The FDA has established a new priority review program for premarket applications for pharmaceuticals that reflects the agency’s health priorities. Under this program, the premarket review process could be limited to as little as one to two months following the submission of a complete premarket application.
The FDA stated in its June 17 press release that the Commissioner’s National Priority Vouchers (CNPV) program requires that
participating drug manufacturers submit much of the data for a drug application before the pivotal clinical trial is completed. FDA commissioner Marty Makary said the ultimate goal of the CNPV program is “to bring more cures and meaningful treatments to the American public.” The agency listed four criteria for eligibility, including whether a drug product addresses a health crisis or an unmet public health need. However, any application that would increase domestic drug manufacturing may also be eligible, given the emphasis on domestic manufacturing as a national security issue.
The CNPV program would drastically reduce the review time for pharmaceutical premarket applications from 10-12 months to one to two months. This would require, however, that the sponsor file chemistry, manufacturing, and controls (CMC) data and the proposed product label at least 60 days prior to filing the completed application. The FDA would review the completed application in a process similar to the process used by the agency’s Oncologic Drugs Advisory Committee, which typically calls for a single-day advisory committee meeting to review the application.
Prior to that meeting, a multidisciplinary group of FDA staff would convene to review the application. This would replace the conventional review process, which may involve serial review of the application by multiple offices at the product center of jurisdiction. The manufacturer must rapidly respond to any FDA queries about the data reviewed under the CNPV program, however. The 60-day window for review data prior to the filing of the completed application can be extended for several reasons, such as when the application presents exceptionally complex regulatory questions or when the results of the pivotal trial are ambiguous. A CNPV voucher will expire after two years.
Manufacturers can apply for vouchers for a specific pharmaceutical product or for an undetermined new drug product, but the FDA will limit the number of vouchers it will issue in the first year of the program. The agency did not state how many of these vouchers it will issue in 2025. The manufacturer can apply for entry into the program at any stage of drug development, but the program is not open to medical devices or combination products.
According to an FAQ posted with the FDA statement, the vouchers are not transferrable from one drug manufacturer to another, but will remain valid in the event of a change in company ownership. The agency will operate the CNPV as a pilot program for 2025, and the FDA said it may increase the number of vouchers in 2026.
While the CNPV program incorporates elements of other FDA priority review programs, it does not replace any of those other programs. It can, however, be used in conjunction with these other programs, such as the drug accelerated approval program, which provides accelerated reviews for disease categories like cancer. More than 60 therapies have been approved for cancer indications under the accelerated review program, while manufacturers have withdrawn 31 applications for cancer therapeutics. Unlike the CNPV program vouchers, the vouchers for the accelerated drug approval program can be sold by the holder to another pharmaceutical manufacturer.
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