On November 11, 2025, leading pharmaceutical manufacturers and industry representatives intensified their push for the U.S. Food and Drug Administration (FDA) to expand its PreCheck program to include existing manufacturing facilities, not just new construction projects. The PreCheck program, introduced earlier this year, was designed to incentivize the building of new pharmaceutical manufacturing sites in the United States by offering earlier regulatory interactions and streamlined approval pathways. However, industry leaders argue that the program’s current focus on new facilities overlooks a significant opportunity to activate idle capacity at existing plants, which could rapidly increase domestic drug production and reduce reliance on imports.

At a recent FDA meeting, representatives from companies such as Sanofi, Forge Biologics, Eli Lilly, and B. Braun Medical voiced strong support for broadening PreCheck eligibility. They emphasized that the U.S. already possesses substantial unused manufacturing capacity, particularly in the generics sector. A 2022 survey of 37 U.S. pharmaceutical manufacturing sites, representing nearly 25% of the country’s generic drug production infrastructure, found that 30% of these sites were operating at less than half of their capacity. The study estimated that nearly 60% of this unused capacity could be brought online within a year, potentially producing an additional 30 billion doses annually without the need for new construction.

Industry executives highlighted the economic and logistical advantages of activating existing facilities. Kevin Webb, president and chief operating officer at the API Innovation Center (APIIC), stated that repurposing manufacturing lines at idle sites could cost as little as a few million dollars and be completed in one to two years, compared to the decade-long timeline and $700 million to $1 billion investment required for a new facility. Kamaal Anas, corporate vice president for regulatory affairs at B. Braun Medical, echoed this sentiment, noting that building a new plant takes five to seven years, while adding a new line to an existing facility can be done in three to five years.

The Association for Accessible Medicines (AAM), a trade group representing generic and biosimilar drug manufacturers, also expressed interest in the applicability of PreCheck to existing plants. The group argued that leveraging dormant capacity is the fastest and most cost-effective way to increase domestic output and mitigate ongoing drug shortages. Representatives from Sanofi and Forge Biologics further stressed the importance of regulatory support for technology transfers, product launches, upgrades, and reconfigurations at existing facilities, which are critical for maintaining flexibility and responsiveness in the supply chain.

Despite these compelling arguments, FDA officials have not yet committed to expanding the PreCheck program. During the meeting, agency representatives indicated that the program was primarily designed for new facilities to encourage investment in U.S. manufacturing. However, they acknowledged the industry’s concerns and stated that comments would be taken under consideration. The FDA stopped accepting written feedback on the PreCheck program on October 30, and it remains unclear when or if the agency will announce any changes to the program’s scope.

The push for PreCheck expansion comes amid growing scrutiny of the U.S. pharmaceutical supply chain and increasing pressure to reduce dependence on foreign manufacturing. By unlocking idle capacity at existing facilities, the industry could quickly address shortages, enhance supply chain resilience, and support the broader goal of onshoring critical drug production. As the FDA weighs its next steps, the outcome of this debate could have significant implications for the future of pharmaceutical manufacturing in the United States.