Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
Today's post was shared by NEJM and comes from www.nejm.org
Many people with serious or life-threatening illnesses for which there are no satisfactory treatments are understandably eager to gain access to new therapies and are willing to trade off greater certainty about a drug's performance for speed of access.
Because the typical clinical drug-development program takes about 7 years, during which a substantial body of safety and efficacy data is generated, the Food and Drug Administration (FDA) has long-standing expedited pathways available for drugs being studied for such illnesses. However, many patients and their advocates continue to believe that clinical development is sometimes prolonged beyond what is necessary.
During the congressional considerations leading up to passage of the FDA Safety and Innovation Act of 2012 (FDASIA), a variety of provisions related to this theme were put on the table.