Thursday, May 24, 2007

GSK - Avandia: anyone know the FDA's "reviewer with a conscience"?

Back story here.

Iowa Senator Charles Grassley says Avandia was the subject of a major internal battle at the Food & Drug Administration several years ago.

Grassley says the division was between the office that monitors drugs once they are on the market and the office approving new drugs for sale.

The FDA safety surveillance unit wanted sterner warnings, so-called black box warnings, on Avandia's labels, but the unit was overruled by the new drug officers.

Grassley says he has also learned thay one of the FDA's experts on diabetes, whom his staff described as "a reviewer with a conscience," was removed from involvement with Avandia.

Source

Anyone know who?

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