PATIENTS AT RISK | Avandia | FDA approval | GSK

NATIONAL – According to TIME (8/12, Park) reports that the FDA panel’s recent decision to recommend keeping Avandia (rosiglitazone) on the market is “a move worth billions of dollars to GSK but that also may have put millions of patients at risk.” The move is also an example “of the drug industry’s outmaneuvering FDA regulators,” which is “disturbingly common, say both scientists and policymakers who follow drug approval and safety monitoring.” FDA critics and industry monitors “charge that the drug-approval process is too easy for pharmaceutical companies to game. It is in some ways an unsurprising development. The FDA serves a public insatiably hungry for new medicines. Yet the agency does not have responsibility for performing safety testing.”

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