The Food and Drug Administration will complete reviews of certain drugs more quickly, the agency’s commissioner announced on June 17.
FDA Commissioner Dr. Martin Makary said the new Commissioner’s National Priority Voucher program will help reduce the time the agency spends reviewing final applications for drugs.
“Through this pilot, companies will receive a decision within a month or two, as opposed to the typical 10 to 12 months,” Makary said in a video statement.
The program aims to streamline the process by convening experts from various FDA offices to conduct a review, rather than the standard process of sending an application to numerous offices, according to the FDA. A team of doctors and scientists will pre-review the submitted information and hold a one-day meeting to go over it.
To qualify for the program, companies must submit some data at least 60 days before submitting the final application.
Officials said the process is based on so-called tumor board meetings, in which cancer specialists get together to discuss treatment strategies for patients.
“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 June 17 statement.
In the first year of the program, the FDA expects to hand out a limited number of vouchers to companies “aligned with U.S. national priorities,” according to the statement.
Regulators are going to focus on drug developers who are manufacturing domestically, addressing “an unmet public health need,” and working on COVID-19 pandemic preparedness, Makary said.
Vouchers must be used within two years, the FDA stated on a FAQ page on its website. The vouchers are not transferable but remain valid when there are changes in the ownership of a company.
The agency said it will provide additional information soon on how companies can show they’re aligned with the national priority criteria.
The move comes after Makary said he was looking to reduce the time it takes to bring new drugs and other products to market.
Makary and Dr. Vinay Prasad, another top FDA official, said in an article earlier in June that reviews that usually take a year to complete were finished during the COVID-19 pandemic in weeks. They said that was a “clear demonstration that rapid or instant reviews are possible.”
The officials said that their approach to removing red tape would include pre-submissions of some data, and revamping or removing antiquated processes.