FDA Picks 7 Drugmakers for PreCheck Pilot, Cutting U.S. Plant Reviews by Up to 14 Months
Updated
Updated · CNBC · Jun 29
FDA Picks 7 Drugmakers for PreCheck Pilot, Cutting U.S. Plant Reviews by Up to 14 Months
3 articles · Updated · CNBC · Jun 29
Summary
Seven companies — including Eli Lilly, Regeneron and Fujifilm Biotechnologies — were chosen for the FDA’s PreCheck pilot to speed reviews of new U.S. drug-manufacturing facilities.
Up to 14 months could be shaved from approvals because the FDA will review plants while they are still being built, offering technical guidance, hands-on application feedback and expedited inspections.
Lilly’s selected Indiana site will make ingredients for GLP-1 pills and shots, while Regeneron’s chosen $2 billion Saratoga Springs plant will produce biologics, sterile injectables and protein therapeutics.
Most of the first-round sites focus on biologics or gene therapies, and eligibility required a new facility tied to drugs that could fill supply gaps or improve access for unmet medical needs.
Domestic drug production has been a Trump administration priority, and Fujifilm said the program could bring an operational readiness review by year-end and help customers pursue faster approval pathways.
Will the FDA’s PreCheck program secure the US drug supply or just benefit a few pharmaceutical giants?
As automated factories get fast-tracked, how will regulators guarantee the safety of the medicines they produce?
Will accelerated domestic drug production lead to faster cures for patients or just higher medicine prices?
FDA PreCheck Pilot Program: Measuring Success in Boosting Domestic Drug Production and Supply Chain Resilience (2026)
Overview
In June 2026, the FDA launched the PreCheck Pilot Program and announced its first cohort of seven companies. This program aims to strengthen domestic drug manufacturing, enhance the resilience of the nation’s drug supply, and foster a more competitive U.S. pharmaceutical sector. To qualify, companies must establish new facilities focused on producing drugs that address supply gaps or unmet medical needs, with only drugs from these sites eligible for program benefits. By focusing on strategic investments in critical drug production areas, the PreCheck program is designed to ensure a more reliable and secure supply of essential medicines for the U.S.