FDA Answers Public's Concerns

APRIL 01, 2005

Plans are under way to develop a new independent Drug Safety Oversight Board to supervise the management of drug safety issues, according to Department of Health and Human Services (HHS) Secretary Mike Leavitt. The board's tasks include overseeing safety issues such as recommending information and updates for placement on the FDA Drug Watch; resolving disagreements over approaches to drug safety issues; evaluating the need for MedGuides; and managing development and implementation of Center for Drug Evaluation and Research drug safety policies.

The board will include members from the FDA and medical experts from other HHS agencies and government departments. The board also will consult with outside medical experts and representatives of patient and consumer groups. Furthermore, the FDA will initiate a new Drug Watch Web page and share tailored drug safety information sheets with health care professionals and consumer groups.

"The public has spoken, and they want more oversight and openness," said Leavitt. "They want to know what we know, what we do with the information, and why we do it. We will address their concerns by cultivating openness and enhanced independence."



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