FDA to award Commissioner’s National Priority Vouchers under a new pilot program aligned with U.S. national interests
The U.S. Food and Drug Administration has announced a new Commissioner’s National Priority Voucher (CNPV) pilot program. The ultimate goal of the program is ‘to bring more cures and meaningful treatments to the American public’.
There will be a limited number of vouchers issued in the first year 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.
The new CNPV program will:
- reduce drug approval timelines from the standard 10–12 months to as little as 1–2 months following final submission.
- allow companies to submit large portions of their application before clinical trials are complete.
- include enhanced communication between sponsors and FDA reviewers.
- have applications reviewed by a multi-disciplinary team rather than the standard review approach
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. The vouchers are not transferable but are retained if the company is acquired by another company and must be redeemed within 2 years.
