Last week, the U.S. Food and Drug Administration (FDA) announced nine voucher recipients under the new Commissioner’s National Priority Voucher (CNPV) pilot program. The program was announced in June to accelerate approvals for companies aligned with “critical U.S. national health priorities.”
In the press release, the FDA explained that each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream healthcare utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with Most Favored Nation pricing.
According to the FDA, voucher recipients will receive a decision within 1-2 months, reduced from 10-12 months, after submitting a complete application for a drug or biologic. Additionally, sponsors will have improved communication with review staff throughout the development process before their final submission.
Each drug review division within the FDA was responsible for nominating a product it considered to meet the program's goals.
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
Another group of CNPV recipients is expected to be announced in the coming months.
