President Donald Trump signed an executive order Monday aimed at boosting domestic drug manufacturing in the U.S., as potential tariffs on imported pharmaceuticals draw closer. The order seeks to streamline FDA approvals and ease construction of new production facilities within the country.
Key Measures to Strengthen U.S. Pharmaceutical Production
The executive order instructs the Food and Drug Administration to accelerate approvals for new U.S.-based pharmaceutical plants by eliminating redundant steps, improving review timelines, and offering early support to manufacturers. It also mandates higher inspection fees for foreign drug facilities and tighter oversight of imported active pharmaceutical ingredients (APIs).
Domestic Drug Manufacturing Framed as National Security Priority
The White House stated that building new drug production capacity currently takes five to ten years — a timeline it described as unacceptable from a national security perspective. “We don’t want to be buying our pharmaceuticals from other countries,” Trump said. “We will produce our medical supplies, pharmaceuticals, and treatments right here in the United States.”
Regulatory and Enforcement Shifts Target Foreign Manufacturers
The FDA will increase both domestic and overseas inspections, shifting from scheduled visits abroad to surprise inspections. Commissioner Marty Makary highlighted disparities between domestic and foreign oversight, saying that U.S. facilities face stricter inspections than international competitors.
EPA and OMB Streamlining Permits for New U.S. Facilities
The executive order also instructs the Environmental Protection Agency to fast-track approvals for pharmaceutical infrastructure and calls for a single federal point-of-contact to coordinate permits, with support from the White House Office of Management and Budget.
Tariffs Loom as Industry Response Splits
The order precedes Trump’s plan to impose tariffs on pharmaceutical imports. Some companies like Eli Lilly and Johnson & Johnson have already expanded U.S. operations in anticipation. However, Pfizer CEO Albert Bourla expressed concern, warning that tariff threats discourage future domestic investment in research and production.
Global Supply Chains and Strategic Reshoring
With 73% of pharmaceutical imports in 2023 coming from Europe, the U.S. remains heavily reliant on overseas drug manufacturing, particularly for active ingredients. While reshoring could reduce supply disruptions, analysts warn it may also raise drug prices, affecting affordability.
Will domestic drug manufacturing efforts increase resilience without significantly raising healthcare costs — or will global supply chains continue to dominate?
