Back in the U.S.A
“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.
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.
The FDA PreCheck program introduces a two-phase approach to streamline the development of new U.S. drug manufacturing facilities. 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.
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. The Emerging Technology Program – Designed to help industry adopt innovative manufacturing platforms with FDA input before full-scale implementation.
Pre-ANDA and Pre-NDA Meetings – Allowing earlier discussion of application requirements to avoid surprises late in the product review cycle. 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.
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.
