The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher may be redeemed by drug developers to participate in a novel priority program by the FDA that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
The new CNPV process convenes experts from FDA offices for a team-based review rather than using the standard review system of a drug application being sent to numerous FDA offices. Clinical information will be reviewed by a multidisciplinary team of physicians and scientists who will pre-review the submitted information and convene for a 1-day “tumor board style” meeting.
“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” said FDA Commissioner Marty Makary M.D., M.P.H. “As a surgical oncologist, we often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers.”
The FDA plans in the first year of the program to give a limited number of vouchers to companies aligned with U.S. national priorities. 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 accelerated approval. The new review program will also include enhanced communication with the sponsor throughout the process. The FDA Commissioner will use specific criteria to make the vouchers available to companies that are aligned with the national health priorities of:
- Addressing a health crisis in the U.S.
- Delivering more innovative cures for the American people.
- Addressing unmet public health needs.
- Increasing domestic drug manufacturing as a national security issue.
To qualify, sponsors must submit the chemistry, manufacturing, and controls (CMC) portion of the application and the draft labeling at least 60 days before submitting the final application. Sponsors must also be available for ongoing communication with prompt responses to FDA inquiries during the CNPV review. The FDA reserves the right 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.
Vouchers can be directed by the FDA towards a specific investigational new drug of a company or be granted to a company as an undesignated voucher, allowing a company to use the voucher for a new drug at the company’s discretion and consistent with the program’s objectives.
This program aims to accelerate the drug review process for companies aligned with U.S. national priorities while maintaining the FDA's rigorous standards for safety, efficacy, and quality.
“This approach capitalizes on frequent communication with sponsors, which can be a powerful tool in reducing wasted time. We are confident this more efficient process can be achieved without cutting any corners on safety or scientific evaluation,” said Principal Deputy Commissioner Sara Brenner, M.D., M.P.H.
The CNPV program reflects the FDA's commitment to create more efficient approval processes and modernize regulatory frameworks for greater agility to meet emerging public health needs.
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