FDA Voucher Plan to Reduce Drug Review Times

The FDA announced a new initiative designed to expedite the drug approval process for companies that align with U.S. national health interests. Unlike traditional review timelines of 10-12 months for final drug applications, the Commissioner’s National Priority Voucher (CNPV) program allows eligible applications to be reviewed in just 1-2 months.

These vouchers will be granted to drug developers that contribute to critical national health priorities established by the Food and Drug Administration (FDA) Commissioner, such as addressing a health crisis; delivering more innovative therapies; addressing unmet public health needs; or significantly increasing U.S. national security, such as through domestic drug manufacturing.

The pathway is not meant to replace existing fast-track programs and instead leverages a team-based, multidisciplinary review model that includes a one-day, “tumor board style” meeting to ensure timely and coordinated evaluation. The vouchers are non-transferable and must be used within two years. The FDA has said it may expand the number of vouchers following a one-year pilot.

This announcement is the latest in a series of FDA actions aligned to Commissioner Marty Makary’s priorities of expediting reviews, increasing efficiency, limiting conflicts of interest, and modernizing the agency. Information on how the CNPV program will run and how manufacturers can apply for a voucher remain unknown.