Eli Lilly, Regeneron among first companies selected for FDA initiative to speed review of new manufacturing facilities

The U.S. Food and Drug Administration has selected seven pharmaceutical companies, including Eli Lilly and Regeneron, to participate in its new PreCheck pilot program aimed at accelerating the review of domestic manufacturing facilities. By allowing regulators to evaluate sites during construction, the initiative seeks to identify and resolve potential issues early, potentially shortening the timeline for operational readiness by up to 14 months. This program is particularly significant for the pharmaceutical sector as it prioritizes domestic production of complex biologics and genetic medicines to address supply gaps and unmet medical needs.

The FDA's PreCheck pilot program includes a diverse group of participants ranging from global leaders like Eli Lilly to specialized firms such as Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin. The initiative focuses on facilities producing biologics and genetic medicines, which require more intricate manufacturing processes than traditional drugs. To qualify, companies must be building new domestic sites capable of addressing market supply shortages or improving access to therapies for critical unmet needs. The program is divided into two phases: technical guidance during facility readiness and hands-on feedback during the application submission phase, which includes expedited inspections and facility evaluations.

Specific projects selected for the program include Eli Lilly’s facility in Lebanon, Indiana, which is dedicated to producing active ingredients for GLP-1 weight-loss and diabetes treatments. Regeneron’s $2 billion site in Saratoga Springs, New York, also secured a spot in the pilot, with CEO Leonard Schleifer emphasizing that such collaboration between innovators and regulators strengthens the American biopharmaceutical industry. Additionally, Fujifilm Biotechnologies’ Holly Springs, North Carolina, site is participating; this contract manufacturing facility already produces monoclonal antibodies for major clients like Johnson & Johnson and Regeneron, with further expansion planned through 2028.

The potential impact of the PreCheck program on the pharmaceutical industry is substantial, as the FDA estimates it could save companies up to 14 months in regulatory lead time. Fujifilm Biotechnologies has already indicated it expects an operational readiness review by the end of the year, potentially allowing its customers to pursue faster drug approval pathways. By streamlining the oversight of complex manufacturing infrastructure, the FDA aims to bolster the domestic supply chain and ensure that innovative therapies reach the market more efficiently, aligning with broader federal priorities to increase U.S.-based drug production.