Avandia Debacle Puts FDA on the Spot

The latest <"http://www.yourlawyer.com/topics/overview/avandia">Avandia controversy has put the Food & Drug Administration (FDA) in a rather unfavorable light. According to The Wall Street Journal, the Senate Finance Committee’s Avandia report that we detailed over the weekend is putting pressure on the agency to reform its drug safety program.

As we reported over the weekend, the Senate report found that in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks. The report maintains that some of those could have been avoided if GlaxoSmithKline had considered Avandia’s cardiovascular risks in 1999 when they were first raised. Instead, the report says Glaxo tried to undermine criticism of the drug.

The Senate report also detailed an internal FDA reviews of Avandia conducted by Dr. David Graham and Dr. Kate Gelperin. As we reported previously, Graham is a long-time critic of Avandia, and had argued to an advisory panel in 2007 that Avandia sales should be stopped. According to the Senate report, Graham and Gelperin urged that Avandia be pulled in an internal memo from October 2008. The FDA rejected their recommendations.

In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The warning followed a an analysis of 42 clinical trails published by the Cleveland Clinic showed that patients taking the drug had a 43-percent higher risk of having a heart attack. In addition to the stronger warning, the FDA also ordered Glaxo to compare Avandia’s cardiovascular risk to Actos, another diabetes treatment.

According to the Senate report, Graham and Gelperin both called the study “unethical and exploitative” because patients given Avandia face far greater risks than those given Actos, with no promise of any additional benefit. Despite their concerns, the study, called TIDE, is still enrolling patients.

According to The Wall Street Journal, the FDA is trying to assemble a timeline of what the FDA knew of risks associated with Avandia. The Journal also said agency leaders held calls over the weekend to discuss how to address complaints from Sens. Max Baucus (D., Mont.), chairman of the Finance Committee and Chuck Grassley (R., Iowa), the panel’s leading Republican. The senator’s want to know why the FDA rejected the 2008 recommendation that Avandia be removed from the market.

According to the Journal, publication of the Senate report has also renewed calls by FDA critics for an independent safety unit at the agency to track problems with drugs after they go on the market. Currently, the unit responsible for the post-market surveillance is subordinate to the FDA’s drug approval division, which critics say creates a conflict of interest because personnel responsible for approval are evaluating their own decisions. A former editor of The New England Journal of Medicine told The Wall Street Journal that the authority to ask for a drug to be pulled from the market “should be given to the safety reviewers, not to the Office of New Drugs.”

Such a split has also been promoted by Senator Grassley for several years, according to the Journal.

This entry was posted in Avandia, Pharmaceuticals. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.