As investment pours into expanding pharmaceutical manufacturing capacity within the U.S., the FDA has introduced a new initiative aimed at easing the regulatory and logistical hurdles involved in building domestic production facilities.
The agency officially rolled out its PreCheck pilot program and said it is now accepting participation requests from manufacturers interested in joining the effort.
The FDA first disclosed plans for PreCheck last summer. The program is intended to strengthen early-stage collaboration between regulators and drugmakers during facility planning and design, with the goal of streamlining the construction of new manufacturing sites. After announcing the concept in early August, the agency requested industry input to help shape the program around manufacturers’ practical needs.
The launch of the initiative comes amid President Donald Trump’s tariff threats on imports and repeated statements from administration officials emphasizing the need to rebuild U.S. manufacturing independence.
FDA Commissioner Marty Makary said in a statement Sunday that decades of outsourcing drug production abroad had weakened domestic manufacturing and that the FDA is now pursuing decisive measures to reverse that trend. He noted that the PreCheck program is among several incentives intended to strengthen the resilience and competitiveness of pharmaceutical manufacturing within the country.
Now that PreCheck has formally launched, the FDA said it will identify an initial group of new manufacturing facilities to take part and begin program activities later this year. According to the agency, participating sites will be chosen based on how closely they align with national priorities, using a range of selection factors.
The FDA said several factors will influence which facilities are chosen for the program, including the types of products planned for manufacture, the development stage of those products, and the degree of innovation and speed demonstrated at the sites. Facilities intending to produce medicines considered essential for the U.S. market will receive heightened priority, according to the agency.
Those selection principles mirror the logic behind the FDA’s National Priority Voucher pathway introduced last year. That program offers sharply accelerated review timelines for drugs deemed to advance U.S. national interests, but it has already drawn criticism, with some lawmakers cautioning that the approach could be vulnerable to corruption.
The FDA detailed eligibility requirements for the PreCheck initiative on a dedicated webpage that also allows companies to apply for participation. Under the program rules, each company may submit only one application, and it must pertain to a single new manufacturing facility located in the U.S.
To qualify, the facility must be a new build rather than an expansion of an existing site. In addition, the applicant must have already begun construction or be prepared to break ground while engaged in PreCheck discussions.
Eligible facilities must also be designed with enough production capacity to satisfy a defined market demand. However, the FDA said it will allow flexibility for sites manufacturing therapies for rare diseases with small patient populations, as well as for facilities that play a critical role in strengthening the overall U.S. drug supply.
