Questions remain as FDA opens submissions for new priority voucher program

The US Food and Drug Administration (FDA) on Tuesday said it will select up to five drugmakers to participate in the Commissioner’s National Priority Voucher (CNPV) pilot in the program’s first year and offered new details about the program’s terms.

Legal experts who spoke to Focus said there could be legal challenges to the program or the selection of participants, especially given the limited number of vouchers available, and noted that there are still unanswered questions about how the program will work.

The program, announced by FDA Commissioner Mary Makary in June, would provide companies that support one of several stated national priorities with a voucher to cut a drug or biologic application review from 10 to 12 months to just one to two months – significantly shorter than the 6-month review under the agency’s existing priority review and priority review voucher programs. (RELATED: FDA announces new voucher program for drugs tied to national priorities, Regulatory Focus 17 June 2025)

The agency also opened a submission form for companies who wish to apply for a voucher, asking firms to select which national priority their drug development program addresses and to provide a brief (less than 350 words) explanation of how the program aligns with that priority.

The update also provides additional details on what constitutes a national priority and introduces affordability as a key criterion for program participation. According to the FDA, selected companies must now meet one of five national priorities: their drugs should address a U.S. public health crisis; provide innovative cures for the public; meet a significant unmet public health need; bring drug development and manufacturing back to the US to enhance the nation’s health interests; or increase affordability. Notably, the fifth priority was not included in the earlier announcement, though Makary said the agency would consider affordability as a factor for the program in appearances on CNBC’s Squawk Box and Bloomberg’s Wall Street Week earlier this month.

FDA said that addressing these issues is a matter of national security, stating that “approximately three-quarters of young Americans would not qualify for military service without a waiver, often on account of obesity and other health conditions,” and noting that “the vast majority of the active pharmaceutical ingredients and drug components in Americans’ everyday medicines are supplied from China.”

Some specific examples of products or programs that would be considered for the program include a universal flu vaccine or “a novel immunotherapy that reprograms the body's immune system to fight multiple diseases.” Other examples are more broad, such as developing products that address rare or chronic diseases where there is unmet need and companies that open new manufacturing sites in the US. Finally, in a nod to the Trump Administration’s effort to limit how much Americans pay for prescription drugs, FDA said that lowering the price of “a drug or drugs consistent with Most Favored Nation pricing” would qualify a company for the program.

To apply for the program, FDA asks that companies submit a statement explaining, in 350 words or less, how their drug development program aligns with one of the eligible national priorities. This description should include information about the targeted disease or condition, the potential impact of the drug, its current stage of development, and any unique aspects of the company’s approach that are particularly relevant to the chosen priority. Additionally, sponsors should mention any issues for which they seek enhanced communication with the FDA.

FDA said that submissions will be evaluated by a senior, multi-disciplinary review committee led by FDA’s Office of the Chief Medical and Scientific Officer. The council will select scientific and medical experts from relevant FDA offices and divisions for a team-based priority review.

Questions and legal challenges

“I think it is possible that it can end up in litigation to the extent that it is not clear why certain applicants were chosen,” Komal Karnik Nigam, a partner with Hogan Lovells, told Focus. She added that, “Given the amount of interest that we have seen for this program it seems possible there may be some kind of litigation in the future in terms of who did and who did not receive one of these vouchers.”

While the CNPVs are non-transferrable, they are likely worth millions of dollars to the companies who receive them. FDA’s other priority review vouchers, which grant a 6-month priority review for the product they are redeemed for, typically sell for more than $100 million.

Nigam noted that the massive number of layoffs at the agency is also prompting questions of whether it will be able to meet its one- to two-month goal in reviewing and making decisions on these applications.

Nigam added that “questions remain on how the commissioner's office will be pulling together the teams that will be included in the application reviews across therapeutic areas, and I don’t think we quite know how these resources will be allocated.”

“It will be very interesting to see what they expect to see before the one-month, or the two-month review clock starts,” Eva Marie Schifini, a senior associate at Hogan Lovells, told Focus.

Mark Tobolowsky, an attorney at Hyman, Phelps & McNamara, told Focus that many questions about the program remain unanswered.

“I think there is a lot that we don’t know still. The material released [Tuesday] had a lot more details. But there’s still a lot more that we don’t know about the selection process and what it means for companies when they actually get the voucher. Right now, the number is limited to five in the first year, and they will make selections on a rolling basis. I expect the competition to be fierce; there’s a lot of excitement in the industry” about the program.

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Questions remain as FDA opens submissions for new priority voucher program

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