On May 5, 2025, President Trump signed an executive order designed to increase U.S. capacity to manufacture drugs domestically.
The order instructs the Food and Drug Administration (FDA) to:
- Reduce the time it takes to approve domestic pharmaceutical manufacturing plants by eliminating “duplicative and unnecessary” requirements, streamlining reviews and working with domestic manufacturers to provide early support before facilities come online.
- Increase fees for inspections of foreign manufacturing plants.
- Improve enforcement of active pharmaceutical ingredient source reporting by foreign drug producers and consider publicly displaying a list of facilities that do not comply.
In addition, the FDA will develop guidance for drugmakers to make site changes needed to move production from abroad to a domestic location and work to provide technical advice to companies before a facility is operational.
As part of this effort, the Environmental Protection Agency (EPA) is directed to accelerate the construction of facilities designed to manufacture prescription drugs, active pharmaceutical ingredients and other raw materials related to prescription drugs. The EPA will also be the lead agency charged with granting permits to facilities that require an environmental impact statement unless another agency steps in.
The executive order goes on to state that timelines to build new manufacturing capacity for pharmaceuticals and critical inputs may take up to five to ten years and that is unacceptable.
