CNPV Deep Dive: Perspectives on Accelerated FDA Review From the C-Suite to the Manufacturing Floor

In mid-November 2025, PharmTech Group convened a panel discussion with five bio/pharmaceutical industry experts to analyze the implications of the FDA Commissioner’s National Priority Voucher (CNPV) pilot program (1). At the same time, our colleagues at Pharmaceutical Executive, Applied Clinical Trials, and Pharmaceutical Commerce spoke with expert advisors and subject matter experts in academia to understand their perspectives on the CNPV. The program has garnered significant attention because it offers an "unprecedented opportunity to reduce drug and biological product application or efficacy supplement review times from 10-12 months to just 1-2 months" (2,3). FDA Commissioner Marty Makary, MD, MPH, characterized CNPV as a “common-sense approach” designed to harness a "tumor board style" discussion to deliver "more cures and meaningful treatments to the American public” (3). However, this accelerated pathway comes with a warning from experts in public health and regulatory policy that this speed may come at the expense of established safety standards and fiscal responsibility (1,4-6). The pilot is proving to be far more than just a speed boost; it is reshaping how sponsors approach manufacturing, market access, and their relationship with the regulator.

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How must sponsors fundamentally shift their operational playbook to meet compressed timelines?

The dramatic compression of the review window necessitates a complete overhaul of a sponsor’s traditional drug development and submission playbook. The reduction in formal review time does not mean that product development, marketing preparation, or post-approval planning must also be compressed proportionally. Instead, sponsors must execute market access, pricing, and post-approval readiness activities in parallel with development.

John Kirk, principal regulatory strategist at Veristat, underscores the essential pre-submission timeline, noting that "To use a voucher for the short review period, sponsors must submit the CMC section of the marketing application at least 60 days before submitting the complete application." This mandate fundamentally changes the required speed of internal operations, meaning that manufacturing must be "commercially ready sooner than necessary for a standard NDA." Kirk adds that clinical trials needed for the marketing application must be "completed on time and be of high quality to facilitate review and pre-approval inspections."

Metin Çelik, PhD, president of Pharmaceutical Technologies International, Inc (PTI), details the strategic implications for commercialization: "Market access strategy, pricing scenarios, health economics and outcomes research models, and payer engagement must begin during late-phase clinical development—not after filing." Furthermore, Çelik asserts that "Manufacturing and supply chain readiness (tech transfer, process performance qualification, control strategy, domestic/dual sourcing, quality system robustness) must be essentially complete at submission." To manage this, teams need to operate through integrated readiness “war rooms” with weekly cross-functional reviews across various disciplines.

Aloka Srinivasan, principal and managing partner at Raaha LLC, confirms that for generics and biosimilars receiving a voucher, "What is most important... is careful planning." The new paradigm is defined by the fact that reviews "will occur on a rolling basis with increased interaction between the sponsor and the review team." This support requires a "shift in mindset" for sponsors, who must treat these pre-submission interactions as “information requests” or "discipline-specific" inquiries they are used to getting after the submission of the dossier. Ultimately, the intense pre-submission preparation ensures the final filing will resemble a “first-cycle approval,” in which the "Agency works closely with the sponsor to resolve all issues well before the actual submission is filed".

Is the CNPV program effectively achieving its goal of incentivizing domestic manufacturing?

A major, politically critical objective of the CNPV program is to strengthen the domestic supply chain (1). The program explicitly aims to "incentivize domestic manufacturing of certain critical drugs without cutting corners related to product development or quality," notes Srinivasan. Henrik Johanning, senior vice president of Quality & Strategy at Epista Life Science, confirms that "on-shoring is one of the explicit selection criteria." FDA uses the program to steer advanced manufacturing, especially sterile injectables and biologics, back to the US to "rebuild domestic pharmaceutical capacity after decades of off-shoring to Asia and Eastern Europe" and "strengthen supply-chain resilience," Johanning explains. This domestic focus is considered a prerequisite for accelerated review. Johanning adds that the program also aims to "safeguard, protect, and ‘grow’ critical manufacturing know-how in areas such as biologics, cell therapies, and advanced aseptic systems."

However, the initial CNPV awards suggest that while domestic manufacturing is a priority, it may not be the primary driver of selection. Brad Stewart, National life sciences co leader at BDO, views the National Priority Vouchers as "sort of an evolving opportunity for people." Stewart notes that while onshoring is a stated priority, "out of the vouchers that have been issued, most of them have not been for that reason." In fact, Stewart observes that "There's only been two that were specifically for manufacturing."

Thani Jambulingam, PhD, Professor at Saint Joseph's University, confirms that the first two cohorts of CNPV recipients "are not a random mix of assets." Jambulingam concludes that the winners "weren’t just those with breakthrough science, but those with operational models ready for an accelerated, politically salient, affordability-linked regulatory environment." The awards "reveal a clear bias in favor of companies that were operationally ready to move fast, willing to make explicit affordability and onshoring commitments, and already deeply engaged with the FDA."

How do affordability requirements impact FDA's traditional regulatory role?

The CNPV program introduces an affordability component that complicates traditional regulatory boundaries, particularly concerning cost evaluation. Ed Schoonveld, Value and access advisor at Schoonveld Advisory, explains that affordability is not strictly defined as price cutting, but can also involve "offsetting medical treatments’ total healthcare costs." Schoonveld emphasizes that there are "plenty of opportunities to find other offsets without just focusing on price cutting."

