Editor’s Note:
Check out additional coverage and industry expert perspectives in “The Regulatory Crucible: Risk, Resource Drain, and the Hidden Trade-Offs of the CNPV Pilot Program.”
And check out “How the FDA Commissioner’s National Priority Vouchers Reshape Manufacturing, Pricing & Global Strategy,” as well as “Winners & Losers: What the First FDA Commissioner’s National Priority Vouchers Tell Us About Early Movers vs. Late Movers” from our colleagues over at Pharmaceutical Executive.
The FDA Commissioner’s National Priority Voucher (CNPV) pilot program represents a tectonic shift in the expectations placed upon biopharmaceutical sponsors seeking market entry (1). The program, which utilizes a “collaborative tumor board style review process” and a “multidisciplinary team-based evaluation,” offers the benefit of reducing application review times from the traditional 8-12 months to “just 1-2 months” following submission (1,2). As Commissioner Marty Makary, MD, MPH, stated, the process is intended to use a “common-sense approach… so that we can reduce inefficiencies” and harness a “tumor board style” discussion to deliver “timely decisions for drug developers” (2). However, this unprecedented acceleration mandates that companies must entirely dismantle the traditional sequential launch model and replace it with a demanding framework of pre-submission completion and parallel cross-functional execution, according to industry experts we spoke with.
Does the CNPV program require a shift to a parallel execution model?
The most critical realization for CNPV applicants is that the compressed timeline eliminates the luxury of sequential product launch activities. In a PharmTech Group interview, Henrik Johanning, senior vice president, Quality & Strategy, Epista Life Science, summarizes this radical necessity, stating “When review windows shrink from 10-12 months to as little as 1-2 months, the entire model for launch readiness changes.” He stresses that “the traditional sequential approach, in which regulatory, chemistry, manufacturing, and controls (CMC), labeling, and market access teams work in turn, no longer works.”
To succeed under this accelerated timeline, Johanning says companies need to “shift to a parallel execution model, in which quality, regulatory, and commercial readiness progress in lockstep.” This shift, he notes, “demands mature governance and disciplined cross-functional coordination long before submission.” Metin Çelik, PhD, president, Pharmaceutical Technologies International, Inc (PTI), reiterates this point in a PharmTech Group interview, stating unequivocally that when the regulatory clock compresses, companies “must fundamentally shift key launch-readiness activities to the pre-submission stage.”
This necessity entails a high degree of integration across internal departments, Çelik adds, which should operate through “integrated readiness ‘war rooms’ with weekly cross-functional reviews across CMC, regulatory, safety, medical, commercial, and supply chain.” The ultimate determinant of success in this accelerated environment, according to Johanning, is not the voucher itself, but “how companies structure their internal control and decision-making models to make compressed reviews sustainable.”
Why is pre-submission perfection in CMC and quality systems so critical?
The cornerstone of the CNPV’s speed is the mandatory pre-submission requirement: participants must submit the CMC portion of their application (or efficacy supplement (ES)) and their proposed labeling “at least 60 days before submitting their complete application/ES” (1,2). This front-loading of technical information means that manufacturing and quality robustness must be near perfection at the time of filing.
Çelik clarifies that manufacturing and supply chain readiness, encompassing “tech transfer, process performance qualification, control strategy, domestic/dual sourcing, quality system robustness, …must be essentially complete at submission.” The penalty for non-compliance, he adds, is severe given the time constraint, “with a potential 30-60-day review, there is no time to fix compliance gaps once the file is submitted.” Johanning adds that compressed timelines “amplify every weakness in a company’s quality risk management (QRM) framework.” Therefore, he continues, the most prepared organizations “use QRM not only as a compliance tool, but as a decision-making compass.”
Companies must mitigate these risks proactively. Çelik recommends that they “invest early in CMC strength and supply chain resilience” and utilize systems for “structured risk assessments, documentation frameworks, and predictive readiness analytics aligned with FDA expectations.” Johanning advises that sponsors “run a risk-based readiness sprint before applying.” This sprint, he says, involves critical steps like locking “CMC and control strategies, verifying tech-transfer and supply-chain qualification (ideally US-based), aligning labeling and process validation plans, and ideally rehearsing day-0 to day-30 responses,” because “the clock starts the moment you file.”
In an interview with PharmTech Group, Aloka Srinivasan, principal and managing partner at Raaha LLC—who has helped a CNPV winner with their application and paperwork and is now getting them ready for the project—reinforces that while the formal review time shrinks, it “does not imply that product development, marketing preparation, or post-approval planning must also be compressed proportionally.” Instead, the expectation is that by the time the application is submitted, “both the sponsor and the Agency should already have resolved key risks, making approval largely a formality.” For generic products, Srinivasan notes, the CMC information could be provided “many months in advance,” leaving bioequivalence as potentially “the only major remaining issue to address after the formal submission.”
The complexity also extends to external logistics, such as facility inspections. Rory Budihandojo, an independent good manufacturing practices consultant, notes in a PharmTech Group interview that it is “not clear how the FDA (alters) other activities to get the drugs to the market faster (e.g., getting the pre-approval inspection, or PAI, coordinated within that 1-2 months frame).” This uncertainty further pressures sponsors to ensure proactive inspection preparation, which Çelik calls “mission critical.”
