FDA Moves to Strengthen Drug Supply Chain with PreCheck Program

FDA announced on Aug. 7, 2025 a new program to increase regulatory predictability and facilitate construction of drug manufacturing facilities in the United States, with the purpose of strengthening the country’s domestic drug supply chain. FDA PreCheck was created in response to an executive order directing the agency to streamline review of domestic manufacturing plants and eliminate unnecessary regulatory requirements.

According to FDA, more than half of pharmaceuticals distributed in the US are made overseas, and the US is reliant on foreign API manufacturers, with only 11% of API manufacturers located domestically. The PreCheck Program will have a two-phase approach to the development of new manufacturing facilities in the US.

Streamlining the process

The Facility Readiness Phase will allow more frequent communication between manufacturers and FDA at critical stages, such as facility design, construction, and pre-production. Companies will be encouraged to provide the agency with comprehensive facility-specific information through a Type V drug master file (DMF) that should include site operating layout and description, quality system elements, and quality management maturity practices. The DMF can be used in a drug application as appropriate.

The Application Submission Phase will focus on streamlining development of the chemistry, manufacturing, and controls section of a drug application through pre-application meetings and feedback.

“Our gradual overreliance on foreign drug manufacturing has created national security risks,” said FDA Commissioner Marty Makary, MD, MPH, in a press release (1). “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.”

A public meeting, “Onshoring Manufacturing of Drugs and Biological Products", will be held on Sept. 30, 2025 that will feature a presentation of the FDA PreCheck program, stakeholder discussion, and additional considerations for overcoming onshoring challenges (2).

Pharma companies build in the US

Pharma companies may be responding to the current administration’s push to move drug manufacturing to the US, with some major names announcing new and/or expanded locations in the US. Eli Lilly and Company announced in February that it would be building four new domestic manufacturing sites in the US (3). In July, AstraZeneca announced it was investing $50 billion in US manufacturing and development, including a multi-billion-dollar facility in Virgina (4). Hikma Pharmaceuticals USA announced in June that it is investing $1 billion by 2030 to expand generic-drug manufacturing at its Ohio and New Jersey facilities (5). Also in June, BASF opened a good manufacturing practice (GMP) facility in Wyandotte, Mich., as part of the company’s commitment to providing a reliable supply of bioprocessing ingredients and excipients (6).

References

1. FDA. FDA Announces New FDA PreCheck Program to Boost US Drug Manufacturing. Press Release. Aug. 7, 2025. https://www.fda.gov/news-events/press-announcements/fda-announces-new-fda-precheck-program-boost-us-drug-manufacturing
2. FDA. Hearings, Meetings, Proceedings, etc.: Onshoring Manufacturing of Drugs and Biological Products. Federal Register. Aug. 8, 2025. https://www.federalregister.gov/public-inspection/2025-15083/hearings-meetings-proceedings-etc-onshoring-manufacturing-of-drugs-and-biological-products
3. Eli Lilly and Company. Lilly Plans to More Than Double US Manufacturing Investment Since 2020 Exceeding $50 Billion. Press Release. Feb. 26, 2025.
4. AstraZeneca. AstraZeneca Plans to Invest $50 Billion in America for Medicines Manufacturing and R&D. Press Release. July 21, 2025.
5. Hikma Pharmaceuticals. Hikma Pharmaceuticals USA Announces $1 Billion of New US Investment to Further Expand its Domestic Manufacturing and Development of Essential Generic Medicines. Press Release. June 28, 2025.
6. BASF. BASF Strengthens Its Commitment to the Biopharma and Pharmaceutical Ingredients Industries through a New Investment in North America. Press Release. June 17, 2025.