An Associated Press article (here) reported that “Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months.” This would be accomplished by a team of reviewers similar to those formed under Operation Warp Speed for approvals of the COVID-19 vaccines.
“Makary said he will prioritize vouchers for companies pursuing products that address health crises, deliver ‘innovative cures’ or address other unmet public health needs.” While these “health crisis” conditions have not been outlined, it appears to be a goal of the FDA’s new leadership to challenge the current system for products that ultimately receive this designation.
The FDA is formulating the full plan, with additional details likely coming soon, but for now, it appears to me to be a very ambitious goal. Is it an achievable goal? Good question, we’ll have to wait to see how it plays out. We’ll also have to see how the drugs are selected to be awarded a National Priority Voucher. Typically, under the current process, drugs designated for accelerated approval (which are clearly defined) receive a priority-review clock of six months. Shortening this review time to just one to two months and assuring that all disciplines will have time to review the data as well as ask questions of the firm that submitted the application, waiting for the firm to respond, and then reviewing the new data will be a challenge for reviewers and their multidisciplinary teams, not to mention the time needed for the final supervisory review. While it is a lofty goal, it will certainly be an enormous departure from the typical review process.
A new application, especially for a novel new drug or a drug treating a condition for which there is currently no available treatment, represents a lot of new and potentially never-before-seen information and data to be reviewed. A lot of hands in the Agency will have to touch the application, to evaluate and, ultimately, agree to the approval of a new drug product (not to mention a potential Advisory Committee meeting). Those one to two months will come and go rather quickly.
With the number of complete response letters on the rise for standard review applications and the FDA’s reduction in force of support staff and policy people, on top of the time for reviews for safety and efficacy, the reduced resources may dictate the length of time each review and approval will take and whether UFA goals can be met. Considering these factors, along with all of the concerns being voiced by the FDA’s top leadership regarding products either approved or submitted for approval under the current accelerated approval process, I’m not sure how an approval could be realized only one to two months after submission, even with the utmost FDA effort. We’ll just need to wait and see how and whether the program plays out.
