Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments

Jordan Despanie, PhD, advocates for the continuation and formalization of the Commissioner’s National Priority Voucher (CNPV) pilot program to enhance U.S. biopharmaceutical competitiveness and supply chain security. The commenter proposes a framework to transition the pilot into codified rulemaking that balances rapid regulatory review with scientific integrity through transparent criteria, a dual-track review process, and public auditing.

The American Association of Neurological Surgeons (AANS) and the Congress of Neurological Surgeons (CNS) support the FDA's Commissioner’s National Priority Voucher (CNPV) Pilot Program and advocate for its expansion to include certain medical devices. They recommend implementing rigorous eligibility standards, requiring more detailed voucher submissions, establishing robust post-market oversight, and creating a metrics-driven framework to evaluate the program's performance.

PhRMA, a trade association representing biopharmaceutical research companies, supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program as a way to accelerate patient access to therapies addressing national health priorities. They urge the FDA to formalize the program through notice-and-comment rulemaking to ensure transparency, predictability, and clear eligibility criteria while maintaining scientific rigor.

60 Degrees Pharmaceuticals, Inc. supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program but recommends making non-designated vouchers transferable and allowing sponsors to elect their voucher type. The company argues that transferability is essential for small, single-asset developers to secure the capital needed for clinical development and commercialization of treatments for underserved diseases like babesiosis.

The National Center for Health Research (NCHR) opposes the Commissioner’s National Priority Voucher (CNPV) Pilot Program as currently designed, arguing it lacks transparency, scientific rigor, and clear justification over existing expedited pathways. They urge the FDA to discontinue the pilot or make substantial revisions to remove non-scientific criteria like affordability and domestic manufacturing from the selection process.

The Connected Health Initiative (CHI), a multistakeholder policy and legal advocacy organization, supports the Commissioner’s National Priority Voucher (CNPV) Pilot Program. They urge the FDA to expand the program to include medical devices, specifically highlighting wearables and AI-driven software, to address the chronic disease crisis and clinician shortages.

The Connected Health Initiative (CHI), a multistakeholder policy and legal advocacy organization, supports the FDA's CNPV Pilot Program and urges the agency to expand it to include medical devices. They argue that extending the program to devices like wearables and SaMD AI would catalyze innovation, reduce regulatory uncertainty, and address the national chronic disease crisis.

Prime Therapeutics LLC supports the FDA's proposed CNPV Pilot Program as a way to accelerate access to innovative therapies and strengthen the supply chain. However, they request greater transparency regarding the selection process, clearer definitions of national health priorities, and a dedicated website to track post-marketing commitments and program outcomes.

The Cystic Fibrosis Foundation supports the development of innovative therapies but urges the FDA to temporarily pause the CNPV pilot program to process stakeholder feedback and ensure consistent standards. They also recommend using the formal notice-and-comment process for future rules, increasing transparency in the selection process, removing political influence from the review council, and excluding pricing or manufacturing criteria from eligibility.

The diaTribe Foundation supports the goal of the Commissioner’s National Priority Voucher (CNPV) Pilot Program to expedite the approval of innovative therapies for unmet health needs. However, they recommend eliminating the CNPV Review Council to prevent political influence, conducting a workload study to ensure non-CNPV applications aren't delayed, and increasing transparency regarding selection criteria and patient involvement.