FDA’s National Priority Voucher Program Is Just a Modular PMA Rebrand, With Risks

In June 2025, FDA announced its new Commissioner’s National Priority Voucher (CNPV) program, a headline-grabbing reform that promises to potentially cut select drug review timelines from 12 months to just 1-2 months. Designed for companies aligned with national health priorities, the program was unveiled with confident language, tumor board metaphors, and the familiar spirit of disruption. But beneath the PR gloss lies a reality that those of us with regulatory experience understand all too well: this isn’t new. It’s a rebranding of something FDA already does.

Modular Review: Old Wine, New Bottle

What FDA is now pitching for drugs through CNPVs is nearly identical to the modular Premarket Approval (PMA) process that the Center for Devices and Radiological Health (CDRH) has used for years (see: PMA Application Methods | FDA). I’ve submitted these modular PMA packages myself. The core idea? Sponsors front-load sections of their application (e.g., manufacturing information, non-clinical testing) for early review, while clinical trials are still ongoing. Then, once the pivotal trial ends, the Agency can complete the review in a condensed timeframe.

For devices, this model makes sense. It’s efficient, compartmentalized, and scalable. But applying this same process to drugs introduces several operational and scientific risks that proponents of the program may not have fully acknowledged.

The Illusion of Certainty

The biggest blind spot in this approach is that it undermines the principle of totality of evidence, a fundamental regulatory concept at the FDA. When evaluating an application, each piece of data (clinical, non-clinical, CMC, statistical, technical validation) must be interpreted within the context of the others. Reviewing these components in isolation increases the risk of missing critical cross-domain signals. For example, the absence of hepatotoxicity in animal studies does not preclude the emergence of liver safety signals during human clinical trials, something reviewers can’t assess if they’re siloed.

Yes, FDA could technically revisit previously reviewed sections once the complete data is submitted. But let’s be honest: that rarely happens in practice. The Agency is under pressure, reviewers are overworked, and once a section is signed off, it often stays signed off. This increases the risk that incomplete or selectively curated data will get through the cracks.

A PR Win, But at What Cost?

This appears to be a PR win for FDA. The Commissioner is under a clear mandate to be a disruptive innovator. But disruption without operational readiness is dangerous. FDA is already missing review deadlines due to resource constraints (see: FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’ | BioPharma Dive). Staff are overextended, facing mounting pressure due to shifting expectations, limited resources, and the possibility of another internal restructuring in the near future.

Layering on a new, complex submission model without the backend capacity to support it will lead to rushed reviews, inconsistent scrutiny, and more variability in outcomes. The Agency could adopt certain interactive review methodologies from tumor board-style meetings; however, without dedicated structural support, implementation may be challenging, especially since risk-benefit evaluations in oncology differ fundamentally from those in other therapeutic areas.

Strategic Risks for Industry

For companies, especially startups, this pathway may seem like a fast track to approval. But they should tread carefully. Submitting portions of their application before trial results are in means they assume full risk if the study fails. They may also prematurely lock themselves into review timelines or regulatory commitments that become liabilities once the clinical data is available (e.g., statistically significant efficacy signals are only demonstrated in certain sub-group analyses).

Even worse, partial approvals or early feedback could become misleading. If a company receives tentative sign-off on a section, only to see the Agency reverse its position after clinical data is submitted, it could face costly delays, relabeling demands, or even trial redesigns. Certainty in regulation could be a mirage under these conditions.

Innovation Needs Infrastructure

The Commissioner’s approach draws heavily from his background in oncology, where high-risk decisions and accelerated pathways are the norm. But not all therapeutic areas are oncology. Risk-benefit thresholds differ. Forcing an oncology-style decision framework onto pain management, infectious disease, or neurology could be a form of regulatory overreach.

To truly modernize, FDA will need to be reliant on operational excellence. It needs to address its staffing shortages, implement better technology solutions, and ensure its review model preserves scientific rigor while accommodating innovation. This will require a significant investment in infrastructure.

Final Word: Proceed With Eyes Wide Open

The CNPV program holds significant promise for all stakeholders and may help streamline the approval process in certain cases. However, it is not a comprehensive solution to all regulatory pathways for drugs. Sponsors considering this route should weigh the risks, understand the regulatory precedent (modular PMA), and avoid being seduced by the promise of speed without balancing potential roadblocks.

Options are good. But they are only as valuable as the clarity, integrity, and stability behind them. Strengthening those fundamentals remains essential. While no voucher program, regardless of aspiration, can resolve that overnight, it can and should act as a catalyst for meaningful regulatory innovation at FDA.