Regulatory Relief To Promote Domestic Production of Critical Medicines

The order directs three agencies to review and reduce regulatory burdens on domestic pharmaceutical manufacturing. The FDA Commissioner must, within 180 days, eliminate duplicative or unnecessary inspection and approval requirements, improve early technical advice to facilities before they open, and provide clearer guidance on site changes such as moving production from foreign to domestic locations. Within 90 days, the FDA must also improve the risk-based inspection regime for foreign manufacturing facilities supplying U.S. medicines and publicly disclose inspection counts by country and manufacturer. The EPA must, within 180 days, update regulations and guidance for approving new or expanded pharmaceutical manufacturing capacity. The Army Corps of Engineers must, within 180 days, review whether a new activity-specific nationwide permit is needed to speed permitting of pharmaceutical plants.

The order designates EPA as the lead agency for environmental impact permitting of pharmaceutical manufacturing facilities under NEPA and requires a single point of contact for permit applicants. OMB is directed to coordinate with the lead agency and the Federal Permitting Improvement Steering Council to expedite permit review. The order does not itself change any existing regulation — all actual changes depend on future agency action and rulemaking.

Domestic and foreign pharmaceutical manufacturers and investors, FDA-regulated drug and ingredient facilities, applicants seeking federal environmental permits for new pharmaceutical plants, and American patients who depend on a resilient domestic drug supply chain.

Builders of domestic drug factories currently face a 5-to-10-year permitting and approval timeline. If agencies follow through, developers could face fewer duplicative inspections, faster permit approvals, and clearer guidance on moving production to the U.S. — potentially lowering costs and improving drug availability over time.

The order sets a two-track implementation arc. On the 90-day track, FDA must develop improvements to foreign-facility inspections funded by fees on those facilities and disclose inspection data publicly. On the 180-day track, FDA, EPA, and Army Corps each conduct separate regulatory reviews and take steps to eliminate duplicative requirements. EPA simultaneously assumes lead-agency status for NEPA permitting, with OMB providing cross-agency coordination. No enforcement mechanism is specified; actual regulatory changes require notice-and-comment rulemaking beyond the order's scope.