The U.S. Food and Drug Administration has launched the Commissioner’s National Priority Voucher pilot program, awarding nine sponsors priority review vouchers to accelerate approval of drugs and biologics addressing major national health priorities. The program targets products with potential to meet unmet medical needs, reduce downstream health‑care utilization, respond to public‑health crises, promote domestic manufacturing, or enhance affordability through Most Favored Nation pricing.
Under the Commissioner’s National Priority Voucher process, sponsors will receive a decision within 1 to 2 months following submission of a complete application. The program also provides enhanced communication between sponsors and FDA review teams during development and evaluation. The U.S. Food and Drug Administration may extend review timelines for incomplete applications, manufacturing issues, or other scientific concerns.
At a press event focused on expanding fertility care, President Trump noted that the infertility therapy Pergoveris, “would directly compete against a much more expensive option.” The U.S. Food and Drug Administration Commissioner Marty Makary, MD, MPH, stated that “we must modernize the review process and try new approaches to meet the needs of the American people.”
The Commissioner’s National Priority Voucher framework reduces the traditional 10- to 12-month review period by implementing a concurrent, multidisciplinary, team-based review involving physicians and scientists. The process concludes with a 1-day “tumor board style” meeting to finalize evaluations.
Selected products include Pergoveris (infertility); teplizumab (Type 1 diabetes); cytisinicline (nicotine vaping addiction); DB-OTO (deafness); cenegermin-bkbj (blindness); RMC-6236 (pancreatic cancer); bitopertin (porphyria); ketamine (to support domestic production of anesthetic agents); and Augmentin XR (to support antibiotic manufacturing).
Each U.S. Food and Drug Administration review division nominated at least one product aligned with the program’s goals, and sponsors may apply for consideration through their respective divisions. The agency anticipates announcing additional voucher recipients in the coming months as the pilot expands.
