Orrin Hatch: “Senator Kennedy has always been a leader in public health issues and I appreciate the efforts of him and his staff to…”

“Senator Kennedy has always been a leader in public health issues and I appreciate the efforts of him and his staff to address this important matter. However, I am concerned one provision of my amendment that was not included which deals with bioequivalence standards for locally-acting non-absorbed drugs. In the amendment I filed for Committee, I had asked for the Food and Drug Administration to establish a new bioequivalence standard for these drugs through a guidance allowing for transparency and a public process. The underlying bill deals with drug safety and although I am a supporter of the generic drug industry, I want to ensure that their bioequivalence standards are based on science--we need to ensure that FDA is applying high scientific standards and allowing for public input when these standards are developed by the Office of Generic Drugs.”