Drug Safety Oversight Board

The DSB, created in 2005 and mandated by law in the FDA Amendments Act of 2007, provides a forum for discussion and input about how to address potential drug safety issues. The DSB also advises the CDER Center Director on the communication of these important and often emerging drug safety issues. The Board meets monthly and is composed of representatives from three FDA Centers and other government agencies.

In September 2009, the Indian Health Service joined the Drug Safety Oversight Board as a new member of the Board. The Board also has representatives from five other federal government agencies, the Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Department of Defense (DOD), National Institutes of Health (NIH), and Department of Veterans Affairs (VA).

The IHS provides healthcare to 1.9 million of the estimated 3.3 million Native Americans from 562 federally recognized tribes; provides knowledge of the Indian healthcare system; and brings a wealth of patient care information, data, and experience to FDA's Drug Safety Oversight Board. The IHS plans to join the Department of Defense, Department of Veterans Affairs, and FDA in a drug risk communication sharing Memorandum of Understanding sometime in the Fall of 2009.