9 Drugs Granted Fast Track By FDA's Voucher Program
By Katie Anderson, Chief Editor, Pharmaceutical Online
Nine drugs have been given vouchers under FDA Commissioner Makary’s new National Priority Voucher (CNPV) Program. With targets like pancreatic cancer, deafness, blindness, infertility and vaping addiction, these drugs were chosen due to an unmet need, addressing a public health crisis, boosting domestic manufacturing or increasing affordability.
The nine drugs selected were:
- 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
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.
“We must modernize the review process and try new approaches to meet the needs of the American people,” “noted FDA Commissioner Marty Makary, M.D., M.P.H. in an FDA press release.
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 agency anticipates announcing another group of CNPV recipients in the coming months. 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.