WASHINGTON, D.C. — The U.S. Food and Drug Administration has unveiled FDA PreCheck, a new initiative designed to strengthen the domestic pharmaceutical supply chain by making the process of building and certifying drug manufacturing facilities in the United States more predictable and efficient.
The move comes amid concerns over America’s heavy reliance on foreign drug production. More than half of pharmaceuticals distributed in the U.S. are manufactured overseas, and only 11% of manufacturers producing active pharmaceutical ingredients (APIs) for FDA-approved drugs are based domestically.
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, M.D., M.P.H. “The FDA PreCheck initiative is one of many steps FDA is taking that can help reverse America’s reliance on foreign drug manufacturing and ensure that Americans have a resilient, strong, and domestic drug supply.”
Two-Phase Approach to Onshoring
Developed in response to Executive Order 14293, Regulatory Relief to Promote Domestic Production of Critical Medicines, FDA PreCheck seeks to streamline regulatory reviews for U.S.-based pharmaceutical manufacturing while removing unnecessary requirements.
The program features a two-phase framework:
- Facility Readiness Phase: Manufacturers will have increased access to FDA guidance at key development stages, from facility design to pre-production. Companies are encouraged to provide detailed, facility-specific information—such as operational layouts, quality management practices, and Pharmaceutical Quality System details—through a Type V Drug Master File (DMF). This DMF can later be referenced in drug applications to expedite approvals.
- Application Submission Phase: This phase focuses on streamlining the Chemistry, Manufacturing, and Controls (CMC) section of applications through pre-application meetings and early FDA feedback, reducing delays in the review process.
Public Input Planned
To advance the program, the FDA will host a public meeting, Onshoring Manufacturing of Drugs and Biological Products, on September 30, 2025, at its White Oak Campus in Silver Spring, Maryland, with a virtual participation option. The session will present the draft PreCheck framework, gather stakeholder feedback, and explore additional strategies to overcome onshoring challenges within the agency’s authority.
The initiative is part of a broader federal effort to reduce dependency on overseas drug production, increase supply chain resilience, and safeguard access to critical medicines in the face of global disruptions.
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