Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the Prescription Drug User Fee Act (PDUFA VII) and the Biosimilar User Fee Act (BsUFA III). In February, PhRMA had the opportunity to testify before the subcommittee on how both programs have played, and will continue to play, a significant role in sustaining the U.S. Food and Drug Administration’s (FDA) ability to keep pace with the number of innovative drugs, biologics and biosimilars entering the regulatory review pipeline. In March, PhRMA had an additional opportunity to testify on potential legislative “riders” including those relating to clinical trial diversity, accelerated approval and rare disease drug development. The recent release of the legislative text and today’s subcommittee markup are important milestones in Congress’ review and approval of these critical programs.
