On October 16, 2025, the Food and Drug Administration (FDA) unveiled the first group of nine voucher recipients under the Commissioner’s National Priority Voucher (CNPV) pilot program, a program announced by the agency earlier this year that provides a path for accelerated drug review for companies supporting national interests as determined by the Commissioner. The identified areas of priority by the agency include meeting large unmet medical needs, bolstering domestic manufacturing and increasing the affordability of medicines for American patients. As previously noted, the new program, which is not defined in statute or regulations, aims to significantly speed up FDA’s standard 10-12 month review timeline to just 1-2 months after filing an application for a drug or biologic. The agency has touted the benefit of recipients of the vouchers receiving enhanced access with FDA review staff and a “team-based review” model.
The nine voucher recipients span sponsors developing treatments related to infertility (Pergoveris), Type I diabetes (Teplizumab), nicotine vaping addiction (Cytisinicline), deafness (DB-OTO), blindness (Cenegermin-bkbj), pancreatic cancer (RMC-6236), and porphyria (Bitopertin). The first cohort announced by the agency also includes sponsors seeking to increase domestic drug manufacturing (ketamine, for general anesthesia, and Augmentin XR, a common antibiotic).
In announcing the first nine sponsors to receive the CNPV the agency reiterated that the awarding of the vouchers does not guarantee any regulatory outcome. The agency also provided additional insight into the CNPV selection process, noting that each drug review division within the agency was charged with nominating a product that they believe meets the stated goals of the program in addition to sponsors having the opportunity to apply for a voucher. While it is not clear how many total CNPVs will be awarded, FDA also noted in its announcement that the agency intends to announce additional CNPV recipients in the coming month, indicating additional vouchers are forthcoming. As with any new program or incentive that has the potential to accelerate drug development and review timelines, the interest in the agency’s implementation of the program will continue as additional details are made available.