The U.S. Food and Drug Administration (FDA) has named nine recipients of the new Commissioner’s National Priority Voucher (CNPV) pilot program. The initiative aims to accelerate the review of products that address significant national priorities, including unmet medical needs, public health crises, and efforts to reduce health care costs.
Under the CNPV program, companies whose products are selected will receive a decision within one to two months after submitting a complete application for a drug or biologic. The FDA will also provide enhanced communication with review staff throughout product development and during the review period. However, the agency may extend review times if applications are incomplete, manufacturing violations occur, or as deemed necessary by FDA scientists.
At a news conference focused on improving fertility care and expanding access to IVF, President Trump highlighted the award of a voucher to Pergoveris, an infertility product. “This drug would directly compete against a much more expensive option that currently has a monopoly in the American market, and this will bring down costs very significantly,” he said.
FDA Commissioner Marty Makary, M.D., M.P.H., stated, “One of our core goals is to deliver more cures and meaningful treatments—especially ones that have an outsized impact on our most pressing national priorities. We must modernize the review process and try new approaches to meet the needs of the American people.”
The CNPV process is designed to shorten the standard 10-12 month review timeline. It brings together multidisciplinary teams for team-based reviews, frequent interactions with sponsors, and concurrent application review steps. Once these steps are completed, the team will hold a one-day “tumor board style” meeting to finalize decisions.
Each FDA drug review division nominated products that align with the program’s goals. Sponsors could also apply directly for consideration.
The nine selected products are:
- Pergoveris for infertility
- Teplizumab for Type I diabetes
- Cytisinicline for nicotine vaping addiction
- DB-OTO for deafness
- Cenegermin-bkbj for blindness
- RMC-6236 for pancreatic cancer
- Bitopertin for porphyria
- Ketamine for domestic manufacturing of a critical drug used in general anesthesia
- Augmentin XR for domestic manufacturing of a common antibiotic
The FDA plans to announce additional voucher recipients in the coming months.
