Regulatory Relief To Promote Domestic Production of Critical Medicines
This Executive Order directs federal agencies to speed up and simplify regulatory reviews and permitting to encourage more pharmaceutical manufacturing in the United States. It requires the Food and Drug Administration (FDA), Environmental Protection Agency (EPA), and the U.S. Army Corps of Engineers to review and revise rules, guidance, and permitting processes on tight timelines (90–180 days) to reduce duplication, increase predictability, and accelerate construction, expansion, or repurposing of facilities that make medicines and their inputs. The order also calls for increased and publicly reported inspections of foreign drug manufacturing facilities and allows fee increases on overseas facilities consistent with law. The purpose is to restore and expand domestic pharmaceutical production capacity for public-health and national-security reasons by removing regulatory barriers that investors and manufacturers say lengthen project timelines. Because this is an executive order, it directs agency action but does not by itself change statutes or appropriate funds; agencies must act consistent with existing law and available appropriations.
Key Points
- 1FDA review and reform (180 days): The FDA Commissioner must review regulations and guidance affecting development, inspection, and approval of new or expanded U.S. pharmaceutical manufacturing (including active pharmaceutical ingredients and raw materials), eliminate duplicative requirements, improve timeliness and predictability of reviews, and update compliance policies as appropriate.
- 2FDA inspection and guidance actions: The order directs the FDA to reevaluate its risk-based approach to pre-licensure inspections (when inspections are required and how they are conducted), expand programs that give early technical advice to facilities, strengthen enforcement of reporting under 21 U.S.C. 360(j)(3) (including considering public disclosure of noncompliant facilities), and give clearer guidance on site changes and validation when moving production domestically.
- 3Foreign facility inspections and transparency (90 days): The FDA must improve its risk-based regime for inspecting foreign manufacturing sites supplying U.S. medicines, fund this to the extent allowed by law through higher fees on foreign facilities, and publicly disclose annual inspection counts by country and manufacturer.
- 4EPA permitting and NEPA coordination (180 days): The EPA must update its regulations and guidance to remove unnecessary or duplicative requirements and make review more predictable and timely. For projects needing an Environmental Impact Statement (EIS) under NEPA, the EPA is designated the lead agency (unless another agency takes that role) and must provide a single agency point of contact; OMB and coordinating bodies are to help expedite permit reviews.
- 5Army Corps permit review (180 days): The Department of the Army/Army Corps must review nationwide permits under the Clean Water Act and Rivers and Harbors Act to see whether an activity-specific nationwide permit (a streamlined permit for specified activities) is needed to facilitate pharmaceutical manufacturing permitting.