FDA Taps Lilly, Regeneron and Five Others for Fast-Track Drug Manufacturing Pilot

The U.S. Food and Drug Administration on June 30 officially announced it has selected seven companies for its PreCheck pilot program, an initiative aimed at accelerating regulatory reviews of new drug manufacturing facilities to bolster domestic pharmaceutical production and supply-chain resilience. The chosen companies include Eli Lilly, Regeneron, Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin.^[FDA] As of 12:30 p.m. ET on June 30, Eli Lilly (LLY) shares were trading at $1,201.22, down 2.33% from the prior close of $1,229.93; Regeneron (REGN) share price was not immediately reflected in real-time quotes.

Lilly and Regeneron Lead the Seven Selected

The FDA said it received more than 80 requests to participate in the PreCheck pilot during the application window from February 1 to March 1, 2026.^[FDA] After evaluation, it selected facilities from seven companies, all located in the U.S. and planning to produce drugs that meet market demand or improve patient access to therapies.

According to the FDA and multiple media reports, Lilly’s participating facility is an active pharmaceutical ingredient (API) plant at its Lebanon, Indiana, campus, which will be used to produce “existing and future medicines.” Lilly recently announced an additional $4.5 billion investment on top of the $27 billion already committed to the site.^{[Pharmaphorum]} Regeneron’s facility in Saratoga Springs, New York, will produce biologics, sterile injectables, and novel protein therapeutics.^[CNBC]

The other selected companies and their facilities include: Amneal’s plant in Long Island, New York (small-molecule sterile liquid products); Cellares’ facility in Bridgewater, New Jersey (cell and gene therapies); Fujifilm Biotechnologies’ cell-culture biomanufacturing plant in Holly Springs, North Carolina; Kriya Therapeutics’ site in Durham, North Carolina (AAV gene therapies); and Kyowa Kirin’s facility in Sanford, North Carolina (biologics).^[FDA]

PreCheck Pilot: Faster Approvals, Stronger Supply Chain

The FDA formally launched the PreCheck pilot on February 1, 2026, in response to President Trump’s Executive Order 14293, signed in May 2025.^[FDA] The program uses a two-phase approach to speed up approvals for new manufacturing facilities. Phase one aims to provide faster agency responses for plant design, construction, and pre-production startup tasks; phase two accelerates the review of chemistry, manufacturing, and controls (CMC) sections in new facility applications through enhanced FDA interaction.^{[Pharmaphorum]}

The FDA stated the program is designed to “boost U.S. global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain.”^[FDA] Health and Human Services Secretary Robert F. Kennedy Jr. said in a statement: “President Trump is rebuilding America’s pharmaceutical manufacturing base because our nation’s health and safety depend on it. The FDA’s PreCheck pilot program will help bring drug manufacturing back to the United States, strengthen our drug supply chain, create high-quality American jobs, and ensure patients have reliable access to safe and effective medicines.”^[FDA]

Company Responses: Strategic Milestones and Long-Term Plans

Several selected companies welcomed the news, emphasizing the program’s importance to their long-term strategies. Dr. Shankar Ramaswamy, CEO and co-founder of Kriya Therapeutics, said: “Being selected for the FDA PreCheck pilot program is a significant validation of our investment in manufacturing as a core internal strategic capability. From the beginning, our vision has been to develop transformative durable medicines for chronic diseases affecting millions of Americans, along with the integrated infrastructure needed to manufacture them efficiently, consistently, and at scale.”^[BioSpace]

Toshiyuki Kurata, Chief Supply Chain Officer at Kyowa Kirin, added: “Being selected for the FDA PreCheck pilot program is a transformative milestone for Kyowa Kirin as a global organization. The Sanford facility is our first manufacturing site in the United States, and through this program, we have the opportunity to build our quality and compliance framework from the ground up in close collaboration with the FDA — setting a new standard for how we manufacture.”^{[The Manila Times]}

Market Reaction and Context

While the news is a long-term positive for the selected companies, Eli Lilly (LLY) shares were trading at $1,201.22 as of 12:30 p.m. ET on June 30, down 2.33% from the prior close of $1,229.93, with an intraday low of $1,190.2.^[CNBC] Market analysts noted the price movement could be driven by broader market trends, sector sentiment, or other company-specific fundamentals, rather than a direct reaction to the PreCheck program itself.

The launch of the PreCheck pilot comes as the U.S. government pushes aggressively to reshore pharmaceutical manufacturing. Through tariff threats and executive orders, the Trump administration has prompted several large drugmakers to commit tens of billions of dollars in U.S. investments to avoid tariffs on imported drugs.^{[Pharmaphorum]} FDA Acting Commissioner Kyle Diamantas emphasized in a statement: “This milestone reflects the Trump administration’s commitment to strengthening domestic drug manufacturing capacity, creating American jobs, and lowering drug costs for families. It further highlights the value of early FDA engagement in building a more resilient U.S. drug supply chain and reducing reliance on foreign sources of drug production.”^[FDA]

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