FDA plans new board to monitor drug safety, inform consumers

02/16/2005 | Washington Post, The · NYTimes.com

The move comes on the heels of congressional criticism of the FDA's oversight of drug safety and arrives on the eve of public hearings by an agency advisory panel to review concerns associated with Celebrex, Bextra and Vioxx. Michael Leavitt, secretary of the U.S. Department of Health and Human Services, said the new advisory board is "a response to a widely held concern both inside and outside Congress." The board would not have authority to withdraw drugs from the market but would advise the agency and post information for consumers on a Web site. Critics argue the new board as proposed does not go far enough, is made up of federal officials and is not an independent body. A longtime proponent of an independent review board, Dr. Alastair Wood of Vanderbilt University, asserted, "It's a huge opportunity that's been lost to introduce transparency and restore confidence in the system."

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