How must commercial and pricing strategies integrate with the CNPV’s affordability mandate?
Beyond technical readiness, commercial and market access strategies must also be accelerated. Çelik insists that “market access strategy, pricing scenarios, health economics and outcomes research (HEOR) models, and payer engagement must begin during late-phase clinical development—not after filing.” Furthermore, he says, “labeling strategy and competitive positioning require early alignment because the opportunity for iterative dialogue with FDA becomes limited.” Srinivasan confirms that sponsors “will need to advance market access, pricing, and post-approval readiness activities in parallel.”
Crucially, commercial strategy must integrate one of the CNPV’s explicit criteria: Increasing affordability (1). FDA specifies that this “could include a company that lowers the U.S. price of a drug or reduces other downstream medical utilization to lower overall healthcare costs” (1,3) Makary also notes that vouchers are granted when the company has “agreed to increase affordability” (4).
Sarah Emond and Daniel Ollendorf characterized this focus on cost as a “marked and notable departure for the FDA, an agency that has been clear in the past that drug costs are not its purview or responsibility” in Health Affairs Scholar (3). They noted that the Makary’s statement included the concept of agreeing to price the drug under “Most Favored Nation” drug pricing, pointing out that this concept is “problematic because the United States is frequently where new drugs are launched first, so in most cases, there would not be any other prices to reference” (3). Instead of relying on foreign pricing mechanics, Emond and Ollendorf proposed an innovative solution: “drugs approved through the pathway should be required to be priced to value,” an approach they said ensures that “a price charged society by the drug manufacturer is tied to how much better it makes patients feel” (3).
Emond and Ollendorf explained that the use of cost-effectiveness analysis, a cornerstone of value assessment, “can summarize the costs a new drug would introduce to the system, the savings it might provide by keeping patients out of the hospital or emergency room, and how it might improve both survival and quality of life during treatment” (3). This analysis “can suggest a fair and affordable price for the benefits a drug provides, which aligns with the spirit of the Commissioner’s statement” (3). Companies seeking the CNPV must prepare to demonstrate alignment with these affordability metrics during the late stages of clinical development, long before the application is submitted, adds Çelik.
How should companies leverage enhanced communication and adjust regulatory mindsets?
A key benefit provided to CNPV participants is “enhanced communication throughout the review process” and the use of a rolling review (1). This elevated level of interaction is designed to expedite the process by proactively addressing issues.
Srinivasan characterizes this interaction as a “paradigm change, especially for generics, that needs better understanding.” She states that generic companies that “are usually not used to communicating with the Agency to the extent that do new drug sponsors, will now need to change their mindset and be ready to do so.”
Sponsors must treat these frequent pre-submission discussions strategically, Srinivasan says, advising sponsors to “shift in mindset to take advantage of this support,” treating these interactions as they would handle “information requests” or “discipline-specific” inquiries received after the submission of the dossier. For non-complex generics, this communication represents a “rare luxury as a sponsor of such products has very few ways of communicating with the Agency prior to submission,” she adds. The CNPV, says Srinivasan, guarantees “numerous opportunities to discuss the product and process with the Agency prior to submission of the dossier and the expectation is that by the time they submit the dossier, hopefully most of the issues have been resolved.”
Where does the strategic benefit of onshoring drug development lie?
A primary national priority driving the CNPV program is “onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency” (1,2). This priority, according to FDA, addresses the concern that “the vast majority of the active pharmaceutical ingredients and drug components in Americans’ everyday medicines are supplied from China” (2).
Johanning details the strategic goals of the onshoring criteria, explaining that the FDA is using the program “to steer advanced manufacturing, especially sterile injectables and biologics, back to the US.” The overarching objective, he says, is “to rebuild domestic pharmaceutical capacity after decades of off-shoring to Asia and Eastern Europe.” Specific aims, he continues, include reducing “strategic dependency on single-region, non-U.S. suppliers for APIs and sterile products,” safeguarding “critical manufacturing know-how,” and encouraging “modernization, using US-based continuous-manufacturing or single-use technologies.” Furthermore, according to Johanning, US-based facilities “are easier for FDA to inspect, monitor, and support during scale-up or remediation.” This effort, adds Budihandojo, also provides incentives for firms to “invest and build facilities in the US.”
Srinivasan affirms that the on-shoring benefit is “especially high for generics and biosimilars,” granting them the valuable “significant opportunities to communicate with FDA prior to their submissions.” Johanning clarifies that the focus is less about nationality and “more about where and how you produce.” Thus, foreign firms with “mature GMP systems” can qualify as “voucher-ready” if they “can demonstrate US manufacturing capacity, tech-transfer readiness, and quality oversight aligned with FDA expectations.” The CNPV offers a faster path to market for companies that execute this parallel model effectively, provided they have performed the requisite “careful planning,” concludes Srinivasan.
References
- FDA. Commissioner’s National Priority Voucher (CNPV) Pilot Program. Accessed Nov 18, 2025.
- FDA. FDA to Issue New Commissioner’s National Priority Vouchers to Companies Supporting U.S. National Interests. Press Release. June 17, 2025.
- 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.
- FDA. FDA Awards Second Batch of National Priority Vouchers. Press Release. Nov 6, 2025.
