The study on Fast Track and Breakthrough Therapy Designations by the U.S. FDA for New Drugs

Expedited programs have emerged to support the development of drugs that treat serious conditions or address unmet medical needs. This study examined trends in Fast track and Breakthrough Therapy designations by the U.S. Food and Drug Administration (FDA) for new drugs approved from 2013 to 2022. Using publicly available data from the FDA’s Center for Drug Evaluation and Research New Drug Therapy Approvals Reports and the Drugs@FDA database, we investigated the number of new drugs with these designations, their overlap with Priority Review status, and the time to approval. Among 428 new drugs approved during the study period, 155 received Fast Track and 122 received Breakthrough Therapy designations. Over 90% of drugs with either designation were also granted Priority Review, showing a statistically significant association between these expedited programs and Priority Review status (Fast Track: p=1.31×10 17; Breakthrough Therapy: p=2.28×1022). The time to approval for Fast Track and Breakthrough Therapy drugs was approximately 8.0 months, comparable to the estimated approval time for Priority Review drugs. These findings suggest that while these designations are strongly linked to Priority Review, they may not significantly shorten time to approval beyond that provided by Priority Review alone. Increased transparency regarding the FDA’s rationale for granting or denying expedited designations would help facilitate the development of future therapies.