Six weeks after a 20% reduction in force at the FDA removed thousands of drug, device, and food reviewers and inspectors, signs are emerging that the agency’s approach to evaluating new drugs will change. Some industry leaders have expressed concern that the new leadership of Commissioner Makary and physician Vinay Prasad could impact the speed of approvals. Several vaccine makers saw their shares fall on news that Prasad would lead the Center for Biologics Evaluation and Research, which regulates vaccines, blood products, and cell and gene therapies.
In the past, he has been a vocal critic of accelerated approval pathways and mRNA vaccines. He has also been critical of the FDA’s oversight of confirmatory trials, a requirement for all drugs approved using the accelerated pathway. The need for confirmatory trials is especially important for drugs approved based on surrogate endpoints, like cancer medications Clolar (clofarabine) and Xydelig (idelalisib), which were granted accelerated approval and required to undergo follow-up studies, but which ultimately failed to demonstrate the anticipated clinical benefit.
Other changes to the agency’s policymaking could impact drug approval timelines, particularly for generic manufacturers who must wait until patent exclusivity expires on a brand-name medicine before filing an Abbreviated New Drug Application for a copy. Tenbarge notes that a lack of formal guidance documents, and even informal meetings with the agency, could delay the processing of applications for generic drugs. This could increase the time it takes for generic manufacturers to complete their clinical studies needed to support their submissions and delay patients’ access to lower-cost treatments.