Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing

United States President Donald Trump has signed an executive order containing several directives to FDA and the Environmental Protection Agency (EPA), aiming to reduce regulatory barriers and restore a robust domestic manufacturing base for prescription drugs (1).

According to a Fact Sheet issued by the White House on May 5, 2025, the order directs FDA to take several steps to reduce the time needed to approve pharmaceutical manufacturing plants located in the US, including eliminating “duplicative and unnecessary” requirements—although, the fact sheet did not clarify what those requirements are—streamlining the review process, and working with domestic manufacturers to offer early support before a facility comes online (1).

Additionally, FDA is being instructed to increase fees for, and inspections of, foreign manufacturing plants, and to improve enforcement of API source reporting by foreign drug producers (1). The administration suggests displaying a public list of those facilities that do not comply.

FDA on May 6 announced an intention to expand unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and certain other products (2).

“For too long, foreign companies have enjoyed a double standard—given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today,” FDA Commissioner Martin A. Makary, MD, said (2). “This is a key step for FDA as part of a broader strategy to get foreign inspections back on track.”

Regarding the EPA, the Trump Administration is calling for the acceleration of construction of facilities designed to manufacture prescription drugs, APIs, and any other raw materials necessary. The White House said critical gaps exist in the creation of an affordable and resilient domestic pharmaceutical supply chain, and that current estimates of five to 10 years for building new manufacturing capacity are “unacceptable” in terms of national security (1).

Bio/pharmaceutical companies either headquartered in the US or with major operations within the country have been weighing the potential impacts of the Trump Administration’s tariff policies since the 47th president re-took office in January 2025, with an expectation that the bio/pharma industry will be impacted sooner or later, one way or another (3). Many companies and executives are feeling uncertain about the outcome, or taking a wait-and-see approach (4).

Some companies have been proactive. In February 2025, Eli Lilly and Company announced that it would be building four new domestic manufacturing sites in the United States, saying that the Tax Cuts and Jobs Act, passed in 2017 during the prior Trump Administration, was the impetus for the company’s decision to expand nationally (5).

The May 5 executive order, the fact sheet said, builds on actions taken in Trump’s first term to reshore production of essential medicines and reduce American reliance on foreign drug producers (1).

“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,” President Trump said, as quoted in the fact sheet. “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.”

The May 6 FDA action aligns with the sentiments of the fact sheet, which said that the executive order is designed to ensure FDA prioritizes American manufacturing facilities over foreign ones (1).

“This change builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program in India and China and aims to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies,” FDA’s press release said (2).

Under terms of the May 5 executive order, federal agencies that issue permits for domestic pharmaceutical manufacturing facilities are being directed to designate a single point-of-contact for permit applications with interagency support from the White House Office of Management and Budget to ensure the most efficient process (1).

References

1. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Reduce Regulatory Barriers to Domestic Pharmaceutical Manufacturing. WhiteHouse.gov, May 7, 2025.
2. FDA. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. Press Release. May 6, 2025.
3. Bigica, A. Pharmaceutical Tariffs Are Imminent: How Industry is Bracing for Impact. PharmTech.com, April 16, 2025.
4. Lavery, P. Tariff Pause Reinforces Uncertainty Among Biopharma Professionals. PharmTech.com, April 10, 2025.
5. Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025.