Panel Discussion

Background: The FDA’s post-marketing (PM) drug safety system is undergoing significant and far reaching enhancements including efforts to advance the science of drug safety, increase resources, and improve processes for PM surveillance. Objectives: FDA will share with the scientific community the evolving role of pharmacoepidemiology in PM drug safety including efforts to increase collaboration with federal and non-federal researchers, access to health care databases, and opportunities for risk evaluation and management of drug safety. Description: Senior Scientists and Epidemiologists from the Food and Drug Administration, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Department of Defense and Department of Veterans Health Administration will describe data systems and programs for surveillance and evaluation of safety, quality and effectiveness of marketed medical products. Additionally, new initiatives to modernize and improve postmarket assessments of medical product safety, quality and effectiveness through improved access and health care database research, collaborations across federal agencies as well as with the private sector will be discussed.

Session Objectives: 1.Describe role of pharmaco-epidemiology in postemarket drug safety assessment 2.Discuss federal data systems used for postmarket drug safety studies 3.Describe inter-agency collaborative projects in drug safety