The US Food and Drug Administration (FDA) has unveiled a new programme that will reduce its review time for certain drug applications from around ten to 12 months to just one to two months.
The Commissioner’s National Priority Voucher (CNPV) programme for companies “supporting US national interests” will convene experts from FDA offices for a team-based review, instead of using the standard system of a drug application being sent to multiple FDA offices.
It will also require sponsors to submit the chemistry, manufacturing and controls portion of the application and the draft labelling at least 60 days before submitting the final application.
FDA commissioner, Marty Makary, said: “Using a common-sense approach, the national priority review programme 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.”
In the first year of the programme, the FDA will give a limited number of non-transferable vouchers to companies aligned with priorities such as addressing unmet public health needs, delivering more innovative cures, and increasing domestic drug manufacturing.
The programme will utilise a “tumour board-style” discussion model, with a multidisciplinary team of physicians and scientists reviewing submitted clinical information before convening for a one-day meeting.
“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 one-day tumour board-style discussion,” said Makary. “This voucher harnesses that model to deliver timely decisions for drug developers.”
The programme comes just over a month after the FDA announced that all its centres will operate on a common generative artificial intelligence (AI) system by 30 June this year.
The AI tools have been designed to expedite the drug review process by enabling FDA scientists and subject-matter experts to spend less time on “tedious” and “repetitive” tasks.
“The agency-wide deployment of these capabilities holds tremendous promise in accelerating the review time for new therapies,” Makary said at the time of the May announcement.