Regulatory Relief To Promote Domestic Production of Critical Medicines
Record date: 2025-05-08
( printed 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
What this record contains
- Federal Register document
- 2025-08267
- Publication date
- 2025-05-08
- Citation
- 90 FR 19615
- Issuing office
- Executive Office of the President
Official record excerpt
( printed 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 ( printed 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
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