News Brief: President Trump Plans Actions to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
On May 5, 2025, President Donald J. Trump signed an Executive Order to incentivize robust drug manufacturing in the U.S. for prescription
drugs, including important ingredients and other key materials required to manufacture prescription drugs. This Executive Order comes ahead of Trump’s planned tariffs on drugs imported into the U.S.
The Executive Order directs the U.S Food and Drug Administration to limit the amount of time it takes approving 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”, according to a White House fact sheet (1). In the fact sheet, it states that the Executive Order also directs the following:
- Increase inspection fees for and inspections of foreign manufacturing plants.
- Improve its enforcement of pharmaceutical ingredient source reporting by foreign drug producers and publicly listing facilities that do not comply.
- Accelerate the Environmental Protection Agency’s construction of facilities designed to manufacture prescription drugs, active pharmaceutical ingredients and other necessary raw materials.
- Ensure federal agencies involved in permitting domestic pharmaceutical manufacturing facilities to appoint a single point of contact, who will coordinate the permitting process with support from the White House Office of Management and Budget, promoting a streamlined and unified approach.
Trump particularly mentioned the national security implications of relying on foreign pharmaceutical sources, stating, “We don’t want to be buying our pharmaceuticals from other countries because if we’re in a war, we’re in a problem, we want to be able to make our own.” Trump added, “As we invest in the future, we will permanently bring our medical supply chains back home. We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States.”