OFFICIALS LEGISLATION INTEREST GROUPS PUBLIC STATEMENTS COMMITTEES VETOES

Avandia and the FDA

Statement

Date: May 22, 2007
Location: Washington, DC
Issues: Drugs

U.S. Sen. Chuck Grassley today made the statement below about his review of the actions of the Food and Drug Administration with Avandia, a popular diabetes drug.

Sen. Grassley's statement:

"Current and former FDA employees have confirmed for my staff investigators that when it came to concerns about congestive heart failure with Avandia, there was a clear difference of opinion between the office that approves drugs and the office that monitors the drugs once they're on the market. The office that's responsible for surveillance of drugs recommended a
black-box warning, which provides the highest level, strongest warning to doctors and their patients. The FDA didn't take that advice. Instead the warning about congestive heart failure risks with this drug is currently buried on line 351 of the label.

"I've also learned that at least one of the FDA's experts on diabetes, who was described as a ‘reviewer with a conscience,' was removed from involvement with Avandia. This raises questions that I intend to keep asking until there are answers."

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