The Food and Drug Administration has introduced FDA PreCheck, an initiative designed to improve regulatory predictability and support the construction of pharmaceutical facilities within the United States.
Reliance on overseas facilities
More than half of the medicines distributed in the United States are manufactured abroad. For active pharmaceutical ingredients (APIs), only 11% of the manufacturers supplying FDA-approved products are based in the U.S.
Commissioner Marty Makary’s statement
“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said Marty Makary, M.D., M.P.H., FDA Commissioner. “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.”
Origins of the initiative
The program was created in response to Executive Order 14293, “Regulatory Relief to Promote Domestic Production of Critical Medicines.” This order directs the FDA to streamline the review process for domestic pharmaceutical manufacturing, remove unnecessary regulatory requirements, and improve approval timelines and predictability.
Two-phase approach to speed up production
The PreCheck model is structured in two phases:
- Facility Readiness Phase: provides more frequent communication with the FDA at critical stages, from design and construction to pre-production. It allows manufacturers to submit a Type V Drug Master File with detailed information on the facility, quality systems, and management practices. This DMF can be referenced in drug approval applications.
- Application Submission Phase: focuses on expediting the development of the Chemistry, Manufacturing, and Controls section of applications through pre-application meetings and early feedback.
Public meeting in September
The FDA will hold a public meeting on September 30, 2025, from 9:00 AM to 4:00 PM, at the White Oak Campus in Silver Spring, Maryland, with virtual participation available. The event will include the presentation of the draft PreCheck framework, stakeholder discussions, and analysis of the challenges involved in bringing pharmaceutical production back to U.S. soil.
more info: https://to5.me/s/a79 or contact PublicEngagement@fda.hhs.gov
Glossary
- API: Active pharmaceutical ingredient, the key component of a medicine.
- DMF (Drug Master File): Technical document containing confidential information on manufacturing processes, facilities, and quality controls, used in support of an authorization application.
- Executive Order: Presidential directive that is binding on federal agencies.
- FDA: Food and Drug Administration, the U.S. federal agency responsible for regulating food, medicines, medical devices, and other products.
- PreCheck: FDA program designed to streamline the approval process for pharmaceutical manufacturing facilities in the U.S.
