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May 25, 2007

FDA scrutinized for lack of power amid new warnings on diabetes drug

Troubling questions about the safety of a widely used diabetes medication have given more ammunition to Democrats seeking tougher drug-safety legislation. Key House Democrats and their staff were still digesting the disclosure on Monday that GlaxoSmithKline’s Avandia may be associated with a significantly increased likelihood of heart attacks and other fatal cardiovascular side effects. The news plays into the hands of lawmakers and consumer advocates who contend that the FDA lacks the authority to ensure that drugs already on the market are safe. Some of these critics say the pending bill does not go far enough to address the agency’s shortcomings. Closed-door negotiations among the Democratic members of the House Energy and Commerce Committee on the FDA bill have been taking place for months. The panel already has convened a series of hearings on the FDA and the safety of prescription drugs and medical devices, and it is expected to begin marking up the bill soon after the House returns from Memorial Day recess.

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