On June 17, 2025, U.S. Food and Drug Administration (FDA) Commissioner Marty Makary announced that the agency is creating a new pilot program called the Commissioner’s National Priority Voucher (CNPV). The program is intended to shorten the application review time to one or two months for certain drug products that meet FDA’s stated priorities. These include: addressing a health crisis in the U.S.; delivering more innovative cures for the American people; addressing unmet public health needs; and increasing domestic drug manufacturing as a national security issue.
While the program is called a “voucher” program, it is categorically different than other voucher programs previously created by Congress. Under those statutorily authorized voucher programs, the applicant receives a transferable priority review voucher in exchange for developing and gaining approval of a drug that addresses a specific unmet need — pediatric disease, tropical disease or medical countermeasure. The transferability of the priority review voucher is the true incentive in those programs because priority review vouchers can be, and have been, sold — the highest price paid for such a voucher was $350 million in 2013. The prior voucher programs thus have been designed to offer developers a highly lucrative incentive to develop products in categories of drugs that otherwise would see little to no development activity.
The commissioner’s new program, in contrast, is more of a “designation” than a “voucher.” While FDA describes the program as giving vouchers to companies that are developing products that align with the agency’s stated priorities, the voucher cannot be transferred, and the recipient of the voucher must use it within two years after it is granted. Interestingly, FDA’s announcement indicates that the agency may independently grant vouchers to eligible product developers, in addition to applicants who apply to receive a voucher. FDA has not yet provided details about how to apply for a voucher.
While FDA likely would not have had the authority to independently create a voucher program similar to those established by Congress, the current pilot does appear to be within the agency’s authority. Dr. Makary has hinted at this program in public statements, and his vision appears to be of an intensive rolling application review process in which a targeted cross-functional FDA team undertakes an interactive process with the sponsor to quickly resolve questions about the full spectrum of information that is required to support approval. Dr. Makary’s theory is that if sponsors submit much of the required nonclinical information in advance, including labeling, FDA can review a product’s clinical efficacy data on a significantly compressed timeline — one to two months as opposed to six months, which is the shortest review timeline contemplated by the Prescription Drug User Fee Amendments (PDUFA). Dr. Makary has described the reviews he envisions as like a “tumor board,” a process in which a variety of specialists convene to collectively decide on a treatment plan for a cancer patient. In Dr. Makary’s analogy, the product application would be the patient, and the FDA review team would be the tumor board.
For companies that are developing products that may be eligible for this program, it could present an exciting opportunity to gain access to an expedited, interactive FDA review in an otherwise resource-strapped environment. Notably, the categories identified in FDA’s announcement are broad, and invite advocacy for why a sponsor may be well-positioned to participate in the voucher program. Perhaps more important, this program gives us a clear indication of FDA’s potential negotiating position heading into PDUFA VIII, as the end of the pilot — including the expiration dates of any vouchers granted — will coincide with PDUFA reauthorization. While we expect FDA’s position in negotiating PDUFA VIII will reflect Secretary Kennedy’s stated priority of reducing alleged conflicts of interest that arise from industry paying large fees for FDA review, if this pilot is successful, we may see much of the program codified in the PDUFA VIII commitment letter.
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