The DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, advises the CDER Center Director on the handling and communicating of important and often emerging drug safety issues. The DSB meets on an ad-hoc basis and provides a forum for discussion and input about how to address potential drug safety issues.
The DSB is composed of representatives from three FDA Centers and eight other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Centers for Medicare and Medicaid Services (CMS), Department of Defense (DOD), Bureau of Prisons (BOP), Indian Health Service (IHS), National Institute of Health, Clinical Center (NIH/CC), and Department of Veterans Affairs (VA). An important role of the DSB is to help FDA assess the impact of their safety decisions on the healthcare systems of its Federal Partners. The Board, with its broad representation from federal healthcare organizations, can provide valuable input and allows FDA to hear other perspectives on drug safety issues.