- Eli Lilly and Regeneron have been selected for the FDA's PreCheck program, which aims to accelerate reviews of new domestic pharmaceutical manufacturing facilities.
- The FDA has chosen Eli Lilly's Lebanon, Indiana facility and Regeneron's Saratoga Springs, New York site for this initiative.
- The PreCheck program allows regulators to start reviewing manufacturing facilities while they are being built, which could save companies up to 14 months.
- This initiative is part of a broader goal to strengthen the U.S. pharmaceutical supply chain and reduce dependence on overseas manufacturing.
- The FDA PreCheck program is designed to modernize how the agency oversees the construction and readiness of pharmaceutical production sites by engaging with companies earlier in the process.
- Participating companies can collaborate with the FDA during the design and construction phases, improving compliance planning and making final approvals more efficient.
- Regeneron CEO Leonard Schleifer emphasized the company's commitment to U.S. biologics manufacturing and the importance of domestic production of medicines.
Eli Lilly and Regeneron have been chosen for the FDA's new PreCheck program, which aims to expedite the review of new pharmaceutical manufacturing facilities. This initiative allows regulators to begin assessments while facilities are still under construction, potentially saving companies up to 14 months in approval time.137
The FDA's selection of Lilly's Lebanon, Indiana facility and Regeneron's Saratoga Springs, New York site reflects their significant investments in expanding U.S.-based production capacity. The program is designed to modernize regulatory oversight by engaging with companies earlier in the construction process, thereby improving compliance and efficiency.2
The initiative's broader goal is to strengthen the U.S. pharmaceutical supply chain by reducing dependence on overseas manufacturing and improving access to critical medicines. As stated by Regeneron CEO Leonard Schleifer, the company has invested in U.S. biologics manufacturing and supports increased domestic production of medicines.4
The FDA's PreCheck program is part of a growing policy emphasis on reshoring key parts of the healthcare and biotech supply chain. By facilitating faster and more predictable construction of domestic drug production sites, the FDA aims to enhance the resilience of the pharmaceutical supply chain.
Eli Lilly noted that it is evaluating how the PreCheck program may impact its facility's timeline and will work closely with the FDA to support the program's success. The initiative is expected to reshape how quickly companies can bring complex therapies to market, with investors closely monitoring the implications for U.S. biopharmaceutical manufacturing stocks.
“The FDA has selected Eli Lilly and Regeneron for its PreCheck program, which aims to speed up the review of new pharmaceutical manufacturing facilities. This initiative is part of a broader strategy to enhance domestic drug production and reduce reliance on overseas manufacturing.”
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