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Controversy Spikes Over Anti-diabetes Drug Avandia

inistration's role in its approval in 1999.

The FDA has come under fire for approving Merck's anti-inflammation drug Vioxx, which was taken off the shelves in 2004 after it was linked to increased heart attacks and death.

"By examining Avandia ...

we can learn a lot about the drug approval and the post-market surveillance process," Democratic Representative Henry Waxman, of California, told the hearing.

"Avandia is a case study of the need for reform of the nation's drug safety laws," he added.

The House panel was keen on hearing from Rosemary Johann-Liang, from the FDA Office of Drug Safety, who in an NEJM interview said she had approved in March 2006 a recommendation from FDA inspectors to toughen a warning label on Avandia to stress its increased risk for heart attacks.

Johann-Liang said she was pressured to go back on her decision after FDA officials were contacted by GSK.

FDA Commissioner Andrew von Eschenbach, Nissan, and a GSK representative are expected to testify at the House hearing on Wednesday.


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