Eli Lilly, Regeneron among first selected for FDA initiative to speed facility reviews

• Selected facilities will primarily produce biologic drugs and genetic medicines, including Lilly's $2 billion Indiana site for GLP-1 ingredients and Regeneron's New York biologics facility
• The PreCheck program includes facility readiness technical guidance and expedited inspections, with Fujifilm expecting operational readiness review by year-end
• To qualify, companies must build facilities addressing market supply gaps or unmet medical needs, with only drugs relying on those specific facilities covered by the program

Summary: FDA Launches PreCheck Program to Expedite Manufacturing Facility Reviews

The FDA has selected seven companies for its new PreCheck pilot program, designed to accelerate regulatory reviews of domestic pharmaceutical manufacturing facilities by up to 14 months. The initiative allows regulators to review facilities during construction to identify and resolve issues earlier.

Selected Companies:

• Eli Lilly: $2 billion Lebanon, Indiana facility producing active ingredients for GLP-1 diabetes/weight-loss pills and injections
• Regeneron: Saratoga Springs, New York site for biologics and protein therapeutics across multiple diseases
• Fujifilm Biotechnologies: Holly Springs, North Carolina facility manufacturing monoclonal antibodies for Regeneron and other customers, with additional capacity opening in 2027-2028
• Amneal Pharmaceuticals: New York facility for sterile liquid products treating pain, respiratory, and ophthalmic diseases
• Cellares: New Jersey site producing cell-based gene therapies for oncology and hematology
• Kriya Therapeutics: North Carolina facility for AAV-based gene therapies for chronic diseases
• Kyowa Kirin: North Carolina biologics manufacturing for rare diseases

Program Structure:

The PreCheck program features two components: facility readiness (technical guidance pre-opening) and application submission (expedited inspections and feedback). Eligibility requires facilities addressing market supply gaps or unmet medical needs.

Market Implications:

This initiative aligns with the Trump administration's priority to boost domestic pharmaceutical production. The program primarily benefits biologics and gene therapy manufacturers, representing more complex production than traditional pills. The 14-month timeline reduction could significantly accelerate drug commercialization and enhance U.S. pharmaceutical self-sufficiency. Fujifilm expects operational readiness review completion by year-end, enabling faster FDA approval pathways for its customers.