The Trump Administration Seeks to Spur Domestic Drug Manufacturing with Regulatory Relief EO

On May 5, President Trump issued an Executive Order (EO) titled “Regulatory Relief to Promote Domestic Production of Critical Medicines,” with the stated purpose of eliminating “regulatory barriers to the domestic production of the medicines Americans need.” The EO establishes the policy that the regulation of manufacturing pharmaceutical products and inputs should be streamlined to support “the restoration of a robust domestic pharmaceutical manufacturing base” and identifies a series of actions to be carried out over the next six months by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and the United States Army in furtherance of this stated policy objective. The EO specifically mentions active pharmaceutical ingredients, key starting materials and associated raw material in the EPA action item. The EO’s key actions for FDA, EPA and the United States Army are outlined below.

FDA Actions

• The Secretary of Health and Human Services, through the FDA Commissioner, 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. (180-day timeline)

• The FDA Commissioner is directed to 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, funded by increased fees on foreign manufacturing facilities and the FDA Commissioner must publicly disclose the annual number of inspections that the FDA conducts on such foreign facilities. (90-day timeline)

EPA Action

• The EPA Administrator is instructed to 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. (180-day timeline)

Army Action

• The Secretary of the Army, acting 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 needed to facilitate the efficient permitting of pharmaceutical manufacturing facilities. (180-day timeline)

Next Steps

In recent years, Congress has engaged on policy issues related to domestic pharmaceutical manufacturing, including policy issues related to improving supply chain resiliency, preventing drug shortages, spurring onshoring of domestic pharmaceutical manufacturing and FDA’s inspection of foreign drug manufacturing facilities. These have also been areas of focus for many stakeholders given their importance to patients, public health, health providers and various pharmaceutical industry stakeholders. The issuance of this latest EO is timely as the Fiscal Year (FY) 2026 budget and appropriations process is getting underway and is often a season in which various administration officials testify before Congress on a range of issues, including the Commissioner of Food and Drugs.

Certain of the initiatives identified have already been a focus of agency consideration, such as FDA’s efforts to support advanced manufacturing and to tailor risk-based inspections. Other initiatives, such as increasing fees on foreign drug manufacturing facilities, would potentially require new statutory authority or statutory amendments. Facility fees, as well as timeliness and predictability of reviews, would typically be core topics in user fee negotiations, with the next negotiation cycle on tap to develop recommendations for the October 1, 2027, reauthorization.

Stakeholders will be watching for additional details from the administration regarding implementation of the EO in the weeks and months ahead, including Congress potentially engaging on this latest EO as part of the FY26 budget and appropriations process and given the prior work on related policy fronts. Notably, the day after this EO was issued, FDA announced plans to expand unannounced inspections at foreign manufacturing facilities.