Fourteen Months Off the Clock
The U.S. Food and Drug Administration has launched the PreCheck pilot program, a move aimed at accelerating the approval of domestic pharmaceutical manufacturing facilities. By shifting oversight to the construction phase, the agency estimates that participating firms could save up to 14 months, according to FDA spokesperson Benjamin Nichols.
A Seven-Firm Pilot Cohort
The FDA has tapped seven companies for this initial rollout, favoring firms that address market supply gaps or target unmet medical needs. The cohort represents a mix of industry giants and specialized biotechnology players:
- Eli Lilly: A facility in Indiana focused on the production of the main ingredients of GLP-1 pills and shots.
- Regeneron: A $2 billion investment site in New York producing biologic drug substance, sterile injectables and protein therapeutics.
- Fujifilm Biotechnologies: A facility in North Carolina currently producing monoclonal antibodies.
- Amneal Pharmaceuticals: A New York-based site dedicated to small molecule sterile liquid products.
- Cellares: A New Jersey facility specializing in cell-based gene therapies.
- Kriya Therapeutics: A North Carolina plant focused on adeno-associated virus-based gene therapies.
- Kyowa Kirin: A North Carolina site producing biologics for rare diseases.
Regulatory Oversight During Construction
PreCheck operates on two components: facility readiness, where the FDA gives the companies technical guidance before the site opens, and application submission, where participants can get more hands-on feedback from the FDA and expedited inspections and facility evaluation.
Fujifilm Biotechnologies expects this to facilitate an operational readiness review before the end of this year, and it expects the program will allow its customers to explore faster approval pathways with the FDA.
Shoring Up the Domestic Supply Chain
The initiative is a clear effort to stabilize the domestic pharmaceutical supply chain.
Eli Lilly noted it is “evaluating how PreCheck and related regulatory improvements may impact the facility’s timeline and will continue to work closely with FDA to support the program’s success.” Regeneron CEO Leonard Schleifer said the program encourages the collaboration required to “build next generation manufacturing capabilities and strengthen America’s biopharmaceutical industry.”
Strict Criteria for Participation
Eligibility for PreCheck is narrow. Companies must build a new manufacturing facility capable of making drugs that would address a market supply gap or improve access to therapies for unmet medical needs. The expedited review does not apply broadly; it covers only products that rely on the facility. Currently, the program is heavily weighted toward complex, high-precision manufacturing, such as biologic drugs and genetic medicines.