Industry groups press FDA for transparency, next steps for CNPV program
Industry groups are asking the US Food and Drug Administration (FDA) for greater transparency into its Commissioner's National Priority Voucher (CNPV) pilot, including how the agency intends to transition the pilot into a full-fledged program.
Commenters also raised concerns that the agency may lack statutory authority for the program and asked that it not divert resources from user fee-funded programs to support it. One public advocacy group asked the agency to pause the program to address significant concerns.
FDA launched the CNPV pilot last year to promote certain drugs and biologics that address certain national priorities. The vouchers would make sponsors eligible for significantly shorter review periods and allow more engagement with the agency. Since its inception, FDA has been engaging stakeholders in public settings and receiving feedback on the program through a federal register docket that received almost 600 comments and closed on 30 June. (RELATED: FDA announces new voucher program for drugs tied to national priorities, Regulatory Focus 17 June 2025)
More transparency, predictability
Two major drug industry groups, PhRMA and the Biotechnology Innovation Organization (BIO), wrote to FDA requesting greater transparency and predictability regarding the program. PhRMA said taking such measures would ensure the program is credible, sustainable, and scalable. It emphasized that if the program is to move beyond the pilot phase, the agency should conduct notice-and-comment rulemaking to clarify aspects of the program, including voucher eligibility criteria, selection processes, operational expectations, and timelines.
BIO made similar comments, noting that the program lacks transparency and predictability regarding the legal and regulatory framework that supports it.
"For example, greater clarity around selection criteria could help sponsors determine whether to apply for a CNPV and, if so, for which products," said BIO. "Likewise, transparent CNPV review milestones and action dates would help sponsors ensure readiness for launch at approval.
"Further, BIO strongly recommends that FDA clarify how it intends to ensure that the CNPV Pilot Program is implemented in a way that complies with FDA’s statutory and regulatory authorities and user fee program commitments and does not disrupt procedures available to sponsors," the group added. "For example, FDA should clearly explain, through guidance, how the CNPV Pilot Program complies with FDA’s application review standards and dispute resolution procedures."
BIO also emphasized that FDA should not let the CNPV diminish its current review capacity and said the agency should proactively evaluate the resources it needs to run the program without causing disruptions to its user fee program commitments. PhRMA similarly asked the agency to clarify how it will run the program in parallel with its Prescription Drug User Fee Program (PDUFA) review activities, while accounting for its finite resources. The group said that more clarity is needed on how the program will be resourced, how participation will be calibrated to reviewers' capacity, and how the program may affect PDUFA goal dates and milestones.
PhRMA noted that the agency could better clarify how the vouchers and incentives of the program work, given the differences between CNPV and the agency’s other voucher programs.
"Unlike statutory priority review vouchers, the Program’s vouchers are non-transferable to other companies and rely heavily on established expedited review tools and enhanced engagement on the application under review rather than a tradable incentive," said PhRMA. "Clarifying the nature of the Program as an expedited review mechanism could help better align stakeholder understanding with the Program’s structure and operation."
Echoing BIO, PhRMA elaborated in its letter to FDA on the clarifications it seeks from the agency regarding the selection process, enhanced regulatory requirements, engagement expectations, review timelines, program evaluation, and the program's future. PhRMA also emphasized the need to ensure the program operates within the agency's existing statutory authority and that the approval process remains independent from non-statutory considerations.
"Clear governance structures, transparency, documented decision-making processes, and consistent application of eligibility criteria are essential to maintaining public trust," said PhRMA. "FDA should therefore ensure appropriate procedural safeguards by clearly articulating the basis for accepting or declining requests, applying consistent standards across therapeutic areas, and ensuring that participation in the Program does not lower evidentiary standards for approval.
"Legal and policy considerations that warrant attention as the Program evolves include interaction with PDUFA milestones and goal dates, governance and escalation mechanisms, and FDA requests for information related to sponsor communications," the group added. "Any such requests should be appropriately scoped to ensure they remain focused on information relevant to the Program and can be addressed efficiently by both sponsors and FDA."
Expanding eligibility
The Association for Accessible Medicines (AAM) also noted that CNPV was established without FDA's usual process of first taking stakeholder input. As a result, the group said the program has been criticized for a lack of clarity and transparency, which has led to less predictability and limits its use to healthcare product companies.
