FDA seeks input into 'opaque' priority voucher scheme
The FDA has scheduled a public meeting to discuss its Commissioner's National Priority Voucher (CNPV) programme, amid concerns over its transparency and legality.
According to the regulator, the meeting aims to get feedback on the eligibility criteria for various elements of the programme, the voucher selection processes, sponsor responsibilities, pre-submission requirements, FDA review procedures, and the role of the CNPV review council.
Introduced in June 2025, the CNPV route promises to deliver regulatory decisions on marketing applications in a matter of weeks, rather than the usual several months, and has already delivered four regulatory approvals, most recently for a high-dose version of Novo Nordisk's weight-loss drug Wegovy (semaglutide), and one rejection.
According to the FDA, the intention is to bring important new therapies to patients more quickly and plug gaps in the domestic supply of essential medicines.
However, critics claim that the selection process is opaque, the scheme lacks statutory backing, that political appointees rather than career regulators are carrying out the reviews, and that recipients may be selected for political reasons – for example, as a quid pro quo for pricing deals or investments in domestic manufacturing.
Among those with concerns about the CNPV approach is Democratic representative Jake Auchincloss, who sits on the House subcommittee on health, who raised his concerns in an interview with US News last month and has since reiterated many of the points in a Q&A on his official website.
"The question is: Why would the commissioner dole out a higher likelihood of a yes? It really is the commissioner's to dole out, because this review board is political people who report to him. They're not career scientists," according to Auchincloss.
"The reason he's doling out an increased probability of a yes is that it's tied to pricing. He is trying to score wins for the White House, and the way he's doing that is by doling out approval cards," he added. "The problem with that is that it's illegal. The FDA can't do that. The FDA has to evaluate drugs based on safety and efficacy – not on any consideration of price."
Auchincloss is also concerned that letters sent to FDA Commissioner Marty Makary last year outlining concerns about the programme, which he says is " short-circuiting scientific review," have gone unanswered. He has called for Makary to sit in front of the House health subcommittee and answer questions on his activities at the FDA.
Makary said the meeting will help guide the CNPV programme "after a very successful first year," claiming that it is "a game changer for patients waiting for life-changing therapies."
Photo by Sasun Bughdaryan on Unsplash
