The U.S. FDA announced a new Commissioner’s National Priority Voucher (CNPV) program that will shorten drug review times for companies "aligned with U.S. national priorities.”
The new voucher may be redeemed by drug developers to participate in a priority program that shortens its review time from approximately 10-12 months to 1-2 months following a sponsor’s final drug application submission.
To do this, the 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.
The agency plans to run a one-year pilot program, beginning this year, in which the FDA will give a limited number of vouchers to companies aligned with U.S. national priorities. After the pilot is concluded, the FDA may increase the number of CNPVs available.
According to the agency, it will use specific criteria — which were not outlined in the press release — 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. The FDA said it will provide information “in the near future” on how companies seeking a voucher can indicate their alignment with the FDA Commissioner’s national priorities criteria.
Vouchers can be directed by the FDA towards a specific investigational new drug 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 non-transferrable.