Since its introduction nine months ago, the FDA’s National Priority Voucher Testing Program has drawn intrigue and fierce criticism, while also leading to faster approvals for some drugs. With all of this buzz surrounding the program, the agency is now planning to solicit public feedback and consider potential adjustments.
The FDA has scheduled a June 12 hearing to hear comments on the Secretary’s National Priority Voucher (CNPV) program, which was introduced last June. In parallel to the in-person event at FDA headquarters in White Oak, Maryland, commenters will have the opportunity to voice their CNPV feedback virtually both before and after the event and during the hearing.
The CNPV program, which aims to prioritize drug reviews for products that align with vague “national interests,” has drawn high-profile criticism and fueled internal conflict within the agency. Under the CNPV pathway, the agency aims to issue drug approval decisions within one to two months, much shorter than the six months for priority review and 10 months for standard review.
The agency said it is considering CNPV reviews for products that aim to respond to public health crises, introduce innovative breakthroughs, target large-scale unmet needs, strengthen domestic manufacturing, and improve the affordability of medicines.
The program was not introduced through Congress, and two lawmakers shared “deep concerns” that it could “enable corruption by creating new and lucrative gifts for pharmaceutical companies and allies that President Trump supports politically.”
Additionally, the lawmakers shared concerns that the “rushed” nature of the CNPV review could “undermine public confidence in FDA decisions.”
The hearing will include officials from multiple FDA offices, including the Office of the Commissioner, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence.
According to Friday’s announcement, the FDA will use the public hearing to “seek feedback on the program’s eligibility criteria, voucher selection process, sponsor responsibilities, pre-submission requirements, FDA review procedures, the role of the CNPV review board, and other aspects of program implementation.”
When the FDA announced the pilot program last year, it was difficult to say exactly what the effort would be. Since then, the agency has conducted 18 ultra-rapid drug reviews (including aggressively assigning reviews based on impressive research data) and granted CNPV approval to Novo Nordisk, Johnson & Johnson, Boehringer Ingelheim, and U.S. Antibiotics.
The CNPV program has also experienced drug rejections, with Disc Medicine’s rare blood disease candidate vitopertin missing evaluation last month.
