A Tale of Three Vouchers

The Food and Drug Administration (FDA) has said it intends to provide new “Commissioner’s National Priority Vouchers” (CNPV) to certain drug applicants that will be able to claim a one- to two-month drug review—much shorter than the typical eight- to 12-month review—when the drug, or drug sponsor, meets a priority of the commissioner of the Food and Drug Administration. In addition, Congress has established three priority review voucher (PRV) programs to incentivize the development of certain drugs, two of which have expired and require reauthorization by Congress. We now examine and compare the commissioner’s voucher program and the three statutory PRV programs.

Background on drug review performance goals

Under the Prescription Drug User Fee Act (PDUFA) goal letter, FDA commits to reviewing standard drug and biologic applications within 10 months and priority applications within six months at least 90% of the time. FDA designates a product for priority review if the product is intended to treat, prevent or diagnose a serious disease or condition and FDA determines the product has the potential to deliver a significant improvement in safety or effectiveness in such treatment, prevention or diagnosis. These six- and 10-month timelines begin after the FDA formally accepts the application, 60 days after it is submitted. Thus, actual timelines for approval decisions typically run eight- to 12 months after applications are submitted.

FDA typically exceeds its goals to review 90% of applications within the designated timelines, though results are not guaranteed. Occasionally, FDA reviews products more quickly than PDUFA goals when there is an especially high unmet need and when FDA offices and review divisions are able and inclined to proceed more quickly in the interest of public health. On these occasions, FDA has been able to shave one to three months off a review period but has not reliably cut down to the one- to two-month review period promised by the CNPV program.

The statutory PRV programs

Congress has established three statutory PRV programs, one for neglected tropical diseases in 2007, one for rare pediatric diseases in 2012, and one for medical countermeasures to chemical, biological, radiological or nuclear attacks in 2016. Each establishes a clear deliverable—FDA approval of a never-before approved drug in a disease area for which there are insufficient market incentives in the United States—in exchange for which the drug’s sponsor receives a voucher, which provides the ability to claim a single priority, six-month review for a drug of the sponsor’s choosing, to be used on drugs that normally would not qualify for a priority review. This voucher is transferable to another drug sponsor, and it can be used any time after it is awarded.

For small drug companies, obtaining approval of a qualifying drug allows a comparatively large near-term payoff for the drug by selling the PRV to another sponsor: vouchers have recently sold for about $100 million. For larger companies, a PRV represents the opportunity potentially to accelerate a new product (or a new indication for an already approved product) to market by four months (“potentially” because, for example, the priority review may end with a Complete Response Letter (CRL), as happened at least once, or be extended because the sponsor files a major amendment to the application). FDA has awarded PRVs under each of these programs, though the rare pediatric disease PRV program has been the most successful, resulting in the approval of more than 55 products for rare pediatric diseases since the program was authorized in 2012.

This structure is critical to how these PRV programs are intended to work: they add return on investment for FDA approval of one of the specified drugs: $100 million or so for a company that sells a voucher and at least that much (likely much more) for a company that gains or purchases one and redeems it.

Whereas Congress permanently authorized the neglected tropical disease PRV program, it did not do the same for the other two programs. FDA’s authority to designate new drugs as eligible for the pediatric rare disease PRV expired on Dec. 20, 2024. The medical countermeasure PRV program expired on Sept. 30, 2023.

There have been efforts to revive both. On Sept. 17, 2025, the House Energy and Commerce Committee unanimously approved the Give Kids a Chance Act, H.R. 1262, which includes a reauthorization of the rare pediatric disease PRV program through Sept. 30, 2029. As the bill has 288 bipartisan cosponsors, the bill would likely be a successful candidate for consideration in the House either as a stand-alone vote or included in a bipartisan package of legislation. The Senate has not yet taken action to reauthorize the PRV, though bipartisan legislation to do so has been introduced. In 2023, in its proposed reauthorization of the Pandemic and All-Hazards Preparedness Act, the Senate HELP Committee approved an extension of the medical countermeasure PRV program through Sept. 30, 2028, but that bill was not enacted.

The FDA Commissioner’s Voucher Program

On July 22, 2025, the FDA began accepting applications for the “Commissioner’s National Priority Voucher” (CNPV) for drug reviews, which Commissioner of Food and Drugs Marty Makary had announced in June to provide application review time of a month or two after the application submission.

