Executive Summary 

• The Commissioner’s National Priority Voucher Program (CNPV), initiated by Food and Drug Administration Commissioner Marty Makary, has dramatically shifted the previously tightly controlled and regulated drug and biologic approval process. 
• Announced in June 2025, the program offers selected sponsors a drastic reduction in review time: Instead of the standard 10–12-month clock for a new drug application or efficacy supplement, CNPV products are promised decisions in roughly 1–2 months, backed by a high-touch, multidisciplinary review process. 
• Policy leaders and experts have raised concerns regarding transparency, CNPV’s legal basis, and its potential to function as a “lucrative gift” to favored companies, while warning that ultra-compressed review windows risk turning drug regulation into a series of one-off deals; the tradeoff of faster access to high-impact treatments and the procedural and governance concerns raised by a largely discretionary new pathway should both remain at the forefront of impact analysis. 

Introduction 

The Commissioner’s National Priority Voucher (CNPV) pilot is one of the Food and Drug Administration’s (FDA) newest – and most aggressive – tools for speeding drug reviews in the name of U.S. national interests. Announced in June 2025, the program offers selected sponsors a drastic cut in review time: Instead of the standard 10–12-month clock for a new drug application or efficacy supplement, CNPV products are promised decisions in roughly 1–2 months, backed by a high-touch, multidisciplinary review process. 

The CNPV program is framed as a response to two intertwined threats: the deteriorating health of the U.S. population and the fragility of the drug supply and availability chain. FDA explicitly points to the fact that roughly three-quarters of young Americans would not qualify for military service without a waiver – often due to obesity and other chronic conditions – as well as the heavy reliance on China for active pharmaceutical ingredients in everyday medicines. These concerns are cast not just as public health problems but as national security vulnerabilities that justify extraordinary regulatory flexibility.

To qualify for a CNPV, companies must show that a specific product aligns with at least one of five program priorities: addressing a U.S. public-health crisis; delivering “innovative cures” with transformative impact; tackling a large, unmet medical need; onshoring development or manufacturing to strengthen U.S. supply-chain resilience; or increasing affordability, whether through lower prices or reduced downstream utilization. Sponsors submit a short statement of interest, FDA review divisions nominate candidates, and a senior committee led by the Office of the Chief Medical and Scientific Officer selects participants. The voucher itself promises accelerated timelines, enhanced communication, rolling review, and the possibility of also receiving designations under existing expedited review authorities.

Implementation has moved quickly. On October 16, 2025, FDA named the first nine voucher recipients across infertility, Type 1 diabetes, vaping addiction, rare blindness, porphyria, pancreatic cancer, and genetic deafness. There are also two domestically manufactured generics chosen explicitly for U.S. manufacturing resilience. A second batch on November 6 added six more therapies – spanning HER2-mutated lung cancer, pediatric drug-resistant tuberculosis, rectal cancer, sickle cell disease, and two obesity drugs paired with pricing commitments for Medicare and Medicaid – bringing the total to 15.

The program has already become a political flashpoint. Congressional leaders, FDA staff, and outside experts have raised concerns regarding transparency, CNPV’s legal basis, and its potential to function as a “lucrative gift” to favored companies, while other experts warn that ultra-compressed review windows risk turning drug regulation into a series of one-off deals. As a result, any discussion of CNPV must grapple with both sides of the ledger: its promise of faster access to high-impact treatments, and the procedural and governance concerns raised by an ultra-fast, largely discretionary new pathway. 

CNPV Pilot Recipients 

The FDA commissioner will establish national health priorities for the program to address, such as (but not technically limited to): addressing a health crisis in the United States, bringing potential innovative therapies to the American people, addressing a large unmet medical need, and increasing affordability. Companies are then either invited to apply for a CNPV in conjunction with a new drug approval application or are selected from an already submitted new drug approval application.

