The agency released a report last week showing that diabetes patients are at a higher risk for heart attacks when they combine Avandia with insulin. The report was released in advance of today’s meeting of an independent advisory committee, made up of outside specialists, which will recommend whether Avandia should carry stronger warning labels or be banned from the U.S. market.
More than 6 million people worldwide have taken Avandia since GlaxoSmithKline introduced the drug in 1999, making it one of the most popular diabetes medications. Sales last year reached $3.4 billion.
The committee was called to meet after a report was released in May that said Avandia put diabetes patients at a 43 percent greater risk of heart attack.
The release of the agency’s findings last week adds pressure to the advisory committee.
“From the get-go, FDA staffers saw trouble with Avandia. If the independent advisory committee members also see dangers, it will be important for diabetic patients to consider, and it will be further evidence that there are serious problems with FDA management style. A kick in the pants from the advisory committee could help force FDA management to pay more attention to their professional scientists,” said Bill Vaughn, a policy analyst with Consumers Union.
The agency is not required to follow the recommendations of the advisory panel, but it rarely dismisses them.
Nancy Pekarek, a spokeswoman for GlaxoSmithKline, said the British company stands by the safety of its drug.
“Our view is that the sum of the data that we have available shows no increase in cardiovascular deaths and does not support a difference in heart-attack risk between Avandia and other common oral anti-diabetic medications,” she said.
“We look forward to the opportunity to present our data [today]. An expert forum is the place to discuss this complex science,” Ms. Pekarek added.
Regardless of the committee’s decision, the agency’s report is likely to spur civil litigation, observers say. Sales of Avandia dropped 31 percent to $226 million in the second quarter, the drug maker said last week, as safety concerns continue to emerge.
Mr. Vaughn’s reference to FDA’s “management style” stems from accusations by a former agency drug-safety supervisor who resigned after a recommendation to place a sterner warning, called a “black box,” on the drug’s label.
Rosemary Johann-Liang, deputy director of the division of drug-risk evaluation at the FDA, reportedly left the agency in frustration this year after being verbally criticized for signing off on the recommendation to place a heightened warning on Avandia for congestive heart failure.
Adding to the controversy surrounding Avandia, senators from the committee with partial oversight over the FDA released a letter claiming a second FDA official was reprimanded for expressing concern over the safety of the drug.
“A senior medical officer in the Office of New Drugs, who at one point was the primary reviewer for Avandia, told staff investigators that she or he was told to stop participation in the review of potential cardiovascular safety problems with Avandia,” said Sens. Charles E. Grassley, Iowa Republican, and Max Baucus, Montana Democrat and chairman of the Senate Finance Committee.
Mr. Baucus and Mr. Grassley said they expect FDA Commissioner Andrew von Eschenbach to respond to their concerns by today, in time for the advisory committee meeting.