Biopharma giants Eli Lilly and Regeneron and rapidly growing contract manufacturers Fujifilm and Cellares are among the seven companies selected by the FDA for its PreCheck Pilot Program, an initiative designed to strengthen drug manufacturing and bolster supply chain resilience in the United States.
Also tabbed for the program from a pool of more than 80 applicants are Amneal, Kyowa Kirin and Kriya Therapeutics. Each of the participants has a specific manufacturing facility under construction. The goal of the initiative is to reduce the complexities involved in setting up U.S. manufacturing plants.
The program is designed to encourage earlier FDA engagement and provide a more predictable regulatory pathway for companies that plan to manufacture drugs for the U.S. market and help support greater domestic access to critical medicines. The program could cut up to 14 months off review timelines, the FDA said.
Participating companies plan to manufacture drugs that address a market supply need or improve access to therapies for unmet needs. The companies also committed to submitting a New Drug Application (NDA), Biologics License Application (BLA), Abbreviated New Drug Application (ANDA) or a supplement to one of those applications that relies on the new manufacturing facility, the FDA said.
“The FDA's PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the United States, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines,” HHS Secretary Robert F. Kennedy, Jr. said in a release.
Three of the plants selected for the program are in North Carolina. They are Fujifilm’s commercial-scale cell culture biomanufacturing site in Holly Springs, Kriya’s AAV-based gene therapy production facility in Durham and Kyowa Kirin’s drug substance plant for rare diseases in Sanford.
Two sites are in New York—Regeneron’s drug substance and sterile injectables facility in Saratoga Springs and Amneal’s small molecule sterile liquid products plant in Long Island. Cellares’ cell-based gene therapy site is nearby in Bridgewater, N.J.
Lilly’s plant is on its huge active pharmaceutical ingredients (API) campus under construction in Lebanon, Indiana.
“Manufacturing and facility risks are usually the ones no one sees until a pre-approval inspection or a complete response letter, long after a sponsor has filed,” Eric Fulmer, SVP of Global Quality at Cellares, said in a release. “PreCheck moves that conversation up by several years, to a time before a facility is even in operation, which is taking it off the critical path. For the sponsors building and commercializing on Cellares’ platform, it means manufacturing is the one thing that won’t stand between their therapy and an approval.”
The FDA launched the program in February in response to President Donald Trump’s Executive Order, 14293, which he signed in May of last year to promote the domestic production of critical medicines.
In evaluating the requests of drugmakers, the FDA said it weighed the products to be manufactured, the stage of facility development, the anticipated timeline for bringing products to the U.S. market and the innovation in facility development and manufacturing operations.
There is a two-step process in the PreCheck program. Phase 1 is for facility readiness before a drug application is submitted. Phase 2 facilitates pre-submission meetings and enables inspections earlier in a review cycle, the FDA said.