FDA opens PreCheck pilot to accelerate U.S. drug manufacturing

The U.S. Food and Drug Administration on February 1 began accepting requests to participate in a new PreCheck pilot aimed at accelerating construction and regulatory review of domestic pharmaceutical manufacturing facilities. The initiative is designed to increase regulatory predictability and encourage investment in U.S.-based production as part of wider efforts to strengthen supply-chain resilience.

PreCheck is a two-phase program. In Phase 1, the Facility Readiness phase, selected manufacturers will receive early technical advice from the agency before a facility is operational. FDA materials describe pre-operational reviews and the use of facility-specific Drug Master Files to evaluate manufacturing elements in advance of a drug application. Phase 2, the Application Submission phase, builds on that preparatory work with pre-submission meetings and inspections intended to resolve issues early and expedite assessment of manufacturing information included in product applications.

FDA Commissioner Marty Makary framed the program as part of a broader push to bring production back to the United States, saying, "After 35 years of globalists taking pharmaceutical manufacturing overseas, the FDA is taking bold steps to bring it back." Agency statements cited industry feedback from last year and emphasized goals to "increase regulatory predictability," facilitate construction of U.S. manufacturing sites and "protect patient safety through the implementation of the PreCheck Program."

The agency set a rapid timetable for the pilot. The application window opened on February 1 and runs through March 1, with finalists to be announced April 1 and given until May 1 to supply additional information. The FDA plans to select its initial cohort of PreCheck participants by June 30. The agency has directed prospective applicants to the FDA PreCheck web page for eligibility and selection criteria; some program materials were released with the Feb. 1 announcement and others remain pending.

Regulatory and industry advisers have urged companies to assess ongoing or planned facility projects now in order to prepare applications that highlight innovation, domestic benefits and contributions to supply-chain resilience. A law firm alert circulated before the launch recommended that potential applicants assemble technical and regulatory documentation and consider engaging outside advisors to shape application strategies.

The program responds to a policy push from the White House and Congress to move critical drug manufacturing back to the U.S. BioSpace and Reuters reporting linked PreCheck to an executive order from May that sought regulatory relief to incentivize domestic production. Reuters noted the FDA would weigh "alignment with national priorities" in selecting initial facilities, but did not specify how those priorities will be defined.

Key operational details remain unresolved. The FDA has not disclosed how many facilities will be accepted into the initial cohort, the precise eligibility or scoring criteria, or whether participation will guarantee fixed, accelerated review timelines for subsequent product approvals. Industry hopes the pilot will reduce uncertainty in design, construction and quality control planning by providing earlier, clearer regulatory feedback; regulators and independent experts will now be watched closely to see whether PreCheck delivers faster approvals without compromising inspection standards.

For now, the agency has published contact information and directed interested firms to its PreCheck web page for application materials and further guidance.