The Commissioner’s National Priority Voucher (CNPV) program is designed to shorten the review times of complete submitted New Drug Applications (NDAs) and Biologics License Applications (BLAs) from a standard ten months to two months.  We have written previous blogs on this topic as can be seen here, here, and here and have expressed some concerns regarding how the FDA could meet the proposed timelines as well as how program participants would be selected for receipt of the vouchers.  The FDA originally announced that it would issue “no more than five” vouchers for the first year (2025).  However, despite this, the FDA’s announcement (here) indicated that nine vouchers have been awarded.

The first nine vouchers were awarded for the following products:

  • 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 breadth and scope of the awards represent the extent of the national health priorities demonstrated by this program including domestic drug development, products to substantially reduce patient costs, disease states without current treatments or where treatments are less than optimal, and a product to help with nicotine addiction.

In addition, the FDA announcement stated that “[t]he agency anticipates announcing another group of CNPV recipients in the coming months.”  While the FDA’s stated plan was to offer five or fewer vouchers in the first round, the issuance of nine raises the question of how much these applications (if and when filed) will stress current FDA resources.  In the announcement, the Agency also indicated that more vouchers will be on the way!  This raises a couple of questions.  First, will the FDA be able to meet the review goals for the existing voucher recipients with its remaining resources?  And, second, how will non-voucher NDAs and BLAs be affected by the increased number of vouchers awarded?  After all, every sponsor of every NDA and BLA submitted to the FDA pays a rather hefty user fee with the expectation that the usual PDUFA goals will be met.  Will these CNPV applications, when submitted, put all other non-voucher applications under review at a disadvantage?

Obviously, we can only speculate about the potential impact that the new CNPV program may have on non-voucher sponsors and we will not have a firm idea until sometime in the next year or so.  Today, expedited reviews of certain applications have been allowed, but the unanswered question is how much strain will these voucher applications place on the current review paradigm and, if standard PDUFA goals are negatively impacted by the program, how will the industry and the FDA react?  Recently, the industry has been surprised by the increase in number of complete response letters being issued for NDAs and BLAs, and has seen more goal-date extensions for the FDA to complete its review of applications.  If these CRL and review-extension metrics worsen in response to the voucher program’s resource requirements, it will be interesting to see how the industry reacts.