The US Food and Drug Administration needs to make some serious changes to its Commissioner’s National Priority Voucher (CNPV) program, according to several experts and former FDA staffers who testified during a public hearing Thursday.
A panel of FDA leaders from the commissioner’s office, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center for Excellence listened during the hearing but did not respond to any testimony directly.
The CNPV program—announced by way of press release under Commissioner Marty Makary last June, prior to his departure—is meant to speed up FDA review timelines for drugs that meet certain “national priorities.” Those include addressing a health crisis, delivering innovative cures, addressing unmet public health needs, and increasing domestic manufacturing.
But from the get-go, the program has been plagued by confusion. Critics say the listed priorities are overly vague, the application review process is opaque, and, crucially, the program bears marks of political interference that bypasses typical FDA processes.
“The real problem is with the political goals like drug pricing and domestic manufacturing, which are two things that have nothing to do with FDA remit whatsoever,” said Peter Lurie during Thursday’s hearing. Lurie is the president and executive director of the Center for Science in the Public Interest and a former associate commissioner at the FDA. “There’s a taint of political involvement,” he said, adding that the people reviewing the voucher recipients are typically political appointees, and nearly half of the voucher recipients have also struck deals with the White House on drug pricing.
Janet Krommes, a retired rheumatologist who now chairs the FDA task force at the organization Doctors for America, voiced similar concerns. “The ambiguity of the criteria in this context and lack of transparency has given life to rumors about political influences determining winners and losers,” Krommes said.
Twenty-two drug candidates have been awarded CNPVs so far. The vouchers aren’t rubber stamps for their recipients—the FDA rejected Disc Medicine’s bitopertin, an early voucher recipient, from a fast-track approval pathway in February—but they do often align with White House directives, as Lurie pointed out. In April, for instance, the FDA issued three new vouchers to companies developing psychedelics, just days after President Donald J. Trump directed the agency to speed up psychedelics research.
While some speakers did give positive feedback, Krommes and several others called for a pause to the CNPV program until the FDA can solicit feedback and provide robust, publicly available information about the criteria for the vouchers and how they are awarded.
It’s possible that there’s appetite to change the program. The vouchers were initially Makary’s brainchild; another commissioner may feel differently about its implementation. Acting Commissioner Kyle Diamantas reportedly told rare disease nonprofit leaders in a closed-door meeting this week that he would shield FDA reviewers from political interference, according to Endpoints News.
“The program could further incentivize development activities that benefit public health or national security interests, but robust programmatic guidance is critical to achieving these goals,” said Lowell Schiller, a nonresident senior scholar at the University of Southern California and a former principal associate commissioner at the FDA, during the hearing.