The FDA intends to make no more than five CNPVs available in the first year, and they must be used by recipients within two years. Unlike congressionally authorized PRV programs, CNPVs will not be transferable to other companies. To facilitate a one- to two-month review, certain portions of the application, such as labeling and manufacturing data, are to be submitted early, to be reviewed before reviewing the final clinical trial data. To be awarded a CNPV, the application must be for a product that addresses one or more of the following “national health priorities”: addressing a health crisis in the United States, delivering more innovative cures for the American people; addressing a large unmet medical need; onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency; and increasing affordability, including by agreeing to price the drug under “Most-Favored Nation” drug pricing. Applications may be submitted through the FDA’s website.

Yet, questions remain.

Is a one- to two-month review possible? As noted above, the agency has reviewed applications within a couple of months on rare occasions. The quick review successes appear to be exceptional circumstances; when the stars aligned, the agency sprinted to make public health advancement possible, the application didn’t raise difficult review questions and the data showed strong benefit-risk. It seems less plausible that the stars will so align on an application that the sponsor may choose for commercial value, when the application may raise difficult review questions or risk-benefit decisions are far closer (sponsors may mitigate this risk by careful choice of the application for which they redeem CNPVs).

Does FDA have the resources to execute on CNPVs? There will likely need to be reallocation of review resources from FDA’s drug centers to review CNPV applications in one or two months. Doing so will necessarily subtract from the review resources for other application work, which may delay other work. Still, if resources are managed very carefully, the impact may be marginal.

CDER and CBER currently struggle to meet certain PDUFA goals, such as those related to meetings with sponsors, where FDA faces challenges scheduling these meetings, producing summaries of meeting outcomes and responding to follow-up questions within PDUFA time limits. It seems likely these struggles will not be remedied, and may be aggravated, by the resource needs of the CNPV program.

It’s also worth noting that the statutorily authorized PRV programs require payment of an extra user fee on top of any other application fee to provide for the additional resources needed to conduct a priority review. No similar fee would exist for the CNPV program.

How will the early submission of drug labeling work? It is impossible to write and review a drug label without a thorough understanding of all the clinical trial data. What is the drug’s indication? What are its limitations on use or its contraindications? What are the drug’s side effects? What did each clinical trial show? There is a reason FDA typically works on the labeling after it has reached a decision to approve a drug, not before. Labeling review before the final trial results review is putting the cart before the horse.

Will the CNPV be an incentive for drug development? The statutory PRV programs are clearly designed to provide an incentive for development of certain drugs identified by Congress as priorities. That is, a drug sponsor can know the criteria to obtain a PRV and potential value of a PRV when making the initial decision to invest in a drug’s development and thereafter as the drug is periodically reassessed against both developing data about the product and changing commercial circumstances (such as the failure of, or unexpectedly strong data from, a competitor drug). In this way, the availability of a PRV can both make the initial case for, as well as sustain, drug development.

By contrast, at least for the first several years and because the award of a CNPV is entirely discretionary and based on largely undefined criteria, it is hard to understand the CNPV as incentivizing anything. It will reward drug sponsors that happen to be in a position to have developed a drug that meets one of the FDA commissioner’s national priorities, but one cannot argue that the CNPV incentivized those drug development decisions, including decisions about where the drug will be manufactured, because they are made early in a process that takes many years to complete.

Additionally, the lack of transferability and the requirement to use the CNPV within two years limits the appeal of the voucher to only those companies with multiple products that are ready for FDA review in a short period. Because of these limitations, small biotech companies are less likely to benefit from a CNPV.

It is also difficult to imagine a sponsor choosing to price a drug lower in the United States because of a CNPV, as it is hard to imagine the resultant lost revenues being offset by the gain in revenues of the earlier approval of some other drug.

Next steps

We will monitor the outcomes of the CNPV program as well as steps toward reauthoring the rare pediatric PRV program and provide updates as needed.

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THIS DOCUMENT IS INTENDED TO PROVIDE YOU WITH GENERAL INFORMATION REGARDING NEW MEDICAL DRUG VOUCHER PROGRAMS. THE CONTENTS OF THIS DOCUMENT ARE NOT INTENDED TO PROVIDE SPECIFIC LEGAL ADVICE. IF YOU HAVE ANY QUESTIONS ABOUT THE CONTENTS OF THIS DOCUMENT OR IF YOU NEED LEGAL ADVICE AS TO AN ISSUE, PLEASE CONTACT THE ATTORNEYS LISTED OR YOUR REGULAR BROWNSTEIN HYATT FARBER SCHRECK, LLP ATTORNEY. THIS COMMUNICATION MAY BE CONSIDERED ADVERTISING IN SOME JURISDICTIONS.