Hazards Ahead for FDA’s Drug Review Process

In June 2025 the U.S. Food and Drug Administration (FDA) launched the Commissioner’s National Priority Voucher Program (CNPV), billing the initiative as “accelerated drug review for companies supporting U.S. national interests.” FDA selects specific drug candidates for this program and offers an “ultra-fast” review timeline: 1-2 months, as opposed to the 6-10 months companies could previously expect. 

Public health experts, industry, and agency staff have raised concerns about the CNPV allowing political interference with FDA’s review and approval decisions, as well as the feasibility of assessing a drug’s safety and effectiveness within such a short review timeframe. Amid these concerns, FDA Commissioner Marty Makary has continued to defend and implement the program. Eighteen vouchers have already been awarded under the program, and two drugs approved. 

Faster pathways to market for valuable therapies can benefit both patients and industry. But FDA’s activities under the CNPV program have thrown the drug-review process into a state of escalating change and instability. 

What’s more, given courts’ tendency in recent years to show less deference to agency decisionmaking, the program itself could be vulnerable to legal challenge. Those challenges, if successful, could delay access to new drugs and impact the value and reliability of FDA approval. 

Prior to the launch of the CNPV, drug review timelines were relatively predictable. Under the Prescription Drug User Fee Act (PDUFA), industry sponsors pay user fees that support the cost of drug review, and FDA commits to specific review timelines. These user fees provide over half of FDA’s drug review budget. While concerns remain about whether this funding mechanism gives industry undue influence, PDUFA has created shorter and more predictable review timelines. Under PDUFA, the date of FDA’s approval decision is generally tied to the date on which the FDA accepts the application for review. FDA assigns each application a PDUFA goal date: either 10 months (standard review) or six months (priority review) from the date of acceptance. 

FDA grants priority review to therapies targeting a serious disease or condition that may offer improvement over existing alternatives. Several additional programs exist to facilitate review of certain drugs for serious conditions: fast track designation, breakthrough therapy designation, and accelerated approval. Within these programs as well, goal dates are fairly predictable, with most products eligible for priority review. 

Within this established system, the CNPV’s shortened review time is extremely valuable because it allows companies to start selling their product much earlier. Commissioner Makary has estimated the value of CNP vouchers at upwards of $100 million. 

How are these vouchers awarded? FDA says that five “national health priorities” guide the selection process: 

1. Public health crises
2. Innovative therapies
3. Unmet medical needs
4. Onshoring of manufacturing
5. Affordability

These priorities are not well defined, and some may be outside FDA’s remit. The voucher selection process itself remains opaque. According to internal guidance posted months after implementation, an official within the Commissioner’s Office documents each voucher selection; but that documentation remains internal. At some point after the initiation of the program, FDA began awarding vouchers proactively, without a company having applied. But it’s not known which products have been proactively selected or what the role of political leadership has been in the selection process.

FDA leadership are dangling a very valuable benefit before drug developers without offering much clarity up front about which drugs might be selected. It may be difficult for FDA to later justify its selection process or defend the quality of the 1-2 month review.

Will the CNPV continue to exist? As things currently stand, the program has no specific statutory authorization and could be phased out under a subsequent administration. Congress will likely consider FDA-related legislation as part of the upcoming PDUFA VIII reauthorization, which is expected to pass by September 30, 2027; it’s unclear whether the CNPV will be included. It’s also possible that CNPV-like performance goals could find their way into the PDUFA VIII commitment letter that is negotiated between FDA and industry, though summaries of negotiations to date do not suggest a focus on the program.

Whatever the CNPV’s fate post-2027, the program has opened FDA to legal challenges that could have wide-ranging effects on the drug review process. 

A company could claim that FDA is treating similarly-situated applicants differently — for example, if its competitor is awarded a voucher while its own application is declined, or if FDA resources were diverted from its own application to a competitor’s. Companies could also claim that the CNPV is departing from previous agency practice without explanation, or that the CNPV selection process is based on criteria that Congress did not intend.

In implementing the CNPV, FDA has relied on a decades-old statutory provision that requires “substantial evidence” of a drug’s effectiveness as a condition of approval. The statute provides little detail on how the approval process should actually work, and courts have previously deferred to FDA’s interpretation, allowing the agency to establish its own detailed criteria and processes for drug review and approval. 

Following the Supreme Court’s recent ruling in Loper Bright, however, a court might not afford FDA the same deference. Faced with a challenge to FDA’s implementation of the CNPV, a court could apply its own “independent judgment” to determine the “best” reading of the substantial evidence requirement, and rule based on its own views as to whether FDA is approving drugs in accordance with the law. 

Another litigation angle: “failure to warn” challenges. If a patient is injured by a product approved under the CNPV, he could sue the manufacturer claiming that the risk of that injury was inadequately reviewed and described in the labeling. If successful, these claims might force the manufacturer to add additional warnings or other restrictions to the product label. Such challenges could further damage the credibility of the CNPV and perhaps — since FDA claims to be applying the same evidentiary standards to CNPV products as to all drug reviews — of FDA drug approvals more generally. 

By initiating this highly discretionary CNPV reprioritization scheme, current FDA leadership have destabilized the drug review process and increased the chances of successful legal challenge. Litigation challenging FDA determinations under the CNPV could delay patient access to new therapies, undermine the validity and reliability of FDA drug approvals, and impact investment in the development of new drugs.