FDA Addresses U.S. Health Crisis With Voucher Program

By Katie Anderson, Chief Editor, Pharmaceutical Online

FDA Commissioner Marty Makary, M.D., M.P.H., tapped into his oncologist experience to launch a new FDA program designed to fast-track the time it takes for important drugs to receive approval and get to patients.

The Commissioner’s National Priority Voucher (CNPV) program allows drug developers to reduce review time from 10-12 months to 1-2 months by submitting it to a team-based review rather than standard review. Makary drew inspiration for the program from the multidisciplinary approach he used to design life-saving treatments for patients.

“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 Makary. “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.”  

During the first year of the program, limited vouchers will be granted, and the FDA plans to focus on sponsors that meet national priorities, i.e., addressing a health crisis, delivering an innovative cure, addressing an unmet health need or increasing domestic drug manufacturing.

Sponsors first submit their CMC portion of the application and draft labeling 60 days before the final application. Though the program is estimated at 1-2 months, the FDA reserves the right to extend the process. Sponsors must be available for enhanced communication with the FDA during the process. They may also be granted accelerated approval, if the product for which the voucher is used meets the applicable legal requirements for accelerated approval.