Commissioner's National Priority Voucher (CNPV) Pilot Program

Today, approximately three-quarters of young Americans would not qualify for military service without a waiver, often on account of obesity and other health conditions. Additionally, the vast majority of the active pharmaceutical ingredients and drug components in Americans’ everyday medicines are supplied from China. These are two examples, among many others, reflecting severe threats to U.S. national security and the ability of Americans to live prosperous, healthy lives. FDA and the pharmaceutical industry must act with appropriate urgency to advance transformative products and secure our critical supply chains. 

Program Priorities 

The Commissioner's National Priority Voucher pilot program was designed to accelerate the development and review of certain drugs and biological products that are aligned with U.S. national health priorities and to enhance the health interests of Americans. 

Specific priorities include: 

• Addressing a U.S. public health crisis. An example could include developing a universal flu vaccine that could provide broad protection against multiple strains of influenza, including those with pandemic potential. 
• Delivering more innovative cures for the American people. The focus for this priority is transformative impact that far outstrips the threshold for breakthrough therapy designation. Examples could include creating a novel immunotherapy that reprograms the body's immune system to fight multiple diseases; or transforming mental health care through a novel treatment for PTSD. 
• Addressing a large unmet medical need. This includes a condition that available therapies do not adequately diagnose or treat, including drugs to treat or prevent rare diseases or addressing America’s chronic disease crisis. 
• Onshoring drug development and manufacturing to advance the health interests of Americans and strengthen U.S. supply chain resiliency. Examples could include companies with new manufacturing establishments that shift manufacturing of essential medicines (such as generic sterile injectables) from foreign facilities to the U.S.; or a clinical trial that maintains robust U.S. enrollment to support generalizability for Americans against the U.S. standard of care.
• Increasing affordability. This could include a company that lowers the U.S. price of a drug or drugs consistent with Most Favored Nation pricing or reduces other downstream medical utilization to lower overall healthcare costs. 

The program is distinguishable from programs that benefit only limited patient populations. The Commissioner's National Priority Voucher program will advance the broader America First agenda by accelerating cures and meaningful treatments with historic public health impact for Americans, especially including common chronic conditions and high prevalence diseases.

Key Program Features and Benefits

• Faster review times (10-12 months vs. 1-2 months)
• Enhanced communication throughout the review process
• Multidisciplinary team-based evaluation
• Potential for accelerated approval if applicable requirements are met
• Maintains FDA's rigorous safety and efficacy standards

To accelerate review time from approximately 10-12 months to 1-2 months following submission of a pre-market application, the Commissioner's National Priority Voucher program submissions will be evaluated by a senior, multi-disciplinary review committee led by the FDA's Office of the Chief Medical and Scientific Officer, rather than a standard review system of an application being sent to numerous FDA offices staffed by discipline teams with primary and secondary reviewers juggling competing priorities. Participants must submit the chemistry, manufacturing, and controls (CMC) portion of their application and the proposed labeling at least 60 days before submitting the final application.

The Commissioner's National Priority Voucher program will include enhanced communication with companies throughout the process. Participants are expected to be available for ongoing communication with prompt responses to FDA inquiries. The FDA retains full discretion to extend the review window if the data or application components submitted are insufficient or incomplete, if the results of pivotal trial(s) are ambiguous, or if the review is particularly complex. 

Pre-market applications for the Commissioner's National Priority Voucher program products will be subject to the same statutory and regulatory requirements for approval as applications that are not included in the program. In addition to receiving the benefits of this program, the Agency may also grant an accelerated approval if the product for which the voucher is used meets the applicable legal requirements.

For answers to commonly asked questions about this program, please visit our FAQs: Commissioner’s National Priority Voucher pilot program webpage where you can find detailed information and solutions to common queries.