to the domestic production of the
medicines Americans need. My Administration will work
to make the United States the most competitive nation
in the world for the manufacture of safe and effective
pharmaceutical products.
Sec. 2. Policy. It is the policy of the United States
that the regulation of manufacturing pharmaceutical
products and inputs be streamlined to facilitate the
restoration of a robust domestic pharmaceutical
manufacturing base.
Sec. 3. Streamlining Review of Domestic Pharmaceutical
Manufacturing by the Food and Drug Administration.
Within 180 days of the date of this order, the
Secretary of Health and Human Services, through the
Commissioner of Food and Drugs (FDA Commissioner),
shall review existing regulations and guidance that
pertain to the development of domestic pharmaceutical
manufacturing and shall take steps to eliminate any
duplicative or unnecessary requirements in such
regulations and guidance; maximize
[[Page 19616]]
the timeliness and predictability of agency review; and
streamline and accelerate the development of domestic
pharmaceutical manufacturing. The FDA Commissioner's
review shall encompass all regulations and guidance
that apply to the inspection and approval of new and
expanded manufacturing capacity, emerging technologies
that enable the manufacturing of pharmaceutical
products, active pharmaceutical ingredients, key
starting materials, and associated raw materials in the
United States. The FDA Commissioner shall:
(a) evaluate the current risk-based approach to
prior approval of licensure inspections, including when
such inspections are necessary, and seek to improve
upon this approach to ensure all required inspections
are prompt, efficient, and limited to what is necessary
to ensure compliance with the Federal Food, Drug, and
Cosmetic Act and other Federal law;
(b) identify and undertake measures necessary to
expand, as practicable, existing programs that provide
early technical advice before a facility is
operational;
(c) identify and undertake measures necessary to
improve enforcement of data reporting under section
510(j)(3) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360(j)(3)), including consideration of
publicly displaying the list of facilities, including
foreign facilities, that are not in compliance;
(d) provide clearer guidance regarding the
requirements or recommendations for site changes,
including moving production from a foreign to domestic
facility, and validation of new or updated components
necessary in manufacturing; and
(e) review and, as appropriate, seek to update any
other relevant compliance policies, guidance documents,
and regulations.
Sec. 4. Enhancing Inspection of Foreign Manufacturing
Facilities. Within 90 days of the date of this order,
the FDA Commissioner shall develop and advance
improvements to the risk-based inspection regime that
ensures routine reviews of overseas manufacturing
facilities involved in the supply of United States
medicines, which shall be funded by increased fees on
foreign manufacturing facilities to the extent
consistent with applicable law. Additionally, the FDA
Commissioner shall publicly disclose the annual number
of inspections that the FDA conducts on such foreign
facilities, with specific detail by country and by
manufacturer.
Sec. 5. Streamlining Review of Domestic Pharmaceutical
Manufacturing by the Environmental Protection Agency.
Within 180 days of the date of this order, the
Administrator of the Environmental Protection Agency
(EPA) shall take action to update regulations and
guidance that apply to the inspection and approval of
new and expanded manufacturing capacity of
pharmaceutical products, active pharmaceutical
ingredients, key starting materials, and associated raw
materials in the United States to eliminate any
duplicative or unnecessary requirements and maximize
the timeliness and predictability of agency review.
Sec. 6. Centralized Coordination of Environmental
Permits to Expand Domestic Pharmaceutical Manufacturing
Capacity. For purposes of 42 U.S.C. 4336a, the EPA
shall be the lead agency for the permitting of
pharmaceutical manufacturing facilities that require
preparation of an Environmental Impact Statement
pursuant to the National Environmental Policy Act of
1969, 42 U.S.C. 4321 et seq., unless that role is
assumed by another agency. The lead agency shall
designate a single point of contact within the agency
to coordinate with permit applicants. The Office of
Management and Budget shall coordinate with the lead
agency and with other relevant agencies and the Federal
Permitting Improvement Steering Committee, as needed,
to expedite the review and approval of relevant
permits.
Sec. 7. Streamlining Review of Domestic Pharmaceutical
Manufacturing by the United States Army Corps of
Engineers. Within 180 days of the date of this order,
the Secretary of the Army, acting through the Assistant
Secretary
[[Page 19617]]
of the Army for Civil Works, shall review the
nationwide permits issued under section 404 of the
Clean Water Act of 1972 (33 U.S.C. 1344) and section 10
of the Rivers and Harbors Appropriation Act of 1899 (33
U.S.C. 403) to determine whether an activity-specific
nationwide permit is needed to facilitate the efficient
permitting of pharmaceutical manufacturing facilities.
Sec. 8. 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.
<GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT>
(Presidential Sig.)
THE WHITE HOUSE,
May 5, 2025.
[FR Doc. 2025-08267
Filed 5-7-25; 11:15 am]
Billing code 4150-28-P
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</html>Indexed from Federal Register on May 8, 2025.
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