SHERIDAN, WYOMING - November 13, 2025 - Drug manufacturers are urging the FDA to broaden its proposed PreCheck program beyond new factory construction, warning that excluding existing facilities could slow U.S. efforts to expand pharmaceutical production capacity. At a recent agency meeting, representatives from companies spanning gene therapy, generics, and biologics argued that PreCheck's current scope overlooks the fastest route to alleviating drug shortages and strengthening domestic supply chains.
Early-Stage Regulatory Support Designed Only for New Sites
PreCheck was introduced to streamline the regulatory oversight of newly built manufacturing plants, giving participating companies earlier FDA engagement well before their first commercial product application. The program is meant to make U.S. construction more attractive by reducing uncertainty and aligning expectations early in the buildout process.
But industry leaders contend the initiative does not reflect operational realities. Many manufacturers are already expanding facilities, repurposing lines, or reactivating dormant operations-activities that require the same regulatory clarity as greenfield projects. Without PreCheck access, companies must wait until their license applications are filed to receive feedback, losing valuable time in facility readiness planning.
Operational and Technical Barriers for Existing Facilities
Companies that began construction before PreCheck was announced worry that, under current rules, they cannot benefit from the program's accelerated FDA interactions. While agency officials listened to stakeholder feedback during the September meeting, one employee indicated existing facilities may fall outside the intended scope, stating: "We're taking the comments under consideration. But I would just say at a high level that the program really is geared for new facilities to get folks to come here. If the facility is built and you've got a strong quality system, this program may not be the right program, and I think there's a lot of other avenues that can be considered."
Manufacturers argue that these "other avenues" do not provide consistent or early regulatory guidance, particularly during expansions, technology transfers, and modernization projects. For companies preparing to scale new modalities-biologics, AAV vectors, or complex sterile products-the lack of structured interaction with the FDA increases risk, cost, and timelines.
Industry Context: Idle Capacity and Supply Chain Vulnerabilities
A central theme raised at the meeting was the strategic value of reactivating dormant U.S. production lines. A 2022 analysis of 37 generic-drug manufacturing sites found that 30% operated at less than half their capacity, with nearly 60% of the unused lines capable of becoming operational within one year. That additional output-estimated at close to 30 billion doses annually-could ease chronic drug shortages more rapidly and more affordably than building new factories.
Executives pointed out that retrofitting an existing line can cost a few million dollars and take one to two years, versus $700 million to $1 billion and a decade of development for a new facility. For a generic or biosimilar market marked by tight margins and supply instability, those differences are transformative.
Stakeholder Perspectives from API, Generics, and Biologics Leaders
Industry groups across the manufacturing landscape-including the Association for Accessible Medicines-emphasized that U.S. plants with unused capacity represent a strategic asset in efforts to reduce import reliance. Leaders from Eli Lilly, Sanofi, and Forge Biologics presented scenarios showing how PreCheck access could accelerate product launches, technology transfers, and capacity upgrades at sites already under construction.
For emerging biomanufacturing players, early FDA engagement is especially important. Gene therapy service providers noted that as they move toward their first commercial applications, structured regulatory interaction could help them align quality, documentation, and facility standards more efficiently.
Strategic Implications for U.S. Manufacturers and Supply Chain Policy
If PreCheck remains restricted to new facilities, industry advocates warn the U.S. risks leaving its largest near-term manufacturing opportunity untapped. Existing plants could support:
- Rapid scaling of generic and biosimilar output
- Lower-cost modernization of sterile and biologics operations
- Faster activation of regional supply hubs
- Reduced exposure to international supply chain disruptions
However, the FDA has not committed to expanding eligibility, and with the comment period closed-and recent government shutdowns delaying policy activity-the timeline for next steps remains uncertain.
Learn More
Additional information on FDA policy updates and manufacturing-facility guidance can be accessed through the FDA's official website at https://www.fda.gov.