Thursday, July 15, 2010

FDA panel votes to keep Avandia on the market

After years of debate, mountains of data, harsh opinions, corporate intrigue and agency infighting, the FDA advisory committee voted to 20-12 (with one abstention) to keep Avandia on the market, but with either restrictions or labeling changes. The FDA doesn’t have to follow the advice of its panels, but generally does. And so, FDA officials must decided whether to develop a package of caveats that will appease those who maintain Avandia is should remain on the market, despite the cardiovascular risks. This possibility suggests Avandia could remain available elsewhere, although European regulators hold their own review next week. Go to Pharmalot for the full story. I am a little surprised by the vote because even though some reports concluded the FDA was divided on the issue, the "build up" to the meeting was dominated by very negative stories. Here is a sample of some of those: An interview with the former FDA medical reviewer who left the agency three years ago amid controversy over her work on Avandia who had pressed for stiffer warnings on the drug, but was rebuked and excluded from safety meetings. See here. News that GlaxoSmithKline quietly began a study in 1999 to determine if the cardiovascular risks of its Avandia diabetes pill were greater than with Actos, a similar drug, and instead of publishing the results, the drugmaker spent 11 years trying to cover them up, according to Pharmalot and The New York Times. Claims that Glaxo withheld a study from the FDA showing a link to heart attacks. See AboutLawsuits, Bloomberg News, Pharmalot. News that a group of doctors today filed suit against the Food & Drug Administration for failing to alert diabetes patients to safer alternatives to Avandia and other diabetes drugs that may increase the risk of stroke, heart attack and death. See Blog of the Legal Times and News that India has suspended Avandia clinical trials over risks.

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