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Senator calls for independent drug safety office for FDA
Ambulatory Surgery Reimbursement Update, March 17, 2005
A top Senate Republican plans to put forth legislation that would create an independent drug safety office for the U.S. Food and Drug Administration (FDA), according to Reuters.
The office would have the authority to order the suspension of television ads for drugs while their potential side effects are under investigation. The office would also be empowered to order warning labels on dangerous medicines.
Senate Finance Committee Chairman Charles Grassley said he was impelled to draft the legislation following such recent drug controversies as the withdrawal of the Vioxx arthritis pill.
"We need reforms, both administrative and legislative, to bring greater responsiveness and transparency to the FDA," Grassley said, during a recent speech at a Consumer Federation of America conference.
The FDA's monitoring practices have come under scrutiny following recent reports of two agency scientists saying warnings issued about drug dangers were ignored.
The FDA announced the creation of a drug safety board last month, as reported in the February 22 edition of Ambulatory Surgery Regulatory Update. However, Grassley contends that the board does not have enough independence from the Office of New Drugs, which approves medicines.
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