Taken together, the initial 15 CNPV recipients run the gamut of the program’s stated priorities: lowering prices for strategically chosen products (IVF and GLP-1s); shoring up domestic capacity for essential generics (ketamine, Augmentin XR); advancing high-impact treatments for cancer, diabetes, obesity, and infectious disease; and accelerating a few showcase gene and rare-disease therapies.  

Affordability and competition 

Perceived affordability has been the centerpiece of many decisions made by the FDA commissioner. In the CNPV, the clearest affordability plays are: 

• Pergoveris (Merck KGaA, infertility): Framed by the Department of Health and Human Services and the White House as a competitor to a “much more expensive option” for IVF, aimed at lowering fertility treatment costs and squarely fitting the “increasing affordability” priority. 
• Wegovy and orforglipron (Novo Nordisk/Eli Lilly, obesity): These vouchers are tied to pricing agreements under which both companies commit to lower prices for Medicare and Medicaid, putting them at the intersection of the obesity epidemic and formal affordability concessions. 
• DB-OTO (Regeneron, genetic deafness): FDA officials have suggested the sponsor may offer DB-OTO at an “extremely low price or for free,” making it a marquee affordability example as well as a scientific outlier. 

Other products – such as cytisinicline (a potentially lower-cost vaping cessation aid) or Casgevy (with potential to offset lifetime sickle-cell costs) – may contribute to affordability, but public rationale has emphasized disease burden over explicit price commitments. 

Domestic manufacturing and supply-chain resiliency 

Program materials repeatedly highlight onshoring of critical drugs as a national security priority. Two awards are explicitly framed this way: 

• Ketamine (Phlow Corporation, anesthetic): Described as onshoring a crucial general anesthesia to address persistent shortages of sterile injectables and reliance on foreign active pharmaceutical ingredient sources. 
• Augmentin XR (USAntibiotics, antibiotic): Selected “specifically for U.S. manufacturing resilience,” emphasizing supply-chain security rather than novelty or unmet need. 

Pediatric bedaquiline for drug-resistant tuberculosis (TB) may also reflect preparedness and supply concerns given the strategic importance of anti-TB therapies, though FDA’s public explanations center on infectious disease burden. 

Large unmet medical needs and major disease burdens 

Many voucher products fall into the “large unmet need” bucket. These include: 

• Teplizumab (Sanofi, Type 1 diabetes): Delays onset of a lifelong autoimmune disease with high downstream costs, making it both a chronic disease and cost-avoidance play. 
• RMC-6236/daraxonrasib and zongertinib (Revolution Medicines/Boehringer, pancreatic/lung cancer): Target aggressive cancers with limited options – KRAS-driven pancreatic and lung cancers for RMC-6236, HER2-mutated lung cancer for zongertinib – aligning with the program’s focus on transformative oncology. 
• Dostarlimab (GSK, rectal cancer): Enables chemo-sparing, organ-preserving approaches in mismatch-repair-deficient rectal cancer, reducing the need for traumatic surgery and radiation. 
• Bedaquiline (J&J, pediatric drug-resistant TB): A child-tailored formulation for drug-resistant TB, addressing a high-stakes infectious disease gap. 
• Cytisinicline (Achieve Life Sciences, vaping addiction): Directly targets nicotine vaping addiction in youth, which FDA treats as a national-priority public-health issue. 

Obesity therapies Wegovy and orforglipron also fit here, given FDA’s framing of obesity as a threat to readiness and national health, even though their public rationale is dominated by messages about pricing. 

