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FDA's new drug safety board under scrutiny.(Practice Trends)
Many questions surround the authority of a new drug safety board that would oversee the management of drug safety and provide emerging information to physicians and patients about the benefits and risks of medicines on the market.
Such a board is one of several steps that Health and Human Services Secretary Mike Leavitt is taking to improve oversight and "openness" at the Food and Drug Administration.
"Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to U.S. consumers," said acting FDA Commissioner Lester Crawford, D.V.M., Ph.D.
The drug safety board is being touted as an independent entity, yet lawmakers and consumer groups have questioned how much independence or authority the board will actually have.
Larry Sasich, a pharmacist and research analyst for Public Citizen, noted that recommendations and concerns of the FDA's current Office of Drug Safety, which is a subunit of the Office of New Drugs, are often ignored by the agency's new drug reviewers.
If the new board reports in a similar manner, "it may be a stretch to call it an independent board," Mr. Sasich said.
Secretary Leavitt said that the new board would resolve disagreements over approaches to drug safety issues, oversee development and implementation of center-wide drug safety policies, and assess the need for MedGuides.
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