in effect
This is a presidential executive order (EO 14293, signed May 5, 2025) directing federal agencies to reduce regulatory hurdles for companies that manufacture pharmaceuticals and drug ingredients inside the United States. It does not itself change any law or regulation — it sets deadlines and instructions for the FDA, EPA, Army Corps of Engineers, and the Office of Management and Budget to review and revise their existing rules.
Within 90 days, the FDA must improve its inspection program for foreign drug manufacturing facilities and begin publicly reporting how many inspections it conducts overseas, broken down by country and company; those inspections are to be funded by higher fees charged to foreign manufacturers. Within 180 days, the FDA must review all regulations and guidance covering domestic pharmaceutical plant construction, expansion, and approval — eliminating duplicate or unnecessary requirements, making inspection timelines faster and more predictable, offering earlier technical guidance to companies before a facility opens, and clarifying what paperwork is needed when production moves from a foreign to a domestic site. On the same 180-day clock, the EPA must update its rules for approving new or expanded domestic drug-manufacturing capacity, and the EPA is designated as the lead coordinating agency for environmental permitting of such facilities, with a single point of contact assigned to each applicant. Also within 180 days, the Army Corps of Engineers must determine whether a dedicated nationwide permit is needed to speed up Clean Water Act approvals for pharmaceutical plant construction.
Pharmaceutical and drug-ingredient manufacturers — particularly those building, expanding, or retooling plants inside the United States — face a potentially faster and more predictable federal approval process for new facilities. Foreign drug manufacturers supplying the U.S. market face more frequent overseas inspections and higher fees to fund those inspections, as well as potential public disclosure if they fall out of compliance with FDA reporting requirements.