FDA’s New Priority Voucher Pilot Program Has Landed: CNPV

After teasing a new rapid review pilot program for the past few weeks, on June 17, 2025, FDA officially announced the Commissioner’s National Priority Voucher (“CNPV”) program to expedite new drug and biologic (but not device or drug-device combination product) reviews.  As described in the press release and accompanying FAQ, the CNPV program is designed to reduce review time to 1-2 months following final drug application submission.  This would be substantially shorter than PDUFA goal timelines (including for priority review as it is currently known), which range from 6 months to 12 months from submission.  The CNPV program will begin in 2025, and FDA will give a limited number of vouchers during a first-year pilot phase.  This pilot phase may be followed by an increase in the number of CNPVs issued.

The press release describes the CNPV process as a “team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices.”  This multidisciplinary team will “pre-review” the submitted information and convene for a “1-day ‘tumor board style’ meeting,” drawing on Commissioner Makary’s experience as a surgical oncologist.  As defined by the National Cancer Institute, tumor board meetings convene multidisciplinary specialists to decide on the best treatment plan for new and complex cancer cases.

FDA plans to issue a limited number of vouchers, without specifying an exact number as of yet.  The vouchers will be issued to “companies aligned with U.S. national priorities.”  According to the press release, which uses slightly different language than the FAQ, the Commissioner will establish these national priorities, which may include, but are not limited to:

• Addressing a health crisis in the U.S.
• Delivering more innovative cures for the American people.
• Addressing unmet public health needs.
• Increasing domestic drug manufacturing as a national security issue.

The Commissioner will use “specific criteria” to award the vouchers, and information will be provided in the near future on how companies can apply for a CNPV and “indicate their alignment with the FDA Commissioner’s criteria to meet national priorities.”  Although many of the initial criteria are broadly applicable, and FDA has not indicated that any single criterion is more important than any other, manufacturing in the U.S. may turn out to be a significant differentiator, particularly while numbers of CNPVs are more limited.

According to the press release, “[v]ouchers 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.”  As suggested by this language and made clear in the FAQ, there will be “product designated” and “product undesignated” CNPV vouchers.  We look forward to additional information about the scope of each type of voucher and, in particular, the criteria and limitations for product undesignated vouchers.  With the available information, a product undesignated voucher would seem to provide the most flexibility and allow companies to pivot from one program to another in the event of unforeseen circumstances, such as ambiguous clinical trial results or problems with a manufacturing facility.

If a company receives a voucher, it must meet certain requirements to qualify for expedited review: an applicant must submit the CMC portion of its application and draft labeling at least 60 days prior to the final application submission and be available for “ongoing communication with prompt responses to FDA inquiries.”  Commissioner Makary stated that this new program “will allow companies to submit the lion’s share of the drug application before a clinical trial is complete.”  While an interesting idea, it is not clear how that timing would ultimately work in practice and whether this refers to more than the CMC section and labeling being submitted 60 days early.

If a company will not yet know if its clinical trial will be successful when it begins submission of the application, it might result in a situation where “the lion’s share” of an application has been submitted to FDA, and a review initiated, for an application that may never be fully submitted due to disappointing results.  The risk of cashing in a voucher in such a situation would be magnified in the case of a product undesignated voucher that could have been better used on a different program.  This assumes that the early submission would be considered a “use” of the voucher, though it is not clear that this is the intent.  Even if a company decides to wait until it has topline results in hand to decide to use a voucher, the potential for a 1-2 month review could be very valuable.  We also note that the agency has given itself some latitude to extend the review window if the data or application components are insufficient or incomplete, if pivotal trial results are ambiguous, or if the review is particularly complex.

The benefits of the CNPV are not limited to FDA review of marketing applications.  The FAQ states that the CNPV can be applied to a product “at any stage in development.”  Such benefits during the IND phase include “enhanced communication” and “prompt responses.”  Among the questions we have are whether the voucher award criteria will differ for a product in development as compared to at the application submission stage and whether a voucher that is used for enhanced communication benefits during development can carry over to the subsequent review of an application.

Although there are some conceptual similarities with other FDA priority review voucher programs, CNPVs are non-transferrable.  However, they remain valid through changes in company ownership, suggesting they are transferrable through mergers and acquisitions.  Vouchers must also be used within two years following receipt or the voucher will expire, so companies should consider their application submission timelines when applying for the CNPV. Time will tell if this leads to some creative corporate mergers and acquisitions.

The CNPV program appears to share some aspects in common with the Real-Time Oncology Review (“RTOR”) program for cancer drugs and the Split Real Time Application Review (“STAR”) pilot program.  While we await additional details for the CNPV program, these programs might provide a reference for some of the details not yet provided.

The RTOR program also involves the earlier submission of certain information, initially top-line efficacy and safety data to determine eligibility, and, if accepted, a maximum of three presubmissions and a final submission.  As described in guidance, the eligibility criteria for RTOR are as follows:

• Clinical evidence from adequate and well-controlled investigation(s) indicates that the drug may demonstrate substantial improvement on a clinically relevant endpoint(s) over available therapies.
• Easily interpreted clinical trial endpoints (e.g., overall survival, response rates), as determined by the review division and the Oncology Center of Excellence.
• No aspect of the submission is likely to require a longer review time (e.g., requirement for new REMS, advisory committee, etc.).

As described in a 2022 FDA analysis, the median time-to-approval from submission for RTOR applications was 3.3 months, ranging from 0.4 months to 5.9.  As an extreme example, FDA approved a supplement for Adcetris (brentuximab vedotin) for a new indication 11 days following application submission.

Similarly, the STAR pilot program “aims to shorten the time from the date of complete submission to the action date” leveraging an earlier submission of much of the application prior to a final submission. However, there is not much public information about the success of the STAR program, perhaps due to low participation (in November 2024, FDA said that there had been no applications in the STAR program to date).

Unsurprisingly, the criteria for the RTOR and STAR program are relatively similar.  They require clear and robust evidence of efficacy without any aspects that would otherwise delay a review.  The RTOR program has shown that FDA is capable of meeting ambitious review time goals under the right circumstances.  However, given that the CNPV program anticipates allowing the “lion’s share” of the application to be submitted before a trial is complete, there may not be efficacy data available at the time of this submission.  This raises questions about the extent to which the use of the CNPV will depend on evidence of efficacy and how that might affect the ability of a review to be completed in the target timeframe.

We applaud FDA in its efforts to set, and hopefully meet, ambitious goals to approve safe and effective drugs in an expedited fashion.  However, at a time when non-expedited FDA approval decisions are delayed due to heavy workloads, we wonder whether such goals can be regularly met and whether they might come at a cost to non-participating programs.  We will be monitoring this program closely to see how it is implemented.