"Its current implementation also risks undermining the FDA’s credibility and eroding trust in the agency," said AAM. "If FDA plans to continue or expand the program, we urge it to formally establish the framework through traditional processes, such as regulations and guidance, that allow for public input.
"We also recommend that FDA adopt clear, equitable eligibility criteria and procedures for obtaining a CNPV, and conduct periodic evaluations to assess whether the program is working as intended and whether changes are needed to better achieve its goals," the group added.
AAM’s biggest issue with the pilot is that only new drug applications (NDAs), biologics license applications (BLAs), and, presumably, NDAs and BLAs with manufacturing or efficacy supplements are eligible for a CNPV voucher. The group stated that means it leaves out generic drugs submitted under abbreviated new drug applications (ANDA) and biosimilars authorized under BLAs, which the group argues should be part of the voucher program.
"As noted above, generics and biosimilars are the cornerstone of the American healthcare system, representing 90 percent of prescriptions filled but just a fraction (12 percent) of prescription drug spending," said AAM. "With the exception of 'innovative breakthrough therapies,' generics and biosimilars fit all of the identified national priority areas—including unmet medical need."
AAM argued that FDA should reconceptualize its product definition to ensure that generics and biologics can be accepted into the program. Besides meeting unmet needs, the group also argued that generics and biologics companies have been working to enhance supply chain resilience, including onshoring manufacturing, and are making products more affordable, thereby significantly advancing national priorities by making treatments more accessible.
"In summary, we strongly urge FDA to include generics and biosimilars in the CNPV program as they are essential to achieving most of the identified national health priorities," said AAM. "They were instrumental during the COVID-19 pandemic, and they provide safe, effective, and affordable alternatives to originator products, meeting unmet medical needs by ensuring patients can access their medicines.
"AAM’s members are actively engaged in efforts to bolster the security of the pharmaceutical supply chain by increasing their domestic capacity to rapidly scale up production of essential medicines," the group added. "Generic and biosimilar medicines, which increase the supply of—and patient access to—safe, effective, and affordable treatments, are, therefore, critical to achieving our national priorities."
A group of brain-interface companies, including Blackrock Neurotech, Precision Neuroscience, Neuralink, Synchron, and Paradromics, also asked the FDA to either expand the CNPV eligibility to include medical devices or create a parallel program for medtech products. The group argued that the five national health priorities listed to qualify for the voucher program also apply to medical devices.
"Medical devices can respond to a public health crisis, represent breakthrough technologies, address large unmet needs, strengthen domestic supply chains, and improve affordability just as a drug or biologic can," the brain interface firms. "Indeed, as the FDA’s notice explains, combination drug-device products today are eligible for the NPV Program where a device component is present but the primary mode of action is a drug or biological product.
"Accordingly, the categorical exclusion of devices from the program turns on a semantic classification of a health care product rather than the public health impact it delivers to Americans," the group added.
The brain interface developers noted that FDA received a new mandate under the 21st Century Cures Act to provide priority review for breakthrough technologies, which allows enhanced interactions with agency senior management but does not establish an expedited statutory review timeline. As a result, the group argued that they don't get the accelerated review that some drugs and biologics are eligible for.
The companies argued that their products are especially primed to meet the goals set out by CNPV and noted that helping such companies get a leg up would help the US better compete with foreign adversaries.
"The NPV program represents a critical opportunity to mitigate the risk of foreign adversaries establishing global dominance in the development and commercialization of BCI medical devices and safeguard the sensitive healthcare data of Americans," said the group. "Expanding the NPV Program to medical devices, particularly BCIs, advances the onshoring, supply chain resilience, and national security objectives underlying the NPV Program."
Hitting pause
The public advocacy group Public Citizen also expressed serious concerns about FDA creating CNPV without congressional authority and the fact that it was implemented without the agency's traditional notice-and-comment rulemaking process.
The group said the need for the program was unclear, and that it used changing eligibility criteria based on policy considerations unrelated to the agency's mission of ensuring drug safety and effectiveness. It also said the proposed one- to two-month review timelines are unnecessary and dangerously short, and that there was inappropriate involvement of political appointees and center directors in deciding who receives a voucher and in reviewing products with a voucher.
"Public Citizen urges the FDA to pause the CNPV pilot, refrain from granting additional vouchers, and discontinue the program," said Public Citizen. "The FDA’s established pathways to expedite the review of drugs and biologics can be effectively used to advance innovative therapies for serious and life-threatening conditions, unmet medical needs, and public health priorities."
