The fastest way to get medicines to market is to make approval smarter
In a quiet but consequential shift, the U.S. Food and Drug Administration has launched a pilot program called PreCheck, inviting seven major pharmaceutical manufacturers — among them Eli Lilly and Regeneron — into a more collaborative model of facility review. Rather than waiting until a plant is built to discover problems, the agency is moving upstream, shaping the process before the concrete is poured. It is a recognition, long overdue in some quarters, that the machinery of regulation can itself become an obstacle to the medicines people need.
- Months or years of regulatory waiting have long delayed when newly approved drugs can actually reach patients — PreCheck is the FDA's attempt to break that pattern.
- By reviewing manufacturing facilities before they are fully operational, the agency can catch problems early rather than derail entire production timelines at the finish line.
- Seven companies, including Eli Lilly and Regeneron, have been selected as the pilot's first participants — a signal of which manufacturers the FDA sees as anchors of American drug production.
- The initiative arrives amid growing pressure on the FDA to prove it can modernize without compromising safety, and amid broader anxieties about supply chain vulnerability.
- If the pilot delivers on its promise, PreCheck could expand into a standard feature of how the agency handles new facilities — reshaping the regulatory landscape for the entire industry.
The FDA has launched PreCheck, a pilot program designed to reduce the regulatory delays that slow the approval of new pharmaceutical manufacturing plants. Seven major drug makers have been selected as its first participants, including Eli Lilly and Regeneron — companies whose manufacturing ambitions make faster approvals especially valuable.
Historically, companies have waited months or even years for the agency to sign off on new production sites, delays that postpone when drugs reach patients and create supply chain bottlenecks. PreCheck changes the sequence: the FDA will conduct preliminary reviews before facilities are fully built, identifying problems early rather than discovering them during a final inspection that could collapse an entire timeline.
The selection of participants signals which players the FDA considers central to strengthening American drug production — a concern sharpened by recent supply chain vulnerabilities. The program is not a blanket acceleration but a structured experiment with manufacturers already proven to meet high standards.
What PreCheck ultimately represents is a shift in philosophy: an acknowledgment that the regulatory process itself can be a bottleneck, and that making approval smarter may matter as much as making it faster. The pilot will be watched closely — by competitors hoping to join, and by the FDA itself, gathering evidence on whether the approach delivers without introducing new risks.
The Food and Drug Administration has launched a new pilot program designed to cut through the regulatory delays that typically slow the construction and approval of pharmaceutical manufacturing plants. The initiative, called PreCheck, has selected seven major drug makers as its first participants, including Eli Lilly and Regeneron, two of the largest names in the industry.
The program represents a deliberate shift in how the FDA approaches one of its core functions: inspecting and approving the facilities where medicines are actually made. Historically, companies have had to wait months or years for the agency to review and sign off on new manufacturing sites before they could begin production. Those delays ripple outward—they postpone the moment when a newly approved drug can reach patients, and they create bottlenecks in the supply chain when manufacturers want to expand capacity or bring production home from overseas.
By bringing companies into PreCheck, the FDA is essentially offering them a faster track. The agency will conduct preliminary reviews of manufacturing facilities before they're fully built or operational, allowing problems to be identified and corrected early rather than discovered during a final inspection that could derail an entire timeline. The companies involved get clearer guidance on what the FDA expects, and the agency gets a chance to shape the process from the beginning rather than react to it at the end.
Eli Lilly and Regeneron are household names in pharma circles, but the pilot includes five other major manufacturers as well. These are companies with the resources to participate in a pilot program and the manufacturing ambitions that make faster approvals valuable. The selection signals which players the FDA sees as central to strengthening American drug production capacity—a concern that has grown more acute in recent years as supply chain vulnerabilities have become apparent.
The timing matters. The pharmaceutical industry has been pushing for regulatory modernization for years, and the FDA has been under pressure to prove it can move faster without sacrificing safety. PreCheck is a measured response: it's not a blanket acceleration, but a structured experiment with companies that have already demonstrated their ability to meet high standards. If it works, the model could be expanded beyond the pilot phase to include more manufacturers and potentially become a standard part of how the agency handles new facilities.
What PreCheck signals is a recognition that the regulatory process itself can be a bottleneck, and that sometimes the fastest way to get medicines to market is to make the approval process smarter, not just faster. The companies in the pilot will be watched closely—not just by competitors hoping to join, but by the FDA itself, which will be gathering data on whether this approach actually delivers on its promise to accelerate drug manufacturing reviews without creating new risks.
The Hearth Conversation Another angle on the story
Why does it matter how fast the FDA reviews a manufacturing plant? Isn't the safety inspection the important part?
Both things are true. Safety is non-negotiable. But the inspection itself doesn't have to happen at the end of the process, when everything is already built. PreCheck lets the FDA review plans and designs early, so problems get caught and fixed before construction is done. That's actually safer and faster.
So these seven companies get special treatment?
Not special treatment—early collaboration. They're working with the FDA from the start instead of hoping for approval after the fact. It's a different relationship, not a shortcut.
What happens if the pilot fails? If something goes wrong?
Then the FDA learns what doesn't work and adjusts. But the real risk isn't in the pilot—it's in the status quo. Every month a manufacturing plant sits waiting for approval is a month patients can't access a drug that's already been proven safe and effective.
Will other companies want in?
Almost certainly. If PreCheck actually cuts months off the timeline, every manufacturer will want to participate. That's when the FDA has to decide whether to expand it or keep it limited.