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FDA Establishes Drug Safety Advisory Board
02/17/2005
Acting-but-soon-to-be-permanent FDA Commissioner Lester Crawford and Health and Human Services (HHS) Secretary Mike Leavitt announced February 15 that FDA is creating an independent Drug Safety Oversight Board (DSB) to supervise management of drug safety issues. The Board is also charged with helping to disseminate emerging pharmaceutical risk and benefit information to healthcare providers and consumers.People want “to know what we know, what we do with information and why we do it,” USA Today quoted Leavitt as saying. He added he supports “a new culture of openness and enhanced independence.” However, The New York Times also reported that according to Crawford, the board will not have independent power to withdraw drugs but will act in an advisory capacity.
FDA officials said the Board, which is part of an overall Agency effort to “enhance the independence of internal deliberations and decisions regarding risk/benefit analyses and consumer safety,” will comprise members from FDA, other HHS agencies and relevant departments, such as the Department of Veterans Affairs. In addition, the Board will consult with outside medical experts and patient and consumer advocates.
Besides establishing the DSB, FDA has pledged to:
- Create a “Drug Watch” web page for emerging data and risk information;
- Increase the use and distribution of “consumer-friendly” Healthcare Professional Information Sheets and Patient Information Sheets for all drugs on FDA’s Drug Watch as well as those with Medication Guides.