As reported on FiercePharma, the U.S. Food and Drug Administration (FDA) has selected seven pharmaceutical and biotechnology companies to participate in its newly established PreCheck Pilot Program, an initiative aimed at strengthening domestic drug manufacturing and improving supply chain resilience. The selected participants include Eli Lilly, Regeneron, Fujifilm, Cellares, Amneal Pharmaceuticals, Kyowa Kirin, and Kriya Therapeutics.
The program arises amid renewed federal emphasis on bolstering U.S.-based production of essential medicines. By fostering earlier collaboration between regulators and drug manufacturers, the FDA aims to streamline the development and approval process for facilities that will supply the American market.
Enhancing Regulatory Efficiency
At its core, the PreCheck Pilot is designed to reduce the regulatory uncertainty and delays often associated with establishing new manufacturing plants. Traditionally, manufacturing-related issues are identified late in the approval process, sometimes during pre-approval inspections, leading to costly delays or regulatory setbacks. The new program addresses this by shifting FDA engagement to much earlier stages of facility development.
Through this proactive approach, the FDA estimates that review timelines could be shortened by as much as 14 months. Participating companies will benefit from a more predictable pathway, potentially accelerating the availability of therapies to patients.
Each selected company is currently constructing a manufacturing facility and has committed to submitting regulatory applications, such as New Drug Applications (NDAs), Biologics License Applications (BLAs), or Abbreviated New Drug Applications (ANDAs), that will depend on these sites. The therapies produced at these facilities are intended to address supply shortages or expand access to treatments for unmet medical needs.
Geographic Distribution of Facilities
The manufacturing sites included in the pilot span multiple states, reflecting a geographically diverse investment in U.S. biopharmaceutical infrastructure:
- North Carolina hosts three facilities: a large-scale cell culture biomanufacturing plant by Fujifilm in Holly Springs, a gene therapy production site developed by Kriya in Durham, and a Kyowa Kirin facility in Sanford focused on rare disease drug substances.
- New York is home to two sites: Regeneron’s drug substance and sterile injectable plant in Saratoga Springs, and Amneal’s sterile liquid manufacturing site on Long Island.
- New Jersey features Cellares’ cell therapy manufacturing facility in Bridgewater.
- Indiana will host Eli Lilly’s facility within its expanding active pharmaceutical ingredient (API) manufacturing campus in Lebanon.
A Two-Phase Framework
The PreCheck Pilot Program operates in two phases:
- Phase 1 focuses on facility readiness before sponsors submit formal drug applications, enabling early identification and mitigation of potential issues.
- Phase 2 involves pre-submission meetings and allows FDA inspections to occur earlier during the review cycle, helping to prevent last-minute complications.
This framework is intended to integrate manufacturing readiness into the broader regulatory process, reducing the likelihood of delays after application submission.
Policy Context and Industry Impact
The launch of the program follows a federal directive aimed at revitalizing domestic pharmaceutical production. Policymakers have increasingly prioritized reducing reliance on overseas manufacturing, particularly for critical medicines and advanced therapies.
Industry leaders view the initiative as a meaningful shift in regulatory strategy. By incorporating facility readiness into earlier stages of drug development, companies may avoid the risk of manufacturing issues becoming barriers to approval. This is especially significant for emerging platforms such as cell and gene therapies, where manufacturing complexity is a major challenge.
In addition to improving efficiency, the program is expected to support job creation and encourage investment in advanced manufacturing technologies within the United States.
Looking Ahead
The FDA evaluated applicants based on several factors, including the type of therapies to be produced, the stage of facility development, projected timelines for market entry, and the level of innovation in manufacturing approaches.
As the PreCheck Pilot progresses, it may serve as a model for broader regulatory reform aimed at modernizing pharmaceutical manufacturing oversight. If successful, the initiative could play a critical role in ensuring timely patient access to safe and effective treatments while reinforcing the resilience of the U.S. drug supply chain.
