The Federal Drug Administration (FDA) plays a large and influential role in the health and safety of the American people. FDA is responsible for ensuring that drugs and devices are safe and effective, and that food is uncontaminated and properly labeled. FDA’s regulatory functions are critical to the nation’s economy, and agency failures have significant costs. Since 1994, Congress has enacted 60 laws adding to FDA’s mandated responsibilities, with virtually no new funding. The numbers of drug prescriptions have increased significantly and at the same time, the medical device industry continues to grow. The agency oversees a food supply that is more global than ever before and unprecedented levels of food imports, placing a greater burden on FDA. FDA’s responsibilities have grown rapidly in recent years and are expected to continue to expand. These changes come at the same time that multiple stakeholders have raised concerns about FDA’s resources, scientific integrity, and commitment to vigorous enforcement. A transcript of this hearing is now available.

Tuesday's hearing examined several key facets of FDA’s responsibilities and major concerns and challenges for FDA’s ability to fulfill its important role and restore public confidence.

• Donald Kennedy, Ph.D., former FDA Commissioner (1977-1979)


• Frank Young, M.D., Ph.D., former FDA Commissioner (1984-1989)


• David Kessler, M.D., J.D., former FDA Commissioner (1990-1997)


• Andrew C. von Eschenbach, M.D., FDA Commissioner