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. Throughout my initial term, my Administration has undertaken unprecedented measures to enhance the welfare of the American populace by revitalizing our capacity for domestic production of essential pharmaceutical products. In particular, via Executive Order 13944 dated 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 mandated that each executive department and agency involved in acquiring Essential Medicines, Medical Countermeasures, and Critical Inputs take myriad actions to boost their domestic procurement. This initiative also includes identifying vulnerabilities within our nation’s supply chains for these critical products. Regrettably, the previous administration fell short in advancing these objectives. Significant obstacles and gaps in information continue to undermine the establishment of a resilient, affordable pharmaceutical supply chain for American patients.
A major concern lies in the protracted timeline required to construct pharmaceutical manufacturing facilities on American soil today. New constructions must navigate an intricate web of Federal, State, and local regulations, ranging from building codes and zoning laws to environmental protocols, all of which collectively erode the certainty necessary for attracting investment in large manufacturing endeavors. Furthermore, for pharmaceutical manufacturing, these challenges are exacerbated by unannounced inspections from the Food and Drug Administration (FDA), which occur more frequently than at international facilities. Industry estimates indicate that establishing new manufacturing capacity for pharmaceuticals and critical inputs could take anywhere from 5 to 10 years—an outcome that is untenable from a national security perspective. Even efforts to expand existing capacity or adapt current production lines for new or different products are mired in extensive permitting and regulatory hurdles, complicating the repurposing of underutilized domestic pharmaceutical manufacturing capacity.
It is in the best interest of the Nation to dismantle regulatory barriers hindering the domestic production of the medicines Americans need. My Administration is committed to positioning the United States as the most competitive nation worldwide for the manufacture of safe and effective pharmaceutical products.
Sec. 2. Policy. The United States adopts a policy to streamline the regulation of pharmaceutical manufacturing and inputs to facilitate the revival of a robust domestic pharmaceutical manufacturing sector.
Sec. 3. Streamlining Review of Domestic Pharmaceutical Manufacturing by the Food and Drug Administration. Within 180 days of this order, the Secretary of Health and Human Services, through the FDA Commissioner, shall conduct a comprehensive review of existing regulations and guidance related to the development of domestic pharmaceutical manufacturing. The aim is to eliminate any redundant or unnecessary requirements, enhance the timeliness and predictability of agency reviews, and accelerate domestic pharmaceutical manufacturing development. This review will encompass all regulations and guidance pertaining to the inspection and approval of new and expanded manufacturing capacity, alongside emerging technologies that facilitate the production of pharmaceutical products, active pharmaceutical ingredients, key starting materials, and associated raw materials within the United States. The FDA Commissioner shall:
(a) examine the current risk-based approach to prior approval inspections, including the necessity of such inspections, and aim to enhance this approach to ensure that all required inspections are prompt, efficient, and limited to what is essential for compliance with the Federal Food, Drug, and Cosmetic Act and other Federal laws;
(b) identify and implement measures to expand existing programs that provide early technical advice prior to a facility becoming operational;
(c) determine necessary measures to enhance 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 the consideration of publicly disclosing a list of facilities, including foreign entities, that are non-compliant;
(d) offer clearer guidance on requirements or recommendations for site transitions, including shifting production from foreign to domestic facilities, and validation of new or updated components essential for 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 this order, the FDA Commissioner shall develop and advance improvements to the risk-based inspection regime that guarantees routine evaluations of overseas manufacturing facilities supplying medicines to the United States. This will be funded through increased fees imposed on foreign manufacturing operations, as permissible by law. Additionally, the FDA Commissioner will publicly disclose the annual number of inspections conducted on such foreign facilities, detailing specifics by country and by manufacturer.
Sec. 5. Streamlining Review of Domestic Pharmaceutical Manufacturing by the Environmental Protection Agency. Within 180 days of this order, the Administrator of the Environmental Protection Agency (EPA) shall update regulations and guidance applicable to the inspection and approval of new and expanded pharmaceutical manufacturing capacity, active pharmaceutical ingredients, key starting materials, and associated raw materials in the United States, aiming to eliminate duplicative or unnecessary requirements while maximizing the timeliness and predictability of agency reviews.
Sec. 6. Centralized Coordination of Environmental Permits to Expand Domestic Pharmaceutical Manufacturing Capacity. In accordance with 42 U.S.C. 4336a, the EPA will serve as the lead agency for permitting pharmaceutical manufacturing facilities that necessitate the preparation of an Environmental Impact Statement under 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 appoint a single point of contact within the agency for coordinating with permit applicants. The Office of Management and Budget will collaborate with the lead agency and other relevant entities, including the Federal Permitting Improvement Steering Committee, as needed, to expedite the review and approval process for relevant permits.
Sec. 7. Streamlining Review of Domestic Pharmaceutical Manufacturing by the United States Army Corps of Engineers. Within 180 days of this order, the Secretary of the Army, through the Assistant Secretary 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 necessary to streamline the permitting of pharmaceutical manufacturing facilities.
Sec. 8. General Provisions. (a) Nothing in this order shall be interpreted to impede or otherwise affect:
(i) the authority delegated 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 concerning budgetary, administrative, or legislative proposals.
(b) This order will be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order does not intend to, nor does it, create any enforceable rights or benefits, substantive or procedural, for any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other individual.
(d) The Department of Health and Human Services shall allocate funding for the publication of this order in the Federal Register.
DONALD J. TRUMP
THE WHITE HOUSE,
May 5, 2025.
