The FDA is introducing a new priority voucher program designed to shorten the drug review process from 10 to 12 months down to one or two months, according to the agency.
The federal outfit’s “Commissioner’s National Priority Voucher” (CNPV) program will include a “limited number of vouchers” for “companies aligned with U.S. national priorities,” according to a June 17 press release.
"These vouchers are non-transferrable," an FDA spokesperson told Fierce Biotech. "However, they will remain valid through changes in company ownership."
FDA Commissioner Marty Makary, M.D., will determine a company’s eligibility for CNPV by assessing whether the biopharma is addressing several national priorities.
Without providing specifics, the FDA said the vouchers will go to companies that are addressing a U.S. health crisis, "delivering more innovative cures," addressing unmet public health needs and boosting domestic drug manufacturing.
Vouchers can be tied to a specific investigational drug or can also carry an “undesignated” status for a company and be used for the biopharma’s novel drug of choice.
The new program also includes “enhanced communication with the sponsor throughout the process,” according to the release.
A company with the voucher can still receive an accelerated approval if its candidate meets the applicable legal requirements for that approval pathway.
To qualify, sponsors must submit chemistry, manufacturing and controls (CMC) and draft labeling information at least 60 days before submitting a final application.
For companies using the vouchers, the agency will aim to make approval decisions one to two months "following a sponsor’s final drug application submission," according to the release.
The agency said it could still extend the review timeframe “if the data or application components submitted are insufficient or incomplete, if the results of pivotal trials are ambiguous or if the review is particularly complex.”
The CNPV process will consist of multiple experts from FDA departments conducting a one-day team-based review “rather than using the standard review system of a drug application being sent to numerous FDA offices,” the agency said.
“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,” Makary said in the release. “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 voucher will expire after two years, according to the agency.
The move comes just one day after China announced a proposal to cut down its clinical trial review waiting period for novel medicines to from 60 working days to 30 days. If implemented, the new review timeline would match the FDA’s 30-day period.
The new process also emerged after the FDA faced a widespread reorganization that included staff cuts across the agency. Since the restructuring, multiple companies—such as GSK and KalVista—have faced delays in the drug review process due to the agency.
Just last week, Makary shared priorities for the FDA, including the use of AI to speed up drug reviews and deliver decisions within weeks.
In addition to using generative AI tools, Makary intends to speed up approval review times by asking applicants to submit materials like manufacturing plans, draft labels and packaging before trials are complete—similar to the new CNPV process.