Following some questions we posed about the efficacy and legality of the Commissioner’s National Priority Voucher (“CNPV”) Program (the “CNPV Program” or “the Program”) in our 2026 Top of Mind Publication, it is again time to ponder the Program’s future, now that its purported champion, former U.S. Food & Drug Administration (“FDA” or the “Agency”) Commissioner, Marty Makary, M.D. (“Dr. Makary”) is out of office. When Dr. Makary resigned earlier this month, he left behind an agency in transition, replete with a portfolio of ambitious reform initiatives that now face an uncertain future. None of those initiatives has attracted more attention — or more controversy — than the CNPV Program. In the wake of concerns over governance of and influence over the CNPV Program, a parallel story is quietly unfolding in the market for statutory Priority Review Vouchers (“PRVs”), where recent blockbuster sales suggest that industry participants may be expressing a preference for the time-tested, congressionally authorized alternative.
A. Dr. Makary’s Departure
Dr. Makary’s resignation was preceded by the departure of Vinay Prasad as CBER head and Chief Medical Officer at the end of April and the transfer of Sara Brenner, M.D., in April, from FDA Principal Deputy Commissioner to the Health and Human Services (“HHS”) Centers for Disease Control and Prevention (“CDC”), and followed by the departure of Tracy Beth Høeg as Center for Drug Evaluation and Research (“CDER”) Acting Director in mid-May. Dr. Makary, Dr. Brenner, Prasad, and Høeg were all closely involved in the CNPV program, with the latter three being former council members. Kyle Diamantas (“Diamantas”), former head of the FDA's food division, has stepped in as acting FDA Commissioner and, as such, now chairs the CNPV council.
A lawyer by trade and former head of the FDA’s food division, Diamantas may not have substantive scientific or medical product review experience, and may not be closely familiar with the CNPV Program’s operations and deliberations to date. Further, as chair, the Commissioner authorizes council members to perform the functions described in the staff manual and leads council discussions — but, importantly, does not vote on approval of CNPV-designated products. Thus, the actual decision-making power for product approvals under the CNPV Program (assuming it remains) will fall to the other council members, which, based on information published to date, consists of the Center Directors,[1] as well as certain senior and ad-hoc advisors deemed necessary by the reviewing team (e.g., subject matter experts). FDA’s Chief Medical and Scientific Officer and Principal Deputy Commissioner are also slated to be on the council, but those roles are currently vacant.
B. The Program Survives – For Now
Despite the leadership upheaval, the CNPV Program appears to be pressing forward. An HHS spokesperson told Fierce Biotech that there will be “no change to the name or direction of the CNPV program at this time” and added that “additional reforms initiated under the previous Commissioner continue to move forward.” That said, certain structural modifications are already underway. According to Mallika Mundkur, a staffer in the Commissioner’s office, the CNPV Program will drop the “C” from its name and meetings with the Program’s review council “will no longer be routinely required for applications.”
However, a critical milestone for the Program’s future is fast approaching. The FDA has scheduled a public hearing for June 4 — thirteen days shy of the Program’s first anniversary — to solicit broader stakeholder input on the Program’s design and direction, including criteria for eligibility, the selection process, review procedures, and other implementation issues. Mundkur wrote, “if we continue the Program in some form following the pilot phase, we expect several aspects of the Program structure to be formally modified [following the public hearing].” The June 4 hearing could prove pivotal. With the Program’s founding champion gone and the Agency in a period of leadership transition, the public record built through that hearing may form the primary basis upon which the next permanent FDA Commissioner decides whether to formalize, reform, or quietly wind down the CNPV initiative.
C. A Boom in the Statutory PRV Market?
While the CNPV Program’s future hangs in the balance, a different kind of priority review voucher market — the one created by Congress under statute, under a clear mandate, and with defined eligibility criteria and transparent processes — appears to be experiencing extraordinary activity. Although some industry experts predicted that the CNPV Program might decrease industry demand for these statutory PRVs, recent sales of statutory PRVs have reached levels well above historical norms[2] — and these transactions may signal where industry confidence actually lies.
Despite the hyper-expedited review times and $0 redemption fee offered by CNPV Program, the statutory PRV program may offer pharmaceutical and biotechnology companies things that the CNPV program has been criticized as lacking — legal certainty and predictability. Indeed, the CNPV Program has been described as “shrouded in secrecy” by Democratic Representative Jake Auchincloss, who sent letters to Dr. Makary in September, November, and February raising these concerns. Further, Reuters reported in January that some leading pharmaceutical companies have hesitated to participate in the Program due to concerns of legal exposure if an expedited review overlooks safety concerns.
Statutory PRVs, by contrast, operate under established law with well-understood rules. The market’s apparent willingness to pay prices near the $200 million mark for these instruments may communicate a market-driven verdict and a broader industry preference for the regulatory certainty that only a congressionally authorized program can provide.
D. Looking Forward
The CNPV Program’s near-term trajectory appears clearer than its long-term fate, but either way, the White House may ultimately have the final say. For example, two government officials told STAT in December that Dr. Makary had cleared all CNPV selections with the White House (despite White House members not being formally listed as CNPV council members), a step that seems to have resulted in at least one selection getting vetoed. Further, President Trump’s executive order on psychedelic treatment invoked the Program by directing FDA to “appropriate psychedelic drugs that have received a Breakthrough Therapy designation and are in accordance with the criteria of the National Priority Voucher Program.” This close association with the White House, of course, does not do much to debunk criticism that the CNPV Program, with its broadly defined eligibility criteria, effectively operates as a loophole for FDA to grant favorable treatment to companies that are friendly with the Trump administration generally.
Put another way — the CNPV Program is unlikely to disappear quietly. It appears too intertwined with the current administration’s drug pricing and policy agenda. But in its current form — criticized as being opaque, legally contested, and championed by a Commissioner who is no longer in office — the CNPV Program is also unlikely to attract the universal industry confidence that a well-functioning expedited review program needs to succeed. The June 4 public hearing might be the first real opportunity to chart a different course. What emerges from that process, and from the selection of a new FDA Commissioner, may determine whether the CNPV Program becomes a durable part of the American drug regulatory landscape or a footnote to the Makary era.
FOOTNOTES
[1] The current Center Directors include: Karim Mikhail (Center for Biologics Evaluation and Research “CBER”)), Michelle Tarver, M.D. (Center for Devices and Radiological Health (“CDRH”)), Michael Davis, M.D. (CDER), and Angelo de Claro, M.D. (Oncology Center of Excellence).
[2] For example, Sun Pharma sold a PRV for $195 million; Ascendis Pharma sold a PRV for $187.5 million; and Rocket Pharmaceuticals sold a PRV for $180 million. These prices represent a considerable premium over historical averages, which were nested around $100 million between 2019 and 2024.