Acting FDA Chief: User Fees, ‘Cures’ Discussions Must Inform Each Other

Acting FDA Commissioner Stephen Ostroff told the agency’s Science Board that user fee negotiations cannot occur in isolation from the ongoing debate surrounding the House-passed 21st Century Cures bill and the Senate’s complimentary medical innovation effort, saying the congressional initiatives directly impinge upon user fee talks. A top FDA policy official also flagged certain provisions of the Cures bill that continue to be a source of concern for the agency, including the biomarker validation provisions, which he warns could pose...