Regulatory Relief To Promote Domestic Production of Critical Medicines

This Executive Order aims to strengthen the U.S. pharmaceutical supply chain by removing regulatory barriers to domestic manufacturing. It directs the FDA, EPA, and U.S. Army Corps of Engineers to review and streamline applicable regulations and guidance within 180 days to improve the timeliness and predictability of agency review processes. The order also calls for enhanced inspections of foreign pharmaceutical facilities, increased transparency on inspection activities, and centralized coordination of environmental permits for new manufacturing sites. The policy goal is to create a more resilient, competitive, and secure domestic pharmaceutical manufacturing base.

• HHS
• FDA
• EPA
• U.S. Army Corps of Engineers

90 days; 180 days.

Review and revise existing FDA regulations and guidance related to domestic pharmaceutical manufacturing, including inspections, approvals, and emerging technologies. - 180 days. Improve risk-based inspection regime for overseas manufacturing facilities; increase transparency on inspection frequency by country/manufacturer. - 90 days. Update EPA regulations and guidance for approving new/expanded domestic pharmaceutical manufacturing capacity to eliminate duplicative/unnecessary requirements. - 180 days. EPA as lead agency under NEPA for pharmaceutical manufacturing facilities requiring Environmental Impact Statements; designate a single point of contact for applicants. – Immediate. Review and determine whether new nationwide permits are needed to facilitate pharmaceutical manufacturing under Clean Water Act and Rivers and Harbors Act. - 180 days

Onshoring Pharma Ops: Reading Recent EO and Policy Tea Leaves

No known legal challenges.