Breakthrough Therapy Designation: Bringing Innovation Swiftly to Patients

In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate. The bills received bipartisan support and were included as an amendment to the Food and Drug Administration Safety and Innovation Act in the Prescription Drug User Fee Act V. On July 9, 2012, the breakthrough therapy designation was signed into law. As of June 13, 2014, a total of 48 products have been designated as breakthrough therapies by the Center for Drug Evaluation and Research, and 4 of those have received FDA new molecular entity approval.