The importance of timely PDUFA and BsUFA reauthorization

Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and Commerce Subcommittee on Health discussing the user fee programs which are under consideration by policymakers for reauthorization this year. This follows the U.S. Department of Health and Human Services’ transmittal of the proposed Prescription Drug User Fee Act (PDUFA) VII and Biosimilar User Fee Act (BsUFA) III packages to Congress last month. The beginning of the legislative phase marks an important milestone in the reauthorization process of these two user fee programs.