Oral

The Institute of Medicine recommends a “Health in all Policies” philosophy of regulation. With this in mind, this session examines the strategies of the Food and Drug Administration (FDA) in assuring transparency and accountability in its approval process and discusses the limitations of advisory boards in providing recommendations. The unintentional effects of medical device misclassification and recall by the FDA are explored. The impact of pharmaceutical marketing on health care is addressed. Are these current policies and practices effective in promoting the public’s health?

Session Objectives: • Compare FDA standards of safety and effectiveness for prescription drugs and medical devices. • • Identify implications for patients’ health and healthcare costs of the lack of clinical trials and other weak criteria for FDA approval for many heart valves, joint implants, glucose test strips, and other diagnostic and implanted medical devices. • • Identify public health implications of standards of safety and efficacy of high-risk medical devices, including potentially life-saving or life-threatening devices.