The Commissioner’s National Priority Voucher Pilot Program

08/26/2025

On June 17th, 2025, the U.S. Food and Drug Administration (FDA) introduced its Commissioner’s National Priority Voucher (CNVP) pilot program to accelerate development of select drugs or biologics from companies that are supporting U.S. national interests and are aligned with U.S. national health priorities. The goal of the CNPV is to advance the broader America First agenda by accelerating cures and meaningful treatment with historic public health impacts for Americans, especially including common chronic conditions and high prevalence diseases. Companies who receive one of these vouchers will be entitled to benefits that include an expedited review period of their product from 10-12 months down to 1-2 months, enhanced communication with the FDA throughout the review process, and the potential for accelerated approval of their product. This expedited process will use a multidisciplinary team-based approach, the team will consist of the FDA's Chief Medical and Scientific Officer as well as other senior physicians and scientists who will pre-review the submitted product information in a “tumor board style” one-day meeting. The program will be distributing no more than five vouchers in the year of 2025. If the pilot is a success, then more will continue to be granted in following years.

There are five U.S. national health priorities considered in the FDA’s selection process for which companies should receive a voucher that are meant to enhance the health interest of Americans:

1.   Addressing a U.S. public health crisis: This includes companies making flu vaccines such as those developed during the COVID-19 pandemic.

2.   Delivering more innovative cures for the American people: This priority focuses on looking for breakthrough novel therapies and healthcare.

3.   Addressing unmet medical need: The focus here is on therapies for conditions that do not currently have or have inadequate treatment such as rare diseases, or addressing the American chronic disease crisis.

4.   Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency: This priority is looking to incentivize manufacturers to shift away from outsourcing manufacturing to foreign facilities and towards manufacturing in the U.S. It is also looking for trials that maintain robust U.S. enrollment in the studies to support generalizability for Americans.

5.   Increasing affordability: The final priority is looking for companies that could lower the price of drugs and other downstream medical.

In order for a company to be eligible to receive a Voucher they must align with or more of the priorities above, each compnay may only submit one application. At this time, companies who wish to be considered for the CNVP are asked to provide a statement of interest that contains:

1.   Company Information: Name, email, number etc.

2.   Which national health priority the company addresses in their drug development: Referring to the 5 listed above.

3.   A ~350-word description of the priorities addressed.

For those interested in submitting an application and for further information, please see the following link to the FDA’s website; https://www.fda.gov/industry/commissioners-national-priority-voucher-cnpv-pilot-program. There is also an FAQ page that contains the FDA’s responses to inquires about the program.

-The Clinical Pathways Team

Enjoy this blog? Please like, comment, and share with your contacts.