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FDA receives letter from Sen. Grassley questioning Avandia decision

10/31/2007

WASHINGTON Senate Finance Committee Ranking Member Chuck Grassley, R-Iowa, is questioning the Food and Drug Administration about an alleged vote by its Drug Safety Oversight Board to keep GlaxoSmithKline’s Type 2 diabetes drug Avandia on the market.

Committee investigators learned the FDA convened its DSOB Oct. 2 and the board voted 8 to 7 to keep Avandia on the market, Grassley wrote in a letter to FDA Commissioner Andrew von Eschenbach. However, he said, the FDA has not notified the public of the vote.

Grassley is requesting information on the FDA’s internal policies and procedures regulating the DSOB and stipulating when information from the board can be released to the public.

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