On May 5, 2025, President Trump signed the Executive Order “Regulatory Relief to Promote Domestic Production of Critical Medicines.” The Executive Order and its fact sheet underscore the regulatory barriers that hinder the establishment and expansion of pharmaceutical manufacturing in the United States.
A key challenge is the protracted timeline – often five to 10 years – required to build new manufacturing facilities due to myriad federal, state, and local requirements such as building standards, zoning restrictions, and environmental protocols. The Executive Order deems such delays “unacceptable from a national security standpoint.” It also highlights that even expanding or modifying existing facilities can trigger complex permitting and regulatory approval.
To address these barriers, the Executive Order directs the Food and Drug Administration (FDA) to accelerate approval timelines for domestic manufacturing sites by:
- Eliminating duplicative requirements.
- Streamlining reviews.
- Enhancing early-stage technical assistance to manufacturers.
- Improving data reporting under Section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act (FDCA), potentially including public disclosure of noncompliant facilities.
- Issuing guidance on site changes.
The Environmental Protection Agency (EPA) is similarly tasked with updating regulations and guidance to expedite the inspection and permitting of new or expanded pharmaceutical facilities.
FDA Expands Use of Unannounced Inspections at Foreign Manufacturing Sites
The Executive Order also addresses perceived disparities in inspection practices. It points out that the FDA’s unannounced inspections of U.S. manufacturers contrast with advance notice often given to foreign facilities. On May 6, 2025, the day after the Executive Order was released, the FDA announced the expansion of unannounced inspections at foreign facilities. Commissioner Martin A. Makary stated:
For too long, foreign companies have enjoyed a double standard – given advanced notice before facility inspections, while American manufacturers are held to rigorous standards with no such warning. That ends today. This is a key step for the FDA as part of a broader strategy to get foreign inspections back on track.
The FDA notes that it aims to identify violations by expanding unannounced inspections. It will also clarify policies for FDA investigators to refuse travel accommodations from regulated industry, further strengthening the integrity of the inspection process.
Voluntary Participation in the FDA’s 2025 QMM Prototype Assessment Program
While the Executive Order encourages the FDA to increase oversight of foreign drug manufacturers, the agency is simultaneously working to reward those manufacturers that demonstrate mature quality systems. As a next step, the FDA’s Center for Drug Evaluation and Research (CDER) is continuing its voluntary Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program in 2025. The QMM program encourages drug manufacturers to adopt advanced quality management practices that go beyond CGMP compliance.
From 2020 to 2024, the CDER conducted several pilot programs assessing QMM at both domestic and foreign manufacturing facilities. Building on these efforts, the 2025 program will use a prototype protocol to assess establishments across five practice areas:
- Management commitment to quality.
- Business continuity.
- Technical excellence.
- Advanced pharmaceutical quality systems.
- Employee empowerment and engagement.
In order to be eligible to participate in the program, establishments must:
- Be registered with the FDA under Section 510 of the FDCA and meet the definition of “establishment” under 21 C.F.R. 207.1.
- Manufacture drugs or active pharmaceutical ingredients (APIs) subject to FDA approval or licensure or marketed under Section 505G (OTC monograph drugs).
- Have undergone at least one human drug surveillance inspection.
- Currently hold an inspection classification of “No Action Indicated” or “Voluntary Action Indicated.”
- Be willing to undergo an onsite or hybrid assessment.
Interested parties should submit a request to participate by June 9, 2025.
Inspection Readiness: Key Considerations for Drug Manufacturers
In light of the FDA’s expanding use of unannounced inspections, both domestic and foreign drug manufacturing facilities must be inspection-ready at all times. Inspection readiness goes beyond passing an inspection – it reflects a continuous commitment to product quality and patient safety.
Before the FDA sends its investigators to a manufacturing facility, it typically reviews a facility’s most recent establishment inspection reports (EIRs), responses to Form FDA 483s, and any associated warning letters. Facilities must be able to demonstrate that they have addressed any previously identified observations or concerns. We suggest the following to prepare for an FDA inspection:
- Maintain open communication with the FDA and understand regulatory expectations.
- Conduct regular reviews of systems, procedures, and documentation.
- Assess performance to identify areas for improvement.
- Establish a dedicated inspection team with clearly assigned roles and responsibilities.
If you have questions about inspection preparedness, compliance strategies, or enforcement risks – or would like assistance evaluating your current inspection readiness – please contact our team.
Executive Order, Action & Proclamation Task Force
Alston & Bird's multidisciplinary Executive Order, Action & Proclamation Task Force advises clients on the business and legal implications of President Trump's Executive Orders.
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If you have any questions, or would like additional information, please contact one of the attorneys on our FDA: Compliance & Enforcement team or one of the attorneys on our FDA: Drug & Device team.
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