The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.
The FDA launched a new priority review voucher program on Tuesday that it says could shorten the timeline for drug review from 10-12 months to 1-2 months. FDA chief Marty Makary said he modeled the new Commissioner’s National Priority Voucher (CNPV) program after his experience 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,” Makary said in a statement.
The CNPV program will bring together experts from across the FDA for a team-based review, rather than having an application move sequentially through offices within the agency before a decision is made. The experts will get together for a one-day “tumor board style” meeting, according to the press release.
The new vouchers will be offered to companies that are “aligned with U.S. national priorities,” the announcement states. These include addressing a health crisis in the U.S., delivering more innovative cures, addressing an unmet public health need and increasing domestic drug manufacturing as a national security issue. Besides the quick review, the drugs in the program could get an accelerated approval, meaning a therapy can be approved prior to completing a Phase III trial.
In the first year, just a handful of the vouchers will be available. The FDA explained that companies can use the vouchers toward a specific investigational new drug application, or they can be handed out as an undesignated voucher for a new drug “at the company’s discretion” so long as it aligns with the program.
“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. The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary said.
The FDA offers a variety of vouchers to advance certain drugs, such as those for rare pediatric diseases, tropical diseases and medical countermeasures. These can be earned by companies and later sold, creating a marketplace and source of non-dilutive capital for smaller biotechs. The FDA clarified in an email to BioSpace that these vouchers will not be transferable but will be valid through changes in company ownership.
The previous administration under Joe Biden and former FDA chief Robert Califf took strides to advance the accelerated review program and ensure that companies have a confirmatory trial underway prior to submitting a request for a quick review.
Since taking over, Makary has proposed a new conditional approval pathway for rare diseases, although details remain slim. His new Center for Biologics Evaluation and Research chief Vinay Prasad has been critical in the past of the FDA’s use of accelerated approval but had pledged support for finding ways to speed rare disease drugs through the regulatory process.
But the agency has also slashed staff under this new administration, with Makary signaling this week that more cuts may be coming. In recent weeks, cracks began to show in the approval process as companies, including GSK and KalVista, reported delays.
