FDA Awards First-Ever National Priority Vouchers to Nine Sponsors

The U.S. Food and Drug Administration today announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.

Voucher recipients will receive a decision within 1-2 months following filing of a complete application for a drug or biologic. In addition, sponsors will receive enhanced communications with review staff throughout the development process prior to their final submission and during the review period. If necessary, FDA scientists reserve the right to extend the review time if an application is incomplete, there are manufacturing violations, or as they otherwise deem appropriate.

President Trump today celebrated the FDA awarding a voucher for the infertility product Pergoveris. “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,” the President said at his Improving Fertility Care and Expanding Access to IVF for Americans news conference.

“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,” said FDA Commissioner Marty Makary, M.D., M.P.H. “We must modernize the review process and try new approaches to meet the needs of the American people.”

The new CNPV process accelerates the standard 10-12 month timeline by convening a multidisciplinary team of physicians and scientists for a team-based review, interacting frequently with the sponsor to clarify questions, and completing review of the application concurrently. Once all streamlined review steps are complete, the team will convene for a 1-day “tumor board style” meeting.

Each drug review division within the FDA has been charged with nominating a product that they believe meets the stated national priority goals of the program. Sponsors can also apply and have their request reviewed by the designated review division.

The following products were selected:

• 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 for general anesthesia
• Augmentin XR for domestic manufacturing of a common antibiotic

The agency anticipates announcing another group of CNPV recipients in the coming months.