The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016

Among 174 new drugs approved from 2012 to 2016, 60% qualified for at least 1 of the FDA’s 4 expedited programs, with breakthrough therapy-designated drugs having the shortest median development time, while drugs receiving only priority review or accelerated approval (without fast-track or breakthrough status) showed no significant difference in development times compared to non-expedited drugs. These findings suggest that the fast-track and breakthrough programs, which are specifically designed to shorten the clinical trial process, are achieving their intended effect, while the other expedited programs primarily accelerate regulatory review rather than overall development.