FDA: Glaxo Failed To Report Avandia Studies

The agency sent the drugmaker a harsh warning letter for failing to include nine Avandia post-marketing studies - seven clinical trials and two observational trials - in mandatory periodic and annual reports that are supposed to include a wide range of activities and events associated with each and every product. The FDA letter, which was dated March 25 and posted on its web site this morning, indicates the agency found the omissions while inspecting Glaxo offices in Research Triangle Park, North Carolina, between last August and November.

The inspection occurred shortly after an FDA advisory committee meeting in which the panelists recommended stiffer warnings be placed on Avandia about heart attack risks. The debate followed a controversy that erupted last May, when The New England Journal of Medicine published a meta-analysis showing Avandia increased the risk of heart attacks by 43 percent. At a subsequent Senate hearing, Steve Nissen of the Cleveland Clinic, who conducted the analysis, complained that Glaxo was uncooperative when asked to make Avandia data available.

The “FDA’s inspection revealed that your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies notes. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the postmarket reporting for your firm’s other FDA-approved drugs may exist,” Mary Woleske, the FDA’s Atlanta district director wrote to JP Garnier, Glaxo’s ceo.

A Glaxo spokeswoman calls us to say that these were “inadvertent omissions” and that the FDA didn’t find fault with the drugmaker’s regular reporting of adverse events. There were no heart attacks, for instance, in the trials that weren’t reported to the FDA, although she maintains Glaxo would have reported those to the FDA. “Anything that was serious they would have found out about, anyway,” she tells Pharmalