Commissioner's National Priority Voucher Program and Coverage Considerations
On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests. Specifically, the Commissioner's CNPV pilot program is designed to cut the typical 10- to 12-month review time down to one or two months. According to Commissioner Makary, vouchers would be granted to "a select group of products where the company has agreed to increase affordability, domesticate manufacturing as a national security issue, or address an unmet public health need."
The CNPV process requires voucher holders to submit the chemistry, manufacturing, and controls portion and proposed labeling at least 60 days prior to submitting the complete application, and a senior multidisciplinary committee led by FDA's Office of the Chief Medical and Scientific Officer would review the information prior to convening a one-day "tumor board style" meeting to decide whether to approve the product.
Notably, the CNPV process may also be used to grant accelerated approval if the product for which the voucher is used meets the applicable requirements. The Accelerated Approval Program allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a surrogate (rather than clinical) endpoint, but requires post-approval studies to confirm the anticipated clinical benefit to remain on the market.
Although admirable in its intent to speed up patient access to meaningful treatments, the brevity of the review process involved may create challenges, at least initially, with coverage of CNPV-approved applications. Historically, insurers (both public and private) have been skeptical of approved products that underwent a faster evaluation or accelerated approval pathway due to concerns about high costs or insufficient safety and efficacy data.
Moreover, because accelerated approval drugs rely on surrogate endpoints and have limited clinical data, payers have historically expressed concerns about the reduction in data required for drugs that are fast tracked. For these reasons, Medicare and private insurers have previously either restricted or delayed coverage for products that have undergone priority or faster review unless or until there was sufficient safety and efficacy data for FDA to grant full approval. State Medicaid programs have also expressed similar concerns but currently lack authority to limit coverage for accelerated approval products.
In light of this information, manufacturers of breakthrough drugs and biologics will want to be aware of the potential implications of expedited approval under the CNPV program, with or without accelerated approval, on their launch trajectory and should carefully analyze market access scenarios of other similarly fast-tracked therapies to help set realistic expectations for payer responses to their product at launch. At least in the CNPV's infancy, it is possible that companies may experience some delay in insurance coverage for the products approved via the shortened CNPV review process, as insurers will likely assess whether they agree with FDA that the data is adequate.
Notwithstanding potential coverage delays for accelerated approval drugs, if the CNPV program merely changes the process and structure of the review but maintains the same rigorous safety and efficacy standards FDA applies under its more traditional review pathways to approve these products (i.e., data shows adequate safety and efficacy), as the CNPV program matures, we could see insurer adoption and coverage of these products more quickly.
The actual patient access impact of the CNPV program is not yet known as FDA is still reviewing prospective candidates for the pilot program. So far, FDA has awarded vouchers to 15 recipients, four of whom negotiated MFN pricing deals with President Trump that also include large investments to expand U.S. manufacturing capacity. We will continue to unpack the potential of the CNPV program and discuss what companies should consider when seeking a CNPV, particularly in light of the many other changes at FDA this year, in a forthcoming Jones Day Talks podcast.
Read the full Innovative Insights: Legal Updates in Life Sciences | Fourth Quarter 2025.
