The FDA has 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 healthcare 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.”
FDA commissioner Marty Makary touted the initiative as an attempt to “deliver more cures and meaningful treatments,” thereby “modernizing the review process.” The new 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.”
Products for infertility, type 1 diabetes, nicotine vaping addiction, deafness, blindness, pancreatic cancer, porphyria, domestic manufacturing of a critical drug for general anesthesia, and domestic manufacturing of a common antibiotic were selected.
