On May 5, 2025, President Donald Trump signed an Executive Order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines.” The administration also released a Fact Sheet related to the same. The Executive Order (EO) is intended to “eliminate regulatory barriers to the domestic production of the medicines Americans need” and “restor[e] capacity for domestic production of critical pharmaceutical products.” In so doing, the EO invokes EO 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)” pursuant to which FDA issued its list of essential medicines.
The May 5th EO indicates that it is animated by concerns with the time it takes to build, expand, or modify pharmaceutical manufacturing facilities in the United States today and the dampening impact this has on investment in large manufacturing projects. The EO notes that “[i]ndustry estimates suggest that building new manufacturing capacity for pharmaceuticals and critical inputs may take as long as 5 to 10 years.” According to the EO, this is “unacceptable from a national security standpoint.” The EO cites the “extensive” permitting and regulatory approvals required for such projects, including building standards and environmental protocols, as well as the “barriers” created by unannounced FDA inspections of domestic facilities, which it notes occur more frequently than such inspections at foreign facilities. It goes on to set as policy “that the regulation of manufacturing pharmaceutical products and inputs be streamlined to facilitate the restoration of a robust domestic pharmaceutical manufacturing base.” The EO then outlines several specific actions to be taken by FDA, EPA, the Army Corps of Engineers, and the Office of Management and Budget to implement this policy.
Food & Drug Administration
By November 1, 2025 – Within 180 days, the Commissioner of FDA is directed to “review existing regulations and guidance that pertain to the development of domestic pharmaceutical manufacturing” and “take steps to eliminate any duplicative or unnecessary requirements in such regulations and guidance,” “maximize the timeliness and predictability of agency review,” and “streamline and accelerate the development of domestic pharmaceutical manufacturing.”
- Scope. The review must “encompass all regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity,” as well as regulations and guidance that apply to “emerging technologies that enable the manufacturing of” pharmaceutical products, APIs, key starting materials, and associated raw materials in the United States.
- Specific Tasks. The FDA Commissioner is directed to:
- Evaluate the current risk-based approach to pre-approval / pre-licensure inspections (PAIs/PLIs), including with respect to when such inspections are necessary, and seek to make them more prompt, efficient, and limited to what is “necessary” to ensure compliance with federal law, including the FDCA;
- Expand, as practicable, FDA’s existing program to provide early technical advice to manufacturers before a pharmaceutical manufacturing facility is operational;
- Improve the enforcement of drug manufacturing volume data reporting under FDCA 510(j)(3) (21 U.S.C. 360(j)(3)) and consider publicly displaying a list of facilities that are out of compliance with these requirements, including foreign facilities;
- Clarify guidance on the requirements or recommendations for site changes, including specifically the relocation of production from foreign to domestic sites, and validation of new or updated components necessary in manufacturing; and
- Update any other relevant compliance policies, guidance documents, and/or regulations.
- By August 3, 2025 – Within 90 days, the Commissioner of FDA is directed to:
- Develop and advance improvements to its risk-based approach to inspections of foreign manufacturing facilities. These improvements are to be funded by increased fees on foreign manufacturing facilities, to the extent consistent with applicable law.
- Publicly disclose the annual number of inspections that it conducts of such foreign manufacturing facilities, with specific detail “by country and by manufacturer.”
Environmental Protection Agency
By November 1, 2025 – Within 180 days, the EPA Administrator is directed 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, with the goal of “eliminat[ing] any duplicative or unnecessary requirements and maximiz[ing] the timeliness and predictability of agency review.”
EPA is also designated as the default 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., (NEPA), unless that role is assumed by another agency. The lead agency for these purposes is also directed to designate a single point of contact within the agency to coordinate with permit applicants.
Office of Management & Budget
For purposes of permitting pharmaceutical manufacturing facilities that require preparation of an Environmental Impact Statement pursuant to the NEPA, the Office of Management and Budget is directed to 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.
Army Corps of Engineers
By November 1, 2025 – Within 180 days, the Assistant Secretary of the Army for Civil Works is directed to “determine whether an activity-specific nationwide permit is needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities.”
- The nationwide permits referenced in this directive are those 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).
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It remains to be seen how the relevant agencies will implement these directives. For example, the EO does not specifically define the types of “emerging technologies” regulations and guidance that are to be included within FDA’s review. It also is not immediately apparent how FDA can collect increased fees for foreign facility inspections under existing law, and the information on foreign inspections to be disclosed is generally already being provided on FDA’s website. But the EO does amplify concerns that some entities in the pharmaceutical manufacturing space have raised for years, including the growing scope of PAIs/PLIs, the need to accommodate new technologies that carry the potential to rapidly advance pharmaceutical development, and the difficulties in converting production lines to produce new or different products and expand capacity. And while an increase in enforcement of FDCA 510(j)(3) is unlikely to facilitate domestic manufacturing, it could allow FDA to better target enforcement actions against foreign facilities by improving FDA’s understanding of the sourcing of drugs internationally.
In the wake of recent reductions in staffing, agencies may experience challenges in implementing these directives rapidly. But some have already begun taking action. On May 6, 2025, FDA announced that it would be expanding its use of unannounced inspections at foreign manufacturing facilities and taking other steps to “improve[] [its] foreign inspection program to ensure that the FDA is the gold standard for regulatory oversight,” steps that appear to be a direct response to this executive order.
We will continue monitoring agency activity in response to the EO and potential opportunities for input on the process.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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