Schoonveld expresses concern about the FDA's potential role in cost evaluation: "What's concerning me a little bit is that it seems that FDA is encroaching in the price-setting cost evaluation domain." While he notes that the CNPV program may not be severely damaging immediately, it could be seen as potentially "a step for the FDA toward getting into that field." Furthermore, Schoonveld questions the logic of accelerated launch tied solely to pricing, arguing that for a company to develop a drug and then "create a quick launch because of a price cut doesn't intuitively make a lot of sense."

Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, provides context on the products receiving vouchers, observing that "a lot of the drugs awarded CNPV vouchers were already-approved drugs for new indications." Conrad notes that this expansion of indications "is helpful on the payer side as it allows them to cover the drugs for a wider range of treatments."

Can FDA manage the logistical and risk implications of a rapid review?

The demand for speed inherently elevates risk, shifting it downstream in the development process. Johanning cautions that "from a risk and compliance perspective, compressed timelines amplify every weakness in a company’s quality risk management framework." With "less time for iterative review and data verification, risks can easily migrate downstream, into supply chain, labeling, or post-market surveillance."

Çelik explains that compressed reviews increase reliance on post-market commitments, including safety studies or risk evaluation and mitigation strategy adjustments, "because uncertainties cannot be resolved during the short review." To mitigate this, companies must prepare post-approval study proposals in advance, "invest early in CMC strength and supply chain resilience," and use digital tools and structured inspection-readiness systems to "anticipate and close gaps before filing." Çelik stresses that proactive preparation is mission critical because "with a potential 30–60-day review, there is no time to fix compliance gaps once the file is submitted."

Regarding logistical feasibility, Rory Budihandojo, independent good manufacturing practices consultant, questions how the agency will cope: "It is not clear logistically how the FDA can provide resources needed for this short/intense review without impacting other FDA review programs." Budihandojo raises concerns that this could divert resources from the standard review program or even other priority review programs, such as the Priority Review Voucher, which expedites review to six months. Ryan Conrad notes that "workload is always an issue and if these reviews are taking up a lot of time and effort from other reviews, that’s not a good thing".

Johanning clarifies that the four-to-eight-week target is conditional, stressing it is only possible "if the dossier is complete and clean," and "the 4-8-week target assumes pre-submission review and flawless CMC." Johanning also confirms that if a sponsor manufactures a product under this program and wants to sell their approval, they cannot, as the vouchers "are non-transferable" and "tied to the specific product and sponsor." However, despite the operational and logistical hurdles, Johanning believes the CNPV is a serious endeavor, calling it "a very focused pilot, not a bureaucracy trap nor window dressing." Sponsors who do not receive a voucher still "retain full access to the well-established expedited pathways (Fast Track, Breakthrough, Priority Review, Accelerated Approval)."

How is CNPV pilot program timing already changing?

Since the above discussions occurred, Augmentin XR, an amoxicillin-clavulanate potassium antibiotic made by USAntibiotics, became the first drug to be approved via CNPV, with FDA saying the approval was completed in just two months (7). Antibiotics, particularly amoxicillin, have been subject to increasing, documented shortages in the past two decades, according to FDA.

"Over the past few decades, America lost control of supply chains for key medicines we depend on,” FDA Commissioner Marty Makary, MD, MPH, said in a press release (7). “That chapter is over—we’re entering a new era of manufacturing here at home. This first drug approval under the CNPV pilot program will strengthen domestic manufacturing and increase our national security."

Then, just one day after phase III trial results were released, Johnson & Johnson’s Tecvayli (teclistamab-cqyv), used in combination with daratumumab to treat relapsed or refractory multiple myeloma, received FDA’s latest national priority voucher, becoming the 16th therapy chosen under the CNPV pilot program. “Within hours of the trial results being published in the American Society of Hematology conference program, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher," said Makary in a press release. "When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly”(8).

The move to award a voucher so quickly suggests the CNPV pilot program timing is dynamic, yet another twist in an era requiring pharmaceutical developers and manufacturers to adapt and pivot on the fly. We at PharmTech will certainly keep a close eye on CNPV developments, so be sure to check back often.

References

1. FDA. Commissioner's National Priority Voucher (CNPV) Pilot Program. Accessed Nov 18, 2025.
2. Dorsey, D; Holland, S. A Tale of Three Vouchers. BHFS.com. Sept 29, 2025.
3. FDA. Commissioner's National Priority Voucher (CNPV) Pilot Program. Accessed Nov 18, 2025.
4. Doctors for America. FDA Commissioner’s National Priority Vouchers Will Endanger Americans. Press Release. June 20, 2025.
5. Eglovitchm, J. Questions Remain as FDA Opens Submissions for New Priority Voucher Program. RAPS.org. July 24, 2025.
6. Emond, S; Ollendorf, D. How to Make One Line in the FDA Commissioner's New Drug Review Program Into a Force for Affordable Access for Patients. Health Aff Sch. 2025;3(10):qxaf182.
7. FDA. First Approval in Commissioner's National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity. Press Release. Last updated Dec. 10, 2025.
8. FDA. FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. Press release. Dec 15, 2025.