FDA Panel: Keep Avandia on Market
Recommendation Made Despite Concerns That Diabetes Drug Boosts Heart Attack Risk
Still, there appeared to be significant disagreement within the FDA's
leadership about whether Avandia should remain on the market. Gerald Dal
Pan, MD, the director of the agency's office of surveillance and epidemiology,
announced that he agreed that Avandia should no longer be sold.
It is highly unusual for a senior FDA official to offer an opinion about a
drug's future during expert deliberations. Dal Pan said his statement reflected
"a personal recommendation," and not an official agency position.
But Robert Meyer, MD, director of the FDA's office of new drug evaluation,
said there was "significant disagreement" among regulators over whether
they had enough evidence to act against the drug.
Krall said in a later statement that GlaxoSmithKline was pleased with
Monday's vote. "The committee recognized the debilitating nature of this
disease ad the importance of multiple treatment option."
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