Eli Lilly, Regeneron join FDA pilot to speed U.S. drug plant reviews

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FDA drug plant review pilot

Highlights

Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin are the first participants in the FDA's PreCheck pilot program targeting new U.S. drug manufacturing sites.
Lilly's Lebanon, Indiana facility will produce GLP-1 drug ingredients and is assessing how PreCheck and potential regulatory changes may affect its operational timeline.
Regeneron's $2 billion Saratoga Springs, New York facility and Fujifilm's Holly Springs, North Carolina site are positioned for expedited FDA review, with readiness evaluations expected before year-end and further expansions planned through 2028.

Initial selections and program scope

As first reported by CNBC, Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics and Kyowa Kirin are the first seven companies chosen for the FDA's PreCheck pilot program, according to FDA spokesperson Benjamin Nichols. The program is designed for new manufacturing facilities that can help address supply gaps or expand access to treatments for unmet medical needs, and only drugs that depend on those sites are covered.

The initiative includes two parts, facility readiness and application submission. Under those tracks, the FDA provides technical guidance before a site opens, along with more direct feedback, expedited inspections and faster facility evaluation.

Domestic drug production remains a policy priority for the Trump administration. Most of the selected companies are preparing to manufacture biologic drugs or genetic medicines, which generally require more complex production processes than traditional pills.

Facility pipeline and industry impact

The selected projects span both large pharmaceutical groups and smaller biotechnology companies. Lilly's chosen facility in Lebanon, Indiana, is set to produce the main ingredients for GLP-1 pills and injections, and the company says it is evaluating how PreCheck and related regulatory changes may affect the site's timeline while continuing to work with the FDA.

Regeneron's selected project is its $2 billion site in Saratoga Springs, New York, announced last fall. In a statement, Chief Executive Leonard Schleifer says the company has invested in U.S. biologics manufacturing and supports greater emphasis on domestic medicine production.

Fujifilm Biotechnologies is also included with its Holly Springs, North Carolina, facility, which opened last year and is already producing monoclonal antibodies for Regeneron and Johnson & Johnson. The company says it expects an operational readiness review before the end of the year through the faster process, while more parts of the site are due to open in 2027 and 2028, potentially giving customers a quicker path to FDA approvals.

Our earlier report on Johnson & Johnson’s $55 billion U.S. expansion explained how the company is aligning its manufacturing strategy with a policy environment aimed at strengthening domestic production. We noted CEO Joaquin Duato’s comments that J&J plans to produce its medicines and medical technology products in the United States, underscoring a broader push to onshore critical healthcare manufacturing.

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