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U.S. Department of Health and Human Services

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February 15, 2005

Photo of HHS Secretary Mike Leavitt standing at the podium talks with FDA staff

HHS Photo by Chris Smith

HHS Secretary Mike Leavitt talks with FDA staff after announcing the agency's new Drug Safety Oversight Board in February 2005.

In response to recent concerns about the safety of a number of prescription medicines, the FDA announces the formation of a Drug Safety Oversight Board. The board will oversee the management of drug safety issues, consider decisions about risk-benefit analyses and consumer safety, and provide emerging information to health providers and patients about the risks and benefits of medicines.


FDA in 2006


One very important role of the Drug Safety Oversight Board (DSB) is to expand existing communication channels and establish new ones to communicate more clearly with the public about the FDA's evolving knowledge of drug safety concerns. By December 2005, the FDA's Center for Drug Evaluation and Research (CDER) had posted on its Web site new information for patients and health care professionals on at least 44 different drugs, reflecting issues with 6 product classes, 3 market suspensions, 2 product withdrawals, and 37 warnings added to the product label.




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