The accelerated approval pathway: Helping patients with serious or life-threatening diseases

Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing comes at the same time members of Congress are considering the reauthorization of the user fee programs, the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). The U.S. Department of Health and Human Services’ transmittal of the proposed PDUFA VII and BsUFA III packages to Congress in January marked the beginning of the legislative phase and an important milestone in the reauthorization process of these two user fee programs.