Transformative gene/cell therapies and rare disabling conditions 

Another thread in CNPV selection is “innovative cures” that go well beyond the threshold for breakthrough designation. Among the initial recipients, these include: 

• DB-OTO (Regeneron, genetic deafness): A first-in-class gene therapy for a rare genetic form of deafness, emblematic of one-time, potentially curative interventions that dramatically improve quality of life. 
• Cenegermin-bkbj (Dompe, blindness): Treats neurotrophic keratitis and is described as addressing blindness by preventing severe corneal damage and vision loss in an undertreated rare disease. 
• Bitopertin (Disc Medicine, porphyria): Targets erythropoietic protoporphyria, a rare porphyria marked by extreme photosensitivity and few options, firmly situating it in the “rare disease or unmet need” lane. 
• Casgevy (Vertex, sickle cell disease): A CRISPR-based gene-editing therapy for sickle cell disease, highlighted as a flagship “innovative cure” given its scientific novelty and the massive lifetime burden of disease, especially in Black patient populations. 

Differentiation Between CNPV and Other Expedited Review Pathways 

The CNPV pilot sits on top of FDA’s existing expedited review toolbox rather than replacing it, but it differs from the classic programs in why it exists, how products are chosen, and what it does. 

Traditional expedited pathways – Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review – are all built around the same core idea: a drug for a serious or life-threatening condition that addresses an unmet medical need or offers a meaningful improvement in outcomes gets extra regulatory attention. The authority for these programs is written into statute and guidance, and the selection criteria are almost entirely clinical. In other words, the trigger is the disease and the potential benefit for patients with that disease. 

CNPV, by contrast, is framed around “national priorities” more than disease severity alone. FDA’s five program pillars are much broader and outside of the usual metrics used to adjudicate drug approvals. That’s why something like domestic production of ketamine or Augmentin XR can qualify: The science is not dramatically different from existing products, but the on-shoring and supply-security angle elevates it into the CNPV conversation. Similarly, explicit pricing commitments on GLP-1s or fertility drugs can be central to the rationale in a way that would be irrelevant for Priority Review or Breakthrough. 

The underlying program mechanics are also different. Priority Review cuts the Prescription Drug User Fee Agreement (PDUFA) goal date from about 10 months to about six. Priority Review Vouchers, earned by bringing a rare pediatric or tropical disease drug to market, can be sold to another company and used to obtain that six-month clock for a different application, in exchange for an extra user fee. Accelerated Approval changes what kind of evidence is acceptable for approval by leaning on surrogate endpoints, with post-market obligations. Fast Track and Breakthrough mostly change how the development program interacts with FDA (more meetings, rolling review, early engagement). FDA has recently worked to change these programs as well, but again, the CNPV program sits outside of these efforts rather than as a part of them. 

CNPV is more radical on timing and more constrained on who can use it. It aims for a 30–60-day review window, using an intensive, “all-hands” review model with early chemistry, manufacturing, and controls (CMC) assessment and labeling work and continuous communication. The voucher is not transferrable, must be used within a short period, and is tied to the sponsor, not a specific asset that can be sold. FDA has been explicit that CNPV can layer on top of other expedited tools rather than replacing them, but in practice it is a commissioner-driven, discretionary overlay for a very small number of products that align with a broader agenda on health crises, supply chains, and pricing – whereas the legacy programs are disease-centric, codified, and broadly available to any drug that meets its clinical criteria. 

Potential Issues With the CNPV Program 

While the CNPV program creates an ambitious framework to work through some common criticism of the FDA’s review process, that ambition comes with a long list of potential issues. These concerns span legal authority, operational capacity, scientific rigor, and basic questions of fairness and governance. 

Legal and governance risks 

Unlike Priority Review, Accelerated Approval, or the statutory Priority Review Voucher programs, CNPV was not explicitly created by Congress. It rests instead on FDA’s more general authorities under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to organize its work and pilot new programs. Lawmakers have already questioned whether this kind of non-transferable, ultra-fast review voucher – tied to opaque “national interests” criteria – exceeds what Congress intended when it set out FDA’s expedited pathways. Critiques include using CNPV as a potentially “lucrative gift” for politically favored companies and highlighting the lack of explicit statutory authorization or notice-and-comment rulemaking. 

