Eli Lilly, Regeneron join FDA pilot to speed factory inspections

The FDA picked seven drugmakers for a pilot program that lets companies clear manufacturing inspections before submitting a new drug application. Eli Lilly and Regeneron are the only two named participants. The other five firms cover a mix of branded and generic producers, the agency said without identifying them.

The PreCheck Pilot Program is voluntary. Companies that sign up agree to give the FDA early access to their facilities and quality data. In return, the agency promises a quicker review cycle for drugs or line extensions made at those plants. The goal is to reduce the backlog of pending applications and give manufacturers more certainty about when they can start commercial production.

Drug shortages have been a persistent problem for the U.S. healthcare system. The pandemic showed how heavily the country relies on overseas factories for active ingredients and finished doses. India and China supply roughly 80% of the raw materials used in American generic drugs. When those supply chains break, hospitals scramble for alternatives. Congress and patient groups have pushed the FDA to do more to support domestic capacity.

The PreCheck program is one piece of that effort. It does not guarantee a company will build a new plant in the U.S. Yet it lowers the regulatory risk of doing so. A manufacturer that knows its facility can pass FDA review before breaking ground is more likely to invest in domestic capacity, the agency has argued.

Both Eli Lilly and Regeneron have recent experience with manufacturing delays. Lilly struggled to ramp up production of its blockbuster diabetes drug Mounjaro in 2023, partly because of FDA inspection bottlenecks. Regeneron faced similar constraints when it tried to scale up its Covid antibody treatment during the emergency use authorization period. Both companies have since expanded their internal manufacturing teams.

The pilot runs for an initial period. The FDA did not specify a duration. If the model works, the agency could expand it to more companies and eventually make it a permanent part of the review process. For now, the seven participants will test whether early factory reviews can speed up drug approvals without cutting corners on quality.

The broader macro read involves supply chain resilience and healthcare inflation. Faster domestic approvals mean less reliance on foreign plants and fewer shortages that push up costs for hospitals and insurers. The program remains small: seven companies out of hundreds of drugmakers will not transform the landscape overnight. It is a step, not a solution.