While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Review voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
The FDA’s Commissioner’s National Priority Review Voucher pilot program, unveiled last year, has left many stakeholders with more questions than answers. Now, some experts are recommending a pause for reevaluation—or cancellation altogether.
A pause would “force program designers and implementers to be more articulate . . . making everybody feel more comfortable with the program itself,” Michael Abrams, managing partner at healthcare consulting firm Numerof & Associates, told BioSpace. He suggested the program was put into place quickly to show results before President Donald Trump’s second term ends in January 2029.
Peter Pitts, a former associate commissioner at the FDA and president and co-founder of the Center for Medicine in the Public Interest, supports canning the program altogether. “It can cease to exist,” he said. “It is entirely redundant relative to the pathways that already exist, and I don’t think that the opinions of a small group of executives inside the FDA should be able to trump the sophisticated decision-making process the centers already have in place.”
Launched by former FDA Commissioner Marty Makary—who departed the agency under pressure in May—the CNPV program kicked off last June “to explore streamlining review processes for a subset of products” associated with U.S. national priorities that include unmet medical needs and public health considerations, according to officials who spoke at a public session earlier this month.
While drawing applause for its intent, the program has also become contentious. Some of the concern stems from the larger picture at the FDA, particularly the rapid leadership turnover at the agency, Abrams said.
Seven drugs so far have won FDA approval via the expedited pathway, including Eli Lilly’s GLP-1 pill Foundayo and a hearing loss gene therapy from Regeneron. The agency has distributed 22 vouchers overall for therapies addressing cancer, rare disease, mental health and other indications considered priorities for U.S. health security.
Biopharma companies have been eager to support another avenue to expedite drugs to market. But at the June 4 meeting, representatives from industry giants like Johnson & Johnson and Merck, as well as smaller biotechs, physician groups and patient advocates, urged the FDA to introduce more transparency around candidate selection and the review process. This has been a common refrain around the CNPV program, with regulatory experts telling BioSpace in March that this aspect of the pathway, in particular, is still unclear.
The program is also part of a larger plan to reshape the FDA, Abrams said.
“There’s been a lot of handwringing during the course of this administration over the changes that have been made, but what they’re trying to do here is broader and more ambitious than the FDA’s goals have been in the past,” he said. “This is about reshaping the industry, not just ensuring safety and timely approval . . . and that makes a lot of people uncomfortable.”
This month’s session was the first opportunity for public comment regarding the CNPV program since the pilot launched a year ago.
A series of controversial events have marred the program, including the surprise rejection of Disc Medicines’ protoporphyria drug bitopertin and Sanofi’s reported request to revoke its own voucher for diabetes drug Tzield after interference from former acting Center for Drug Evaluation and Research director (CDER) director Tracy Beth Høeg. That interference was officially confirmed this week in a memo by current acting CDER director Michael Davis. Some experts are calling for a reevaluation of the young program to resolve lingering uncertainty and address fundamental issues around how it fits into the FDA’s existing infrastructure.
Intent vs. implementation
Stakeholders across the board are widely in support of speeding drug review times, and drugmakers in particular see the upside in reaching the market more quickly, according to Graig Suvannavejh, managing director and senior biotech and biopharma analyst at Mizuho Securities.
“I don’t think I’ve heard of any company that’s been against the program per se, despite finding issue with how drugs are selected,” he told BioSpace.
But while biopharma companies would benefit from faster review times, they need to consider the long game, Suvannavejh added.
“Bigger picture, I think companies would be in favor of a pause to make sure we understand what’s happening at the FDA, especially in terms of transparency, which is paramount,” he said. “We need to dot the i’s and cross the t’s, making sure we have a well-thought-out program from a regulatory, industry and legal perspective.”
Drugmakers have stayed relatively quiet in the public arena regarding the initiative’s future. Most did not respond to a request for comment.
Italian biotech Dompé Farmaceutici, which holds a voucher for the first potential treatment for a kind of vision loss associated with obesity, cardiovascular disease and aging, supports the program. While Dompé did not respond to BioSpace’s specific questions regarding a potential pause, a spokesperson said in an email that the selection of the company’s drug will help bring it to patients sooner.
The program has also elicited support from those such as Abrams who want to see the FDA address wider issues affecting U.S. health security, giving the agency authority to make decisions with more far-reaching policy impact.
“The intent is to reshape our pharmaceutical sector to operate on a faster timeline, to focus on those therapeutic areas that are most urgent nationally,” Abrams said. “You have to see the CNPV program in the broader context of the administration’s policies—on pricing, for example, or on the use of tariffs and real-time clinical trial monitoring.”
Straight from the top
The FDA already has several programs in place to speed drug reviews, all with specific use cases determined by offices like the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). Pathways such as Fast Track, Breakthrough Therapy, accelerated approval and priority review have allowed the agency to approve drugs more quickly than the standard 10 to 12 months.
The CNPV has promised an unprecedented 1- to 2-month turnaround, but that comes with new territory for the agency in terms of execution.
Adding a new expedited route at the discretion of the commissioner is a “bad idea,” Pitts said.
“The choice of programs to expedite should not be at the level of the commissioner’s office. It should be within the review centers,” he told BioSpace, arguing that medical experts and directors of specialized organizations within the agency should make those decisions.
Notably, the FDA published a staff manual guide in January elucidating the decision-makers on the CNPV review council—which include the FDA’s chief medical and scientific officer and the directors of CBER and CDER—and their roles. While the commissioner will serve as council chair and “will moderate discussions relating to voucher selection,” this individual will not vote on discussions related to approvability, according to the document.
But Pitts voiced objections. “The commissioner is a political appointee . . . and any direct interference in the review process by a political appointee leads to bad places, regardless of the intentions of the commissioner.”
So far, Pitts said he has not witnessed what he considers direct evidence of politicization of the CNPV process, but he warned of fertile ground for even unintended coercion in the future.
“I’m less concerned about a commissioner saying, ‘This is of interest to me. Put it to the top of the queue,’” Pitts said. “I would be more concerned about influence from outside the agency.”
Acting CDER Director Davis has now published a policy memo giving credience to Pitts’ concerns—at least when it comes to the division directors.
In the memo, published by BioCentury on Wednesday, Davis shares that the CNPV review council was in favor of giving the green light to Sanofi’s Tzield for patients eight through 17 with stage 3 type 1 diabetes but that Høeg “voiced objection” to its approval at each of four review meetings.
"[Høeg] disagreed with the review team’s view that the product’s benefits outweighed its risks,” Davis wrote. Høeg requested an advisory committee meeting be held to discuss the application—a position Davis disagreed with. Sanofi was informed of a planned adcomm, according to the memo.
Tzield was granted a priority voucher in October 2025. In May, Sanofi reportedly requested Tzield be removed from the CNPV program after a high-level disagreement over whether to approve the drug. Tzield ultimately won approval in this indication last week.
Furthermore, with the FDA already stretched thin due to broad workforce cuts last year, a commissioner’s own priorities could supersede those of the agency as a whole, Pitts noted.
“The criteria is that a very small coterie of FDA officials decides that a given development program is more important than every other development program currently being reviewed by the appropriate center and division,” Pitts said. “And I think, considering the recent experience of the people filling those seats, it is a bad idea to take those decisions outside of the centers of jurisdiction.”
