FDA announces new voucher program for drugs tied to national priorities

This year, an unspecified number of drug developers will be eligible to take part in a pilot of the new US Food and Drug Administration (FDA) Commissioner’s National Priority Voucher (CNPV) program, the agency announced on Tuesday.

Recipients of these non-transferrable vouchers are promised a dramatically shorter review of a specific investigational new drug and better access to agency officials, plus products may also be eligible for accelerated approval. The agency also said it will apply a voucher to a specific investigational product or grant an “undesignated voucher” to a company to use at its discretion, so long as its use is consistent with the program.

According to FDA, the CNPV program would shorten the review time after an NDA or BLA submission from 10-12 months to 1-2 months. The program would be separate from and will not replace existing priority review initiatives, which allow review in six months to drugs aimed at treatment of serious conditions.

“This [CNPV] program aims to accelerate the drug review process for companies aligned with US national priorities while maintaining the FDA's rigorous standards for safety, efficacy, and quality,” FDA explained in a press statement.

According to FDA, vouchers will be awarded to companies that align with the program’s stated priorities, including addressing a national health crisis, delivering more innovative cures, addressing unmet public health needs, or increasing domestic drug manufacturing as a national security issue.

As part of the new program, sponsors would submit most application materials early, such as chemistry, manufacturing and controls (CMC) and draft labeling, 60 days before final clinical trial results are available. Vouchers would expire after two years of receipt, though the agency has the option of extending priority review timelines.

“This program will also tackle one of the most common pain points drug developers voiced during a recent listening tour my team took – the difficulty of getting a quick question answered,” FDA Commissioner Martin Makary, MD, said in a video posted on social media platforms. “A 15-minute question can sometimes save drug developers months of guesswork, which is why companies in this new program will get more frequent communications.”

Aside from the shorter timeline, another efficiency offered to selected sponsors is the use of an early, one-day team-based review where a group of multidisciplinary physicians and scientists convene to make a decision about approving an application. Makary, a surgical oncologist, explains this will be like a tumor-board discussion, with review of the latest medical studies. In contrast, a standard review involves submission of information to “numerous FDA offices,” the agency noted in a press statement.

Unanswered questions

There are still many unanswered questions, including the exact timing of its launch and how many applications could be accommodated in the program’s first years. The agency has also faced significant layoffs and staff departures under the Trump Administration’s reduction in force efforts in recent months, which have raised questions about its operational capacity and its ability to meet user fee goals.

“The optimist in me, would like to think that this means that people will be brought back, and that the agency will be brought back to full strength in order to accomplish these kinds of goals,” Eva Temkin, a partner at Arnold & Porter law firm, told Focus. “The pessimist in me is nervous about what it looks like when additional labor-intensive, resource-intensive review processes and decision-making is layered on top of an already strapped FDA.”

Temkin also noted that standard priority review is six months and anything short of that starts to feel “somewhat herculean,” especially since FDA already uses many tools like cross-functional evaluations and multidisciplinary conversations as part of the regular review process.

“So how one gets from six months for a priority review to one to two months for this type of priority review, I think is a really big open question,” Temkin said.

Joseph Ross, MD, professor of public health at Yale University, also has concerns about the capacity of the FDA.

“With the layoffs that the FDA has already experienced, along with resignations and people leaving the agency and retiring early for all the various reasons that happened when the administration took hold, are of course going to make it challenging to meet deadlines and certainly to implement a new program that's even faster, that requires more of people's time on top of their usual work,” Ross told Focus.

Which priorities?

Speaking at the DIA Global Annual Meeting this week, Makary had said that he wanted FDA to be nimbler and that the agency was exploring new pathways and pilot programs. At the time, Makary specified interest in a universal flu vaccine that does not require annual administration, cell and gene therapy, and new treatments for type 1 diabetes. (RELATED Makary says he wants nimbler FDA, calls for new drug pathways and pilots, Regulatory Focus 16 June 2025)

The MAHA Commission Report, released in May, emphasized preventive medicine and overmedicalization of children. In a recent JAMA paper about FDA priorities, Makary and Vinay Prasad, MD, the new director of the Center for Biologics Evaluation and Research, emphasized the toll of chronic diseases and the role of artificial intelligence.

“Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives,” FDA wrote.

The agency says existing priority review and other expedited programs will stay as is.

“The CNPV program will begin in 2025 and contains some of the elements and themes of the priority review programs and PRV programs with a different timeline for the review, product designated and product undesignated subtypes, and prohibition on the sale of the voucher,” FDA explained.

Vouchers could be used at any stage of drug development. The pilot phase will last a year, and the number of CNPVs may rise subsequently.

“The agency will provide information in the near future on how companies seeking to apply can indicate their alignment with the FDA Commissioner’s criteria to meet national priorities,” FDA explained.

FDA announces new voucher program for drugs tied to national priorities

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