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Avandia controversy stirs Congress to investigate FDA

Remember learning about "checks and balances" in U.S. History class? When state leaders gathered in 1787 to draft the Constitution, they established three branches of government (legislative/executive/judicial) to protect individual freedom and prevent government from abusing its own power. Now, Congress is questioning the balance of powers over at the Food and Drug Administration (FDA).

Republicans and Democrats in the House and Senate have called for an investigation into the FDA in the wake of the New England Journal of Medicine study which suggests the popular diabetes medication, Avandia, significantly increases the risk of heart attacks. A House hearing is set for June 6.

Original trials by the drug's maker, GlaxoSmithKline, revealed twice the rate of ischemic heart disease for patients taking Avandia versus recipients of placebos. The medical reviewer for the FDA initially expressed concern, but determined the risk was more benign following further analysis.

Internally, the FDA has one set of officials who approve drugs and another set who track the safety of drugs after approval. But there is an unequal balance of power between the safety and approval offices. Congressional investigators report the safety group recommended months ago Avandia receive its severest warning. The review group disagreed. Here's the catch -- the reviewers hold more power than the safety officials.

Senator Charles E. Grassley, Republican of Iowa and others in Congress have pushed for a separation of the approval and safety offices, and increased power for the safety group. Just this month, Senator Grassley proposed such a split, but it failed by one vote. House staffers believe the Avandia case re-ignites Senator Grassley's proposal as the House is soon entering debates to change the drug agency. Here is a previous post covering the Avandia concerns and the full story on the FDA.

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