Legal commentators have similarly noted that the program could be vulnerable if a disappointed sponsor or public-interest group argues that FDA has effectively created a new class of review deadlines and incentives without going through the Administrative Procedure Act, or that the selection criteria are arbitrary and capricious. Because user-fee performance goals and established review clocks are deeply intertwined with PDUFA commitments, CNPV also raises awkward questions about whether FDA can re-prioritize a handful of politically salient products without undermining its obligations to the rest of its docket. 

Operational and logistical strain 

Delivering a full new drug application or biologic licensure application decision in 1–2 months demands a level of resource concentration that is unprecedented outside emergency situations such as the development and approval of COVID-19 vaccines. FDA’s own materials describe a “team-based,” tumor-board-style review model, with early CMC submissions and intensive, continuous communication. Analyses from law firms and consultants warn that, in practice, this likely requires diverting experienced reviewers from other programs and creating de facto “tiger teams” for CNPV dossiers. 

That raises two linked issues. First, non-CNPV applications – often for equally serious conditions – may face slower, more fragmented reviews as staff are pulled into voucher work. Second, there is a real risk of burnout and turnover if already stretched review divisions are repeatedly asked to hit 30–60-day targets. Commentators have warned that the pilot could become a “resource drain” unless FDA builds new capacity or caps the number of vouchers well below what political actors might like.  

Scientific, safety, and perception concerns 

A New England Journal of Medicine perspective has raised concerns that compressing review into such a narrow window – even with early CMC and data drop-ins – inevitably reduces the time available to interrogate anomalies, explore subgroup signals, or coordinate with advisory committees. FDA reserves the right to extend the clock if data are incomplete or ambiguous, but frequent use of that escape hatch would undercut the core promise of CNPV and create uncertainty for sponsors.  

There is also a more subtle legitimacy problem. Because CNPV selection rests on broad “national priority” criteria – public-health crises, supply-chain resilience, affordability, and so on – critics worry the program blurs the line between scientific regulation and economic or foreign-policy objectives. Some have noted that linking ultra-fast review to issues such as onshoring and pricing risks turning individual drug decisions into instruments of industrial or trade policy, inviting accusations of politicization when controversial products or companies benefit. 

If the first cohorts of voucher recipients are perceived as skewed toward firms with political connections, heavily marketed disease areas, or headline-friendly narratives, the program could erode public trust in FDA’s impartiality, even if the underlying science meets all statutory standards. 

Equity and predictability 

Finally, CNPV may deepen a two-tier system in which well-resourced sponsors that can pre-plan CMC, pricing commitments, and domestic-manufacturing narratives reap the benefits, while smaller or less sophisticated developers are effectively locked out. Guidance documents and FAQs still leave significant ambiguity about how FDA weighs competing priorities, how many vouchers will be issued, and what metrics will be used to judge success. 

Unless the agency tightens its criteria, reports transparently on trade-offs (including impacts on non-CNPV reviews), and engages Congress on a clearer legal framework, the pilot could come to be seen less as a targeted tool for national priorities and more as a high-stakes, poorly governed exception to the normal rules. 

Conclusion 

Viewed in full, the Commissioner’s National Priority Voucher program is best understood as an audacious experiment in re-ordering FDA’s workload around a contested notion of “national interest.” The 30–60-day, high-touch review model on top of existing expedited pathways and using a small, highly curated set of products to pursue several goals at once has both promising attributes as well as practical concerns. 

The ambitions of the CNPV program make it politically attractive, but they also amplify the stakes of getting the governance right. The program’s extra-statutory footing, broad and sometimes opaque selection criteria, and heavy resource demands raise legitimate questions about legal authority, transparency, and potential spillover effects on the rest of FDA’s docket. Early recipients suggest a coherent policy thesis, yet they also underline the risk that voucher decisions will be perceived as one-off deals rather than the predictable application of clear standards. Going forward, the fate of CNPV will hinge less on how many “wins” it can claim and more on whether FDA can demonstrate that faster decisions did not come at the expense of rigor, fairness, or trust in the broader regulatory enterprise.