White House Issues Executive Order to Accelerate Domestic Pharmaceutical Manufacturing

On May 5, the White House released an executive order directing a broad regulatory overhaul aimed at expediting the construction and expansion of pharmaceutical manufacturing facilities within the United States. The action is framed as part of a national strategy to strengthen domestic drug supply chains and reduce dependence on foreign producers. 

The order mandates the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and Army Corps of Engineers to streamline their respective permitting and inspection processes. Within 180 days, each agency must review and revise existing guidance, eliminate duplicative or outdated requirements, and improve coordination to reduce delays in approving new or expanded pharmaceutical production facilities. 

Among the key directives: 

• FDA is tasked with reforming its review of licensure inspections, enhancing early technical engagement with industry, publishing compliance data for foreign facilities, and clarifying policies on shifting production from international to domestic sites. 

• EPA is ordered to update environmental permitting guidance and act as the lead agency for permitting pharmaceutical facilities under the National Environmental Policy Act (NEPA). 

• Army Corps of Engineers is directed to assess whether new, activity-specific nationwide permits are needed to facilitate Clean Water Act approvals for pharmaceutical manufacturing projects. 

The order also calls for improved oversight of overseas facilities supplying the U.S. market, including publishing country- and manufacturer-specific inspection data and funding enhanced inspections through higher foreign facility fees. 

This directive builds on a 2020 executive order (EO 13944) and marks a significant escalation in the administration’s push to re-shore essential medicine production. It is expected to initiate a series of regulatory actions that may reshape both facility design and the project approval landscape for pharmaceutical engineering in the U.S. 

Read the full order at: https://www.whitehouse.gov/presidential-actions/2025/05/regulatory-relief-to-promote-domestic-production-of-critical-medicines/