Amid an outpouring of industry investments in U.S. drug production, the FDA has launched a new program designed to significantly reduce the complexities involved in setting up domestic manufacturing plants.
Over the weekend, the FDA formally launched its PreCheck pilot program, announcing that it’s now taking requests from manufacturers hoping to participate.
The FDA first revealed that it was working on the PreCheck program last summer. In essence, the program seeks to improve communication between the industry and the FDA at earlier stages of the facility design process, all in a bid to make the build-out of new manufacturing sites less onerous. After unveiling the program early last August, the FDA sought feedback on how to best tailor the PreCheck program to the industry’s needs.
The program was launched within the context of President Donald Trump’s import tariff threats and frequent rhetoric from members of the administration about the need to restore the U.S.’ manufacturing autonomy.
"After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back," FDA Commissioner Marty Makary, M.D., said in a statement Sunday. "The PreCheck program is one of several powerful incentives we are providing to make the U.S. pharmaceutical manufacturing sector more resilient and competitive."
With the program now officially debuted, the FDA will select an initial cohort of new production facilities and begin conducting PreCheck activities this year. Those plants will be picked for participation “based on overall alignment with national priorities across multiple selection criteria,” the FDA explained.
PreCheck program requirements
The specific products to be manufactured, as well as the phase of development at the up-and-coming facilities and the innovation and speed on display at the sites, will factor into the FDA’s selection process, the regulator added. Facilities aiming to manufacture critical medicines for the U.S. market will also be given “priority consideration,” the FDA said in its announcement.
Those criteria resemble the rationale laid out in the Commissioner’s National Priority Voucher pathway the FDA launched last year. The vouchers, which award significantly expedited review timelines to drugs that align with “U.S. national priorities,” have quickly proven controversial, with some lawmakers warning that the program is prone to corruption.
The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit requests to take part in the program. Companies are limited to one submission for a single new U.S. production plant, according to the website.
To be eligible for the program, the plant applying must be new, rather than an expansion, and the company must have already broken ground on the project or plan to during the PreCheck discussions.
Qualifying plants must also be designed to “produce sufficient volume to meet a specified market need,” although exceptions will be made in the case of capacity for rare disease drugs treating a limited patient population, or sites that significantly contribute to broader U.S. supply needs.
Lastly, aside from the obvious requirement that the plant be in the U.S., the company applying must submit an application for a new drug or biologic, or manufacturing components or drug ingredients from the new plant, during participation in the PreCheck program. Companies that enroll in the program also need to commit to manufacturing products at their facility for “at least 3 years” after FDA approval of the products made there during the program, the FDA said.
As for the types of manufacturing the FDA is prioritizing, the regulator seems especially interested in rewarding new facilities that commit to the production of active pharmaceutical ingredients and drug substance as well as those that pledge to use only U.S.-sourced API and drug substance.
PreCheck phases
The program is broken down into two phases. During the first, known as the Facility Readiness Phase, selected manufacturers will interact with the FDA for early technical advice before their facilities are operational. In the second phase, known as the Application Submission Phase, the FDA and the industry will leverage pre-submission meetings and inspections to resolve problems and streamline assessments of manufacturing information included in drug applications.
As the FDA’s release of a trove of complete response letters last year illustrated, many of the regulator’s drug rejections come down to manufacturing concerns, especially in cases where companies are using third-party production partners.
Decoupling site inspections from the point after regulatory applications are submitted was a major piece of feedback the industry provided to the FDA when it was seeking council on PreCheck, Christopher Shilling, chief regulatory officer at gene therapy CDMO Forge Biologics, told Fierce Pharma in an interview about the program last year.
The FDA’s broader efforts to streamline facility construction come as myriad large drugmakers have pledged to erect new plants in the U.S., largely in response to Trump’s campaign of tariff threats.
Most recently, Eli Lilly on Friday unveiled plans for a new $3.5 billion injectable and device factory in Pennsylvania’s Lehigh Valley. The facility—which will crank out next-generation weight loss drugs, among others—marks the last of four Lilly said it would build when it announced a $27 billion investment in its U.S. operations at an event dubbed “Lilly in America” last February.