“Back in the U.S.A.”: FDA Launches PreCheck Program to Boost Domestic Drug Manufacturing

Chuck Berry’s 1959 hit, “Back in the U.S.A.” came to mind as we reviewed the Food and Drug Administration’s recent move to bolster the resilience of the U.S. pharmaceutical supply chain by introducing the FDA PreCheck program. This initiative aims to enhance regulatory predictability, facilitate the establishment of drug manufacturing sites within the United States, and bring more drug manufacturing back to the U.S.

Background

• Currently, more than half of the pharmaceuticals distributed in the U.S. are manufactured overseas.
• The country also relies heavily on foreign sources for active pharmaceutical ingredients (“APIs”), with only 11% of API manufacturers based in the U.S.
• FDA Commissioner Marty Makary highlighted that this overreliance presents national security risks and emphasized the importance of reversing this trend to ensure a secure and domestic drug supply.

Highlights

• The FDA PreCheck program introduces a two-phase approach to streamline the development of new U.S. drug manufacturing facilities.
  1. Facility Readiness Phase
     This phase focuses on providing manufacturers with more frequent communication with FDA during critical development stages, including facility design, construction, and pre-production. Manufacturers are encouraged to submit a comprehensive facility-specific Type V Drug Master File, which includes site operations layout, Pharmaceutical Quality System elements, and Quality Management Maturity practices.^{1, 2}
  2. Application Submission Phase
     In this phase, the focus shifts to streamlining the development of the Chemistry, Manufacturing, and Controls section of drug applications. Pre-application meetings and early feedback help facilitate a more efficient review process.
• While FDA PreCheck is new in scope, it builds on earlier agency efforts to encourage early and collaborative engagement.
  1. The Emerging Technology Program – Designed to help industry adopt innovative manufacturing platforms with FDA input before full-scale implementation.
  2. Pre-ANDA and Pre-NDA Meetings – Allowing earlier discussion of application requirements to avoid surprises late in the product review cycle.
  3. Quality Metrics and Quality Management Maturity Initiatives – A push toward using performance data and evaluations of company quality practices as part of regulatory oversight.
• FDA PreCheck extends these principles to facility readiness itself, an area that, until now, has often been a late-stage hurdle in the approval process.
• FDA will host a public meeting, “Onshoring Manufacturing of Drugs and Biological Products” on September 30, 2025, to present the FDA PreCheck draft framework, hold stakeholder discussions on framework strengths and opportunities, and explore additional considerations to overcome current onshoring challenges relevant to FDA authority.

AGG Observations

• The FDA PreCheck program marks a shift from its historically reactive approach to facility inspections and application review.
• Traditionally, site inspections and compliance determinations occurred late in the application cycle, creating delays if facilities were unfinished or if deficiencies were identified.
• By introducing an early “Facility Readiness” phase, FDA indicates a willingness to decouple site qualification from individual drug application timelines. This shift could:
  1. Reduce Time-to-Market – Particularly for new entrants or companies relocating manufacturing to the U.S., early engagement with FDA may prevent costly rework and inspection delays.
  2. Increase Regulatory Predictability – More structured, proactive FDA feedback could help companies plan capital investments with greater certainty.
  3. Elevate Compliance Expectations – The emphasis on Quality Management Maturity may raise the bar for manufacturing oversight and documentation — creating both opportunities and compliance risks.
  4. Align With Broader Policy Trends – The program supports recent government initiatives aimed at reducing supply chain vulnerabilities in essential medicines and APIs — a priority reinforced by pandemic-era shortages.
• Companies evaluating onshoring or expansion projects should assess whether current or planned facilities could qualify for early participation and factor this into regulatory, operational, and supply chain strategies.

By streamlining regulatory processes and fostering early engagement, the initiative aims to reduce dependence on foreign drug production and enhance the resilience of the domestic drug supply. In a nod to Chuck Berry, the program reflects a broader strategic focus on expanding domestic manufacturing capacity and encouraging companies to align early with FDA guidance — ultimately strengthening the drug supply “back in the U.S.A.”

[1] FDA defines a Pharmaceutical Quality System (PQS), consistent with ICH Q10, as including “process performance and product quality monitoring, corrective action and preventive action (CAPA), change management, and management review” — the core systems manufacturers must implement to ensure product quality throughout the lifecycle. See FDA Guidance for Industry, Q10 Pharmaceutical Quality System (Apr. 2009).

[2] FDA defines Quality Management Maturity (QMM) as “the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.” See FDA, Quality Management Maturity Program: Practice Areas and Prototype Assessment Protocol (Draft, Nov. 2023).