Streamlining Drug Manufacturing
FDA PreCheck Program Expedites Reviews for New Drug Facilities, Cutting Market Timelines
Anonymous
Key Points
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Eli Lilly has earmarked about $27 billion to build four new pharmaceutical manufacturing facilities in the United States, signaling a large-scale expansion beyond the Lebanon, Indiana site highlighted in PreCheck.
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Regeneron’s PreCheck participation includes its $2 billion manufacturing site in Saratoga Springs, New York, announced last fall and selected for the pilot.
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The Lilly Lebanon, Indiana facility at the center of the program will produce the main ingredients for GLP-1 pills and injections, illustrating the scale and focus of PreCheck’s intended drug classes.
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Under PreCheck, the FDA will cover only drugs that rely on the new facilities for their manufacture, meaning products not dependent on these sites are not included in the pilot.
The FDA has launched a pilot program called PreCheck, allowing regulators to begin reviewing new drug-manufacturing facilities while they are still being built. The goal is to catch problems early and cut the time it takes to get new drugs to market by as much as 14 months, according to CNBC.
Eli Lilly and Regeneron are among seven companies selected for the inaugural cohort, announced June 29, 2026. Other participants include Amneal, Cellares, Fujifilm Biotechnologies, Kriya Therapeutics, and Kyowa Kirin, according to Reuters.
How PreCheck Works and What It Changes
Under the old system, companies built a facility first, then waited for the FDA to review it — often discovering problems too late. PreCheck flips that model. The FDA now sends inspectors and technical experts to a site while construction is still underway, giving companies a chance to fix issues before they become costly delays.
The program has two parts: a "facility readiness" track and an "application submission" track. The FDA provides technical guidance, faster feedback, and timeline evaluations. Acting FDA Commissioner Kyle Diamantas said the program ensures "American pharmaceutical manufacturers remain global leaders while securely providing high-quality treatments to patients right here at home," according to Hoodline.
Lilly's Lebanon Plant to Produce GLP-1 Drug Ingredients
Eli Lilly's site in Lebanon, Indiana, was chosen for PreCheck because it will produce the main ingredients for GLP-1 drugs — the active compounds in weight-loss and diabetes treatments like Zepbound and Mounjaro. Shortages of these drugs have been a persistent problem, and the Lebanon plant could help ease that crunch by late 2027.
The Lebanon facility is part of a much larger push by Lilly. CEO David Ricks pledged $27 billion to build four new U.S. manufacturing sites — the biggest expansion in the company's history, according to Miami Herald. Ricks has said his "optimism" in the U.S. pipeline drives the company's $50 billion in total capital expansion since 2020.
Regeneron's $2 Billion New York Site Joins the Pilot
Regeneron's PreCheck facility is a $2 billion manufacturing plant in Saratoga Springs, New York, announced in November 2025 alongside Governor Kathy Hochul. CEO Leonard Schleifer said the site would "nearly double" Regeneron's manufacturing capacity to fulfill the promise of their science, according to Star-Telegram.
The Saratoga Springs plant focuses on next-generation protein therapeutics — complex drugs made from living cells. Together, Lilly and Regeneron's expansions are estimated to create more than 14,000 jobs, including 3,000-plus permanent positions and 11,000-plus construction roles.
A Policy Shift Driven by Supply Chain Fears and Tariff Pressure
PreCheck is part of a broader push by the Trump administration to bring drug manufacturing back to the U.S. Today, only 11% of active pharmaceutical ingredient makers — the companies that produce the core chemical in a drug — are based in the United States, the FDA says. Over 80 companies applied for the pilot's first cohort, a signal of intense industry demand for faster regulatory timelines.
International firms like Kyowa Kirin and Fujifilm Biotechnologies are also participating. Analysts say the administration's threat of up to 25% tariffs on imported drugs is pushing foreign companies to build on U.S. soil to keep market access. HHS Secretary Robert F. Kennedy Jr. framed it plainly: "President Trump is rebuilding America's pharmaceutical manufacturing base because our nation's health and security depend on it," according to Sacramento Bee.
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