June 29, 2026
Re: Docket No. FDA-2026-N-2366 for “Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments.”
The National Center for Health Research (NCHR) appreciates the opportunity to comment on FDA’s Commissioner’s National Priority Voucher (CNPV) Pilot Program. NCHR is a nonprofit, nonpartisan organization dedicated to ensuring that medical products and health policies are grounded in strong scientific evidence and serve the needs of patients and consumers. Through independent analysis of medical and scientific data, our experts work to strengthen the safety and effectiveness of medical products, improve health policy, and protect patients, consumers, and communities.
We strongly support the FDA’s mission to ensure timely access to safe and effective therapies, especially for serious and life-threatening conditions. However, the CNPV Pilot Program, as currently designed, raises serious concerns about transparency, conflicts of interest, scientific rigor, FDA resources, and public trust. We urge FDA to discontinue the CNPV pilot or undertake substantial revisions to it before any additional products are reviewed. If it is to continue, FDA must place the program on a clear statutory or regulatory footing, with transparent eligibility criteria, public accountability, and safeguards to ensure that drug approval decisions remain based on safety, effectiveness, and sound science.
The first step is to use the appropriate regulatory process, including an unbiased Advisory Committee that meets according to the standard process.
- Eligible Applications and Scope:
The FDA’s CNPV priority areas (public health crisis response, breakthrough therapies, and large unmet medical needs) overlap with existing expedited pathways. The FDA has not made a persuasive case explaining why those pathways are insufficient, therefore failing to justify creating a parallel ultra-accelerated review program that gives selected sponsors extraordinary access to limited FDA review resources. This is especially true given the loss of many of the most experienced scientific staff.
Several products selected for CNPV already apparently qualified for existing FDA expedited programs. Hernexeos (zongertinib), approved for certain adults with unresectable or metastatic non-squamous non-small cell lung cancer with HER2 mutations, had already received ‘Breakthrough Therapy’ and ‘Priority Review’ designations (FDA, Feb 26, 2026). If a product already qualifies for established expedited pathways, the FDA should explain why an additional CNPV voucher is necessary rather than using existing tools. Without such justification, CNPV raises concerns that it is duplicative rather than necessary.
Affordability and Onshoring Criteria Require Congressional Action Rather Than Preferential FDA Review
The affordability and onshoring criteria should be removed from CNPV selection criteria because they are not part of FDA’s core safety-and-effectiveness mission. Drug pricing, patient affordability, domestic manufacturing incentives, and supply chain policy are important national issues, but they require Congressional action and coordination across agencies with the appropriate authority and resources. At a time when the FDA is facing staffing constraints and heavy review workloads, it should not take on broad economic or industrial-policy goals when its primary responsibility is to determine whether medical products are safe, effective, and appropriately manufactured. Including affordability or domestic manufacturing in voucher selection creates the perception that non-scientific or political considerations are influencing which products receive special review treatment. Moreover, it is clearly inconsistent with FDA’s approval criteria: the agency says it never considers the inevitably higher cost of new medical products when it approves ones that are neither safer nor more effective compared to medical products that are already on the market. If lower price is an important criterion, it should be considered for all FDA approval decisions, and that would require a change in the law.
Narrowing Eligibility If CNPV Continues
If CNPV were to continue in any form, inclusion criteria should focus only on clearly defined scientific and clinical criteria within FDA’s scientific and regulatory expertise and jurisdiction. It should limit eligibility to New Drug Applications (NDAs), Biologics License Applications (BLAs), and relevant supplemental applications for serious or life-threatening conditions with substantial unmet need, strong evidence readiness, and complete, high-quality applications. The FDA should not expand the pilot or consider a pathway that broadens product types or earlier development stages. Excluding medical devices is appropriate, and combination products should qualify only when the primary mode of action is a drug or biologic.
- Selection Process
As stated above, the current CNVP pilot program is fatally flawed because the FDA has not sufficiently justified the need for the CNVP or the availability of adequate resources to support the program without reducing resources for other FDA pathways and therefore harming the patients that rely on the FDA’s review of other medical products. The FDA must urgently revise the national priority criteria because they are fundamentally problematic and lack clarity, resulting in many physicians, researchers, and patients unable to understand why certain products are selected and others are not, and believing that non-scientific factors too often determine which sponsors benefit from the program. As currently described, the process seems to be designed to please industry and Members of Congress and patient groups supported by industry, and to make political points at a time when the FDA was being bashed in the media by those same entities.
Information Sponsors Should Provide
To justify participation in any CNVP, sponsors should clearly specify the target patient population, evidence of meaningful clinical benefit, unmet need, trial design, key safety uncertainties, Chemistry, Manufacturing, and Controls (CMC) readiness, inspection readiness, and whether the product already qualifies for an existing expedited pathway. The FDA should publish a publicly available rationale explaining why the product was selected, which priority area it met, what evidence supported selection, and what safeguards apply. We question how many drugs that the FDA has thus far selected would meet the criteria we recommended above.
Augmentin XR Shows the Risks of Non-Clinical Selection Criteria
For example, FDA’s approval of Augmentin XR under CNPV illustrates the need for clearer guardrails around non-clinical selection factors (FDA, Dec 9, 2025). Augmentin is a well-established antibiotic with meaningful clinical benefit, and addressing antibiotic shortages is an important public health goal. However, FDA stated that the application for Augmentin XR aligned with CNPV priorities because it strengthened the U.S. drug supply chain through enhanced domestic manufacturing capacity at a U.S. facility. Commissioner Marty Makary also stated that the approval would “strengthen domestic manufacturing and increase our national security.” In contrast, the scientific evidence indicates that it is significantly more expensive than generic versions of Augmentin and is considered merely “as effective,” not more effective than these generic versions. If the FDA thinks cost should be a criterion, this CNPV decision clearly fails. The fact that it only needs to be taken twice a day rather than three times a day clearly does not justify an urgent need or other patient-centered criteria for rushing its review as part of the CNPV program.
FDA Must Define and Verify Domestic Manufacturing Claims
To be credible, FDA must clearly explain how domestic manufacturing and supply chain considerations are weighed against the Agency’s traditional safety-and-effectiveness framework. These criteria are questionable, but the FDA should at least clearly define what “domestic manufacturing” means: is it production of the active pharmaceutical ingredient, drug substance, finished product, packaging, testing, or only one part of the supply chain; whether the U.S. facility is already operational and inspection-ready; whether the sponsor has committed to sustained production volume; and how FDA will verify that the approval meaningfully improves access and reduces shortage risk. Without clear definitions, measurable commitments, and public follow-up, domestic manufacturing claims will not translate into reliable patient access and benefit.
- FDA Staffing Capacity and Expedited Review Demands
Enhanced engagement may improve efficiency, but the CNPV pilot’s one- to two-month review target and rapid response expectations place excessive strain on FDA staff, which remains weakened by the loss of employees, and especially senior level staff. A program that gives selected applications intensive, around-the-clock attention will inevitably divert reviewers, inspectors, statisticians, and clinical experts from other pending applications probably of greater public health importance, while also increasing the risk of incomplete evaluation of safety and efficacy data, overlooked manufacturing or quality issues, and inadequate assessment of labeling and post-market risks. The FDA should not assume that compressed timelines, templates, or AI tools can compensate for the loss of experienced staff, expertise or the time needed for rigorous scientific review.
- Operational Safeguards and Resource Accountability
The 24–48-hour response window should apply only to clarifying questions, not complex safety, efficacy, statistical, manufacturing, or inspection issues. Sponsors should submit a readiness and staffing plan before accepting a voucher, and the FDA should confirm that the relevant review division has adequate staffing and resources without compromising other reviews. Discussions about the drug’s official label (including indications, warnings, and usage instructions) should not be capped if major safety, efficacy, or benefit-risk issues remain unresolved.
- Review Process and Future Direction
If the CNPV program continues, the FDA should make clear that the timeline is aspirational, not binding, and that reviewers may extend the review clock whenever needed to fully assess safety, efficacy, manufacturing quality, labeling, and post-market obligations.
We agree with the many experts who think that the Review Council completely undermines the credibility of CNPV by politicizing the FDA approval process. Any involvement by political appointees or external stakeholders raises questions of undue influence, which is exactly the problem that has undermined the FDA’s credibility for the last year and continues to do so despite changes in the FDA’s leadership.
Whether regarding CNPV or other pathways, the FDA urgently needs to implement clear safeguards to prevent political interference, including transparent selection criteria, documented decision-making processes, and public evaluation based on scientific rigor and safety outcomes rather than external pressures or timelines.
Respectfully,
National Center for Health Research
Washington, D.C.
References:
- FDA News Release, February 26, 2026. FDA Grants Second Approval under the National Priority Voucher Pilot Program. https://www.fda.gov/news-events/press-announcements/fda-grants-second-approval-under-national-priority-voucher-pilot-program
- FDA News Release, December 09, 2025. First Approval in Commissioner’s National Priority Voucher Pilot Program Strengthens Domestic Antibiotic Manufacturing Capacity. https://www.fda.gov/news-events/press-announcements/first-approval-commissioners-national-priority-voucher-pilot-program-strengthens-domestic-antibiotic
- https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review
- https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050785s019lbl.pdf
- Sethi, S., Breton, J., & Wynne, B. (2005). Efficacy and safety of pharmacokinetically enhanced amoxicillin-clavulanate at 2,000/125 milligrams twice daily for 5 days versus amoxicillin-clavulanate at 875/125 milligrams twice daily for 7 days in the treatment of acute exacerbations of chronic bronchitis. Antimicrobial agents and chemotherapy, 49(1), 153-160.