Obama signs FDASIA, creating Breakthrough Therapy Designation for expedited drug development

President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) on July 9, 2012, adding the Breakthrough Therapy Designation (BTD) to the FDA's suite of expedited programs. A drug qualifies if preliminary clinical evidence shows it may offer substantial improvement over existing therapy for a serious condition. BTD triggers intensive FDA guidance, rolling review, and a 60-day initial response commitment — compressing development timelines that previously averaged 8–12 years. The designation became one of the FDA's most-used pathways; by 2026, more than 600 drugs had received BTD, with cancer therapies accounting for over half.