President Trump’s May 5, 2025, executive order titled “Regulatory Relief to Promote Domestic Production of Critical Medicines” sets out the administration’s goals to increase the domestic manufacture of critical pharmaceutical products. Painting its policy goals in broad strokes, the order emphasizes facilitating the rapid growth of a domestic pharmaceutical manufacturing base, accompanied by increased scrutiny of foreign facilities and the shifting of inspection costs to foreign manufacturers.
Streamlining Review of Domestic Pharmaceutical Manufacturing by the FDA
Consistent with the administration’s prior calls to reduce regulatory burdens, the executive order directs the Food and Drug Administration (FDA) to identify and eliminate regulations and guidance that may hinder the development of domestic pharmaceutical manufacturing. The FDA is required to evaluate its current risk-based approach to licensure inspections, expand existing programs that provide early technical advice before a facility becomes operational, improve data reporting, and clarify requirements for site changes, including when production is relocated from foreign to domestic facilities. Additionally, the FDA is tasked with improving guidance for the validation of new or updated manufacturing components and reviewing and updating relevant compliance policies and guidance documents.
Enhancing Inspection of Foreign Manufacturing Facilities
Parallel to its focus on increasing domestic manufacturing, the executive order seeks to discourage reliance on foreign manufacturing through increased inspections and cost-shifting to foreign sites. It tasks the FDA with risk-based inspection of overseas manufacturing facilities. However, the order is silent on the expected specifics of such “improvements” and does not identify any current deficiencies in the process. The cost of these inspections is to be met by increased fees on foreign manufacturing facilities, further disincentivizing foreign manufacturing of critical medicines. The annual number of inspections of foreign facilities must be disclosed by the FDA, with specific details by country and by manufacturer.
Streamlining Review by the EPA and Centralized Coordination of Environmental Permits
In addition to tasking the FDA with streamlining approval of domestic manufacturing, the executive order requires the Environmental Protection Agency (EPA) to act within 180 days to update regulations and guidance that apply to the inspection and approval of new and expanded manufacturing capacity of pharmaceutical products, and other components of the supply chain. The EPA is designated as the lead agency for the coordination and permitting of pharmaceutical manufacturing facilities that require the preparation of an environmental impact statement. To further streamline the process, a single point of contact must be identified within the EPA to interact with permit applicants. The Office of Management and Budget (OMB) is also required to coordinate with the agencies involved to expedite the review and approval of relevant permits.
Streamlining Review of Domestic Pharmaceutical Manufacturing by the U.S. Army Corps of Engineers
Finally, the executive order requires the secretary of the army, acting through the assistant secretary of the army for civil works, to review within 180 days 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.
Takeaways
The pharmaceutical and health care industries appear to be a particular focus of the Trump administration, with multiple executive orders issued to build up domestic manufacturing capacity, streamline regulations, and increase transparency in drug pricing. While the specifics are yet to be developed through notice and comment, and the ultimate effectiveness of regulatory streamlining remaining to be seen, these actions emphasize the administration’s focus on accessibility to health care and streamlining regulations to build up domestic industries.
