Drugmakers picked for FDA pilot to speed factory reviews
The FDA program lets regulators review some drug plants before they open, a process the agency says could cut months from approvals.
By Sofia Marchetti · World Affairs Correspondent
3 min read
The Food and Drug Administration has selected seven companies for an early pilot program meant to speed reviews of new pharmaceutical manufacturing sites in the U.S. CNBC reported that Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first participants.
The program, called FDA PreCheck, allows regulators to examine manufacturing facilities while they are still being built, according to FDA spokesperson Benjamin Nichols, as reported by CNBC. The agency estimates that earlier checks could help companies identify and fix problems sooner and save as much as 14 months.
CNBC reported that the effort fits with the Trump administration’s push for more medicine production inside the United States. The first group includes large drugmakers, contract manufacturers and biotechnology companies, with most of the selected sites tied to biologic drugs or genetic medicines, products that CNBC reported can be more complex to manufacture than standard pills.
To qualify, companies had to be building a new manufacturing facility that could help close a market supply gap or improve access to treatments for unmet medical needs, CNBC reported. Only drugs dependent on the selected site will be covered by the pilot program.
Lilly’s selected site is in Lebanon, Indiana, according to CNBC. The facility will make the main ingredients for GLP-1 pills and injections. Lilly told CNBC it is assessing how PreCheck and related regulatory changes could affect the site’s timeline and said it would keep working with the FDA on the program.
Regeneron’s chosen project is its $2 billion site in Saratoga Springs, New York, CNBC reported. The company announced that facility last fall. Regeneron CEO Leonard Schleifer said in a statement to CNBC that the company has invested in U.S. biologics manufacturing and has supported more attention to domestic medicine production.
Fujifilm Biotechnologies’ new facility in Holly Springs, North Carolina, was also selected, according to CNBC. The contract manufacturer opened the site last year and is already making monoclonal antibodies for Regeneron and Johnson & Johnson, with more production planned as additional parts of the facility open in 2027 and 2028.
CNBC reported that FDA PreCheck has two parts. Under facility readiness, the FDA gives technical guidance before a site opens. Under application submission, companies can receive more direct feedback from the agency, along with faster inspections and facility evaluations.
Fujifilm told CNBC it expects an operational readiness review before the end of the year because of the faster process. The company also said the program could let its customers seek quicker FDA approval paths.
The initial FDA PreCheck participants and selected facilities are:
- Amneal Pharmaceuticals: a New York site for small molecule sterile liquid products used in pain management, respiratory disease and ophthalmic disease.
- Cellares: a New Jersey site for cell-based gene therapies for oncology and hematology diseases.
- Eli Lilly: an Indiana site for main ingredients used in GLP-1 pills and shots.
- Fujifilm Biotechnologies: a North Carolina site for monoclonal antibodies.
- Kriya Therapeutics: a North Carolina site for AAV-based gene therapies for chronic diseases.
- Kyowa Kirin: a North Carolina site for biologics for rare diseases.
- Regeneron: a New York site for biologic drug substance, sterile injectables and protein therapeutics for multiple diseases.
This story draws on original reporting from CNBC.