Healthy Skepticism Library item: 11909

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Publication type: news

Dixon K.
U.S. Senator Asks FDA About Internal Avandia Vote
Reuters Health 2007 Oct 29
http://www.therapeuticsdaily.com/news/article.cfm?contentValue=1578364&contentType=sentryarticle&channelID=33

Full text:

A senior Republican lawmaker asked the U.S. Food and Drug Administration to confirm that an internal FDA group privately voted to keep the troubled diabetes drug Avandia on the market by a one-vote margin, according to a letter made public on Monday.

Sen. Charles Grassley, the ranking Republican on the Senate Finance Committee, said committee investigators learned that the FDA’s Drug Safety Oversight Board (DSOB) voted 8-7 on Oct. 2 to keep the GlaxoSmithKline drug on the market.

The FDA set up the internal board in 2005 after a series of controversies, including criticism over the recall of Merck’s painkiller Vioxx, put pressure on the agency to bolster its systems for tracking drug safety.

The board is made up largely of director-level FDA officials and meetings are not open to the public. Meeting summaries are posted on the agency’s Web site, but the last one is dated Aug. 22.

The FDA is considering stronger warnings to Avandia’s label after an agency advisory panel in July voted 22-1 to keep Avandia on the market, even though it may raise heart-attack risks. Most members of that panel also advised the FDA to add new warnings about that risk.

The July meeting was prompted by an analysis published in the New England Journal of Medicine that linked the drug to a 43 percent boost in heart attack risk.

“The Avandia case continues to present new rounds of questions about the way the FDA monitors and assesses drug risks and decides whether to let the public know about emerging risks,” Grassley said in a statement.

“It is my understanding that the DSOB vote took place 24 days ago,” Grassley wrote in the letter dated Oct. 26, addressed to FDA Commissioner Andrew von Eschenbach. “I have yet to see any public notification of this vote.”

An FDA spokeswoman said the agency will respond to Grassley’s letter but would not comment further.

GlaxoSmithKline spokeswoman Nancy Pekarek said the company is still in talks with the FDA and was not aware of any decision by the FDA’s Drug Safety Oversight Board.

Sales of Avandia fell 48 percent in the United States in the most recent quarter from the year-ago period.

TENSION WITHIN AGENCY

One critic of the FDA said the oversight board’s decision on Avandia shows how the agency’s drug review division is more powerful than the FDA’s drug safety arm.

“It’s another demonstration of how dominant the drug review division is,” said Sidney Wolfe, director of consumer group Public Citizen’s health research arm.

The FDA drug review division, which gets much of its funding from user fees paid by drug manufacturers, evaluates new drug applications. The smaller drug safety division reviews potentially dangerous side effects after a drug is approved.

Recommendations of the FDA’s drug oversight board are to be made by a two-thirds majority of an 11-member quorum, according to the FDA Web site. A quorum must include at least two members from the drug safety unit and two from the drug review unit.

But in the end, the final decision is up to the director of the FDA’s drug review office.

Glaxo’s shares were up 59 cents, or 1.2 percent, at $51.11 in afternoon trading on the New York Stock Exchange.