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Executive Order 14293
Regulatory Relief To Promote Domestic Production of Critical Medicines
Signed May 5, 2025, printed at 90 FR 19615. 7 sections of substance, 1,345 words.
This order eases rules on making key minerals at home. It aims to cut reliance on other lands.
Sec. 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
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
This is about making drugs here. It points back to a 2020 order. It says too many drugs are made abroad.
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.
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.
This sets the policy. Rules on drug plants should be simpler. The aim is more making done here.
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
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
This tells the FDA to review its rules. It must cut steps that repeat. The deadline is 180 days.
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.
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.
This is about plants abroad. The FDA must inspect them more often. Fees on those plants would pay for it.
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.
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.
This tells the EPA to review its rules. Plants that make drugs would face fewer steps. The deadline is 180 days.
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.
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.
This puts the EPA in charge of permits. That covers drug plants that need a full review. One contact would handle each case.
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.
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.
This is about water permits. The Army Corps must review them in 180 days. It must see if drug plants need their own permit.
Sec. 8. General Provisions
Every order carries this. It is not what the order does.
(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
(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
This is the closing clause that nearly every order carries. It says the order does not change what the law already allows. It also says no one can sue to enforce it.
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