Seven companies including Eli Lilly and Regeneron were picked for an FDA pilot that could cut up to 14 months off new drug-plant approvals. The PreCheck program lets regulators review facilities while they're still under construction.
The FDA selected Eli Lilly and Regeneron among seven companies for a pilot program that lets regulators review new manufacturing facilities while they are still under construction, the agency said. The PreCheck initiative could cut up to 14 months off the typical timeline for approving a new drug plant, according to FDA spokesperson Benjamin Nichols.
Lilly's Lebanon, Indiana, facility – the site that will produce the active ingredients for its GLP-1 pills and shots – was chosen. The company said it is "evaluating how PreCheck and related regulatory improvements may impact the facility's timeline." Regeneron's $2 billion Saratoga Springs, New York, site, announced last fall, also made the cut. CEO Leonard Schleifer said Regeneron has pushed for more domestic medicine production and welcomed the program.
The other five participants are Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin. Most plan to make biologic drugs or gene therapies, which involve more complex manufacturing than standard pills. To qualify, a company had to build a facility that would fill a market supply gap or improve access to therapies for unmet medical needs.
Fujifilm's Holly Springs, North Carolina, site – already making monoclonal antibodies for Regeneron and Johnson & Johnson – was selected. The contract manufacturer expects the operational readiness review before year-end under the expedited process, and said the program should let its customers pursue faster approval pathways with the FDA.
The PreCheck program has two parts: facility readiness, where the FDA provides technical guidance before the site opens, and application submission, where participants get hands-on feedback and expedited inspections. Producing more drugs domestically has been a priority for the Trump administration.
Lilly carries an Alpha Score of 73 out of 100, labeled Moderate, in the Healthcare sector. Johnson & Johnson scores 63, also Moderate.
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