On June 17, the U.S. Food and Drug Administration (FDA) unveiled the Commissioner’s National Priority Voucher (CNPV) program,¹ a pilot initiative designed to accelerate review and approval timelines for selected products, reducing the standard 10 to 12 months to just one to two months.² Although the program has the potential to bring high-impact therapies to patients faster than ever, it also marks a significant shift in commercialization strategies for life sciences companies preparing for payer access. Additionally, given more recent assertions from FDA officials about the CNPV program, its longevity and evolution could further complicate necessary considerations.³

The following are three critical shifts introduced by the current structure of the CNPV program that manufacturers need to contemplate and the strategic moves that will help them navigate this new landscape.

1. CNPV program selection criteria: Broader opportunities and more competition

The pilot program’s initial cohort of nine products, and subsequent cohort of six products (just recently awarded on November 6, 2025), were selected after submission based on alignment with national health priorities, including (but not limited to):

• Addressing a health crisis in the U.S.
• Bringing innovative therapies to the American public
• Serving largely unmet medical needs
• Increasing affordability or domestic manufacturing of critical drugs and biologics

The spectrum of selected products and therapeutic areas underscores two realities: the program’s broad reach and the potential for intense competition during future selections. To secure a voucher, manufacturers must not only align with the FDA’s national priorities but also distinguish their submissions with meaningful evidence that reinforces their product’s value proposition.

Strategic pharmaceutical manufacturer moves to address this FDA shift:

• Analyze the features of selected products in the first two cohorts and identify gaps in current portfolios to inform potential candidates for CNPV
• Develop submission strategies that emphasize alignment with FDA priorities and demonstrate value to both regulators and payers
• Embed health economics and outcomes research (HEOR) analyses in submission packages to highlight potential healthcare resource utilization offsets and strengthen the clinical rationale for product selection

2. Accelerated FDA timelines and new collaborative review require rapid, strategic pre-approval readiness

Under the CNPV program, the traditional months-long lead-up to a single, large FDA review is replaced with a collaborative, board-style process featuring rolling reviews and ongoing dialogue among the FDA, key opinion leaders (KOLs), and manufacturers. Although this approach may enhance communication overall and accelerate the timeline for approval, it significantly shortens the time manufacturers have to prepare value propositions, refine market access strategies, and align on key messages before review activities begin.

Manufacturers must be ready to engage payers as soon as Phase 3 results are available. Failure to do so risks misalignment with payer expectations, delays in coverage decisions, and lost launch momentum.

Strategic pharmaceutical manufacturer moves to address this FDA shift:

• Establish cross-functional teams (e.g., medical, HEOR, and market access) with clear roles and coordinated strategies ready to engage payers as soon as pivotal data becomes available
• Build rapid-response communication systems and data-sharing protocols that deliver new information to payers and providers in near-real time, enabling faster decision-making
• Prioritize pipeline reviews, including Phase 2 molecules that qualify for CNPV, to generate interest and enable rapid pre-approval information exchange (PIE) engagement once Phase 3 data emerges
• Develop internal capabilities or partner with other industry experts to quickly pivot and develop high-impact materials that drive payer and provider engagement

3. FDA approval does not guarantee immediate payer coverage

Although FDA approval confirms a product’s ability to be sold and marketed, it does not guarantee immediate market access. Payers, pharmacy benefit managers (PBMs), and guideline bodies (e.g., the National Comprehensive Cancer Network [NCCN] and the Advisory Committee on Immunization Practices [ACIP]) may follow different review cycles on different timelines:

• Medicare and Medicaid: Statutory review periods (i.e., 90 days for protected classes in Medicare, 180 days for others) may evolve to support faster access for priority products, but currently, there is no mechanism to align new product assessments (NPAs) with expedited payer review.
• Commercial payers: Complex benefit designs, PBM processes, and regulatory frameworks (state or federal [ERISA] regulations) create unpredictability in time-to-coverage under the new paradigm. Mechanisms for expedited review are fragmented.

This new accelerated FDA pathway requires both life sciences companies and payers to reevaluate their pipeline-related processes. It is essential that they prepare proactively, maintain transparent communication, and adapt their engagement strategies so that patients benefit from expedited regulatory approvals.

Strategic pharmaceutical manufacturer moves to address this FDA shift:

• Map payer decision-making pathways across all relevant lines of business to identify key coverage stakeholders, ensure their awareness of FDA activity, and deliver the right information at the right time to drive coverage decisions
• For medical benefit products, evaluate support needs beyond information sharing, such as product access channels (wholesalers vs. specialty pharmacies), financial considerations (billing codes and/or payer fee schedule additions), and ongoing coverage support
• Establish direct lines of communication among life sciences organizations, payers, and the FDA Commissioner’s office
• Prioritize PBM custom formulary clients for PIE to accelerate adoption
• Partner with patient advocacy communities to amplify the case for formulary adoption and underscore the strengths and integrity of the review process

How life sciences organizations can plan ahead for the CNPV program

The CNPV program has the potential to fast-track lifesaving therapies and redefine how innovation reaches patients. However, with speed comes strain. Compressed timelines and evolving processes will test the timeliness and flexibility of life sciences manufacturers and payers alike.

For manufacturers, success will hinge on keen preparation and the ability to mobilize clinical, regulatory, and market access teams as soon as pivotal data becomes available. For payers and other bodies that inform coverage, it will mean evaluating review processes as FDA guidance emerges to keep pace with this new reality.

Navigating this shifting landscape requires more than just moving fast in reaction to change. It demands deliberate, foresighted action. Manufacturers and payers must preemptively align communications, evidence, and policy so that when changes arise, they are ready to respond with confidence.

¹ FDA. (2025, June 17). FDA to issue new commissioner’s National Priority Vouchers to companies supporting U.S. national interests. Retrieved November 6, 2025, from https://www.fda.gov/news-events/press-announcements/fda-issue-new-commissioners-national-priority-vouchers-companies-supporting-us-national-interests.

² FDA. (2025, November 6). Commissioner’s National Priority Voucher (CNPV) pilot program: Accelerated drug review for companies supporting U.S. national interests. Retrieved November 6, 2025, from https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program.

³ Diamond D., & Roubein R. (2025, November 21). Top FDA drug regulator raises alarms about expediting approvals. The Washington Post. https://www.washingtonpost.com/health/2025/11/21/fda-regulator-richard-pazdur-concerns/.

⁴ FDA. (2025, October 16). FDA awards first-ever National Priority Vouchers to nine sponsors. Retrieved November 6, 2025, from https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors.

⁵ FDA. (2025, November 26). FDA awards second batch of National Priority Vouchers. Retrieved November 6, 2025, from https://www.fda.gov/news-events/press-announcements/fda-awards-second-batch-national-priority-vouchers.