May 23,2007

Press Contact:

Sen. Grassley comments on his review of the actions of the Food and Drug Administration with Avandia

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.”

Additional information:

Sen. Grassley has twice introduced comprehensive FDA reform legislation (S.468 in the 110th Congress and S.930 in the 109th Congress) that would give the Office of Surveillance and Epidemiology – the office that monitors drugs once they’re on the market – independent authority to review FDA-approved drugs and determine the need to provide information about newly identified risks associated with these pharmaceuticals. He introduced a modified version of his legislation to strengthen the post-market review function within the FDA by giving the Office of Surveillance and Epidemiology shared authority with the Office of New Drugs on these matters when the Senate considered and approved the FDA Revitalization Act (S.1082) earlier this month. Sen. Grassley’s amendment was defeated by a single vote. As a result, the

Senate version of the FDA proposal that is making its way through the legislative process gives the FDA more authority and power, but it doesn’t specify that it’s for the Office of Surveillance and Epidemiology.

Unless the FDA Commissioner decides to change the way the FDA operates, the Office of New Drugs will continue to be the office that decides when label changes need to be made for new warnings and whether and what studies to require from drug companies after a drug is approved. Under the Senate bill, the Office of Surveillance and Epidemiology will be kept at its current status as a consultant to the Office of New Drugs. More detailed information about Sen. Grassley’s amendment to S.1082 is in a May 9, 2007 news release at the bottom of this document.

Also, the statements made yesterday by Sens. Grassley and Max Baucus about The New England Journal of Medicine article on Avandia, the text of their letters to the FDA and GlaxoSmithKline, the maker of Avandia, and Sen. Grassley’s May 21, 2007 floor statement about Avandia follow here.