DIA: Former OND head criticizes CNPV program

Philadelphia – Peter Stein, the former head of the US Food and Drug Administration’s Office of New Drugs (OND), criticized the agency’s Commissioner’s National Priority Voucher Program (CNPV) and its one- to two-month review timeline, saying it’s almost “an insult to the FDA reviewers.”

Stein expressed these concerns, along with the merits of the program, at the DIA Global Annual Meeting on Wednesday, arguing that it does not provide sufficient time for thorough evaluations. Stein led OND from 2018 to 2025; he was terminated in April 2025 during the Trump administration’s reduction-in-force effort, which resulted in the separation of some 3,500 FDA employees.

The CNPV program was launched as a pilot under former FDA Commissioner Marty Makary in June 2025, though it is unclear if or how it will move forward.

Under the program, participants gain more frequent interaction with agency officials, a shorter review timeline, and a non-transferrable voucher. Eligible candidates must align with one of the stated US national health priorities, which include products that contribute to a public health crisis response, innovative breakthrough therapies, large unmet medical needs, domestic manufacturing, and affordability. FDA has so far awarded more than 20 vouchers and approved seven products through the program. (RELATED: FDA announces new voucher program for drugs tied to national priorities, Regulatory Focus 17 June 2025)

While FDA has signaled that the program will continue, there is some uncertainty about its future. Lina AlJuburi, head of regulatory affairs at Sanofi, said she isn’t sure whether the program will continue, but that stakeholders should “look forward to build the program; let’s try to fix the program.”

Shortly after the CNPV pilot was announced, legal experts told Focus that there could be challenges to the program, especially given the limited number of vouchers available, and noted that there are still unanswered questions about how the program will work. (RELATED: Questions remain as FDA opens submissions for new priority voucher program, Regulatory Focus 24 July 2025)

Stein’s criticism

When asked to discuss the viability of the CNPV program, Stein, who now helms his own consulting practice, said that he wants to address the agency’s typical drug review process.

“One of the things that has characterized FDA reviews for decades is the quality and the thoroughness of the reviews. I think most of you have gone in and looked at the reviews and you will see that these are not superficial reviews … these are incredibly intense reviews in order to get to the right answer,” he said.

“I would also point out that it takes many, many years, 7 to 12 years to develop products. It takes FDA some months to review it, this is not an unreasonable expectation, but to expect it to be reviewed in two months is an unreasonable expectation,” Stein added.

Stein further noted that the two-month timeline “is almost like an insult to the FDA reviewers,” and pits reviewers, whose job it is to be thorough and get the right answer against the commissioner urging them to speed through the review and “have a high level review by people who do not necessarily know that much about drug development and drug review to make the decision about a drug that is critical to the American people.”

Expedited pathways

Kate Rawson, senior editor at Prevision Policy, said the program borrows elements from the real-time oncology review (RTOR) program and breakthrough therapy designations. She added that “what was new and what it offered was [having] commissioner in the title.”

FDA’s Oncology Center of Excellence announced the RTOR pilot in 2018 to facilitate earlier review of promising new oncology treatments. The program enables sponsors to submit clinical trial data to FDA as it becomes available to support an earlier start to the application review.

Stein pointed out that there is not a one-size-fits-all approach to FDA’s expedited pathways and that while some approaches may work for some purposes, they may not work well for others. “RTOR is an excellent program that is really fit-for-purpose in the oncology space … but in some applications that would not be fit-for-purpose to use,” he said.

Rawson observed that although the agency stated that no more than five candidates would be selected for CNPV, more than 20 have thus far been awarded.

Rawson noted that FDA recently announced changes to the program, including the removal of the "C" from CNPV. She explained that this decision symbolically distances the program in an effort to depoliticize it. Additionally, the CNPV review board has been disbanded and will no longer convene to review and discuss applications.

“If we look ahead, CNPV is RTOR by a different name…. In the absence of CNPV review board and commissioner-level input, [it] looks like RTOR.”

Rawson suggested it is possible that the program might be phased out entirely and said it’s likely that the agency halts the program while it works through the current participants. Another possibility, she said, is that the program could morph into a real-time review program across review divisions.

Rawson said that one aspect of the CNPV program that resonates with drugmakers is its real-time review process; sponsors and FDA were able to leverage electronic health data and monitor trials in real time. “We have already seen AstraZeneca and Merck in these trials. Maybe the next leadership will take this on. [The program] did remove the administrative dead space” between the end of a clinical trial and the submission of the application to FDA.

Lawrence Liberti, director of the D.K. Kim International Center for Regulatory Science at the University of Southern California (USC), said that his research shows that the CNPV program, along with FDA’s other accelerated programs work to expedite reviews for certain treatments. These “[facilitated regulatory pathways] FRPs work, they have an impact on median review times,” he said.