FDA responds to one small piece of Avandia criticism

The FDA yesterday responded to a Forbes op-ed from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published earlier that day. In it, Nissen railed the FDA for revisiting now-restricted diabetes drug Avandia--a drug he and his colleague revealed increased heart attack risk with an independent study in 2007--and alleged that the FDA is doing so absolve itself of responsibility for an error that cost lives. But that's not what the agency took issue with. In its response, the FDA points to a complaint Nissen made about not getting the chance to speak his allotted time during the meeting, stressing that the public has at least a one-hour opportunity to present views and information at every advisory committee meeting. "The FDA encourages participation from all public stakeholders in the open public hearing portions of advisory committee meetings," it noted. Story | More

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