FDA’s PreCheck Pilot Program Accelerates Domestic Drug Facility Reviews

On June 29, 2026, the FDA announced Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin in PreCheck, which lets regulators review facilities during construction and could cut review time by up to 14 months.

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The program follows a 2025 executive order by President Donald Trump directing the FDA to expand U.S. drug manufacturing. It addresses a supply chain where overseas active pharmaceutical ingredients (APIs) supply about 89 % of U.S. demand and aligns with deals to lower Medicaid prices for tariff exemptions.

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

Lilly’s Lebanon, Indiana, plant will produce weight-loss drug ingredients. Regeneron’s Saratoga Springs, New York, site will make biotechnology drug substance, sterile injectables and protein therapeutics. The other firms will build oncology, hematology, chronic and rare-disease facilities in North Carolina, New Jersey and New York.

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

Seven firms join the pilot. The FDA projects up to a 14-month reduction in review time per site. API output is 11 % of U.S. supply, while over half of U.S. drugs are produced abroad. The program targets facilities that fill supply gaps or meet unmet medical needs.

A new FDA strategy aims to get medicines to the market faster

Accelerating facility readiness aims to raise production capacity, create high-skill jobs and improve resilience to supply shocks. Faster approvals could also shorten market entry for new biologics and gene therapies, expanding patient access to treatments.

A new FDA strategy aims to get medicines to the market faster

FDA spokesperson Benjamin Nichols outlined a two-phase process: a Facility Readiness phase with design and construction communication, and an Application Submission phase that gives feedback on chemistry, manufacturing and controls. Only drugs made at participating sites will use accelerated pathway. US health secretary Robert F. Kennedy Jr. stressed strategic need to rebuild the pharmaceutical base for national health and security.

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

• “Kennedy (RFK) Jr commented: “President Trump is rebuilding America’s pharmaceutical manufacturing base because our nation’s health and security depend on it.” — Robert F. Kennedy Jr., U.S. Health Secretary

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

• “The FDA’s PreCheck Pilot Program will help bring pharmaceutical manufacturing back to the US, strengthen our drug supply chains, create high-quality American jobs, and ensure patients have reliable access to safe, effective medicines.” — FDA statement

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

• “The program will allow regulators to start reviewing new manufacturing facilities while they are being built to catch and correct any issues, which the FDA estimates could save companies up to 14 months, the report said.” — FDA

Reuters

• “The first stage, called the Facility Readiness phase, will allow more frequent communication with the FDA to discuss facility design, construction, and pre-production.” — FDA

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

The PreCheck pilot began in February 2026 and will run through construction and pre-production of the selected sites. The FDA will assess results before expanding the scheme to more manufacturers. Companies must submit facility designs and quality-control plans for review, with the first accelerated approvals targeted for late 2027.

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme