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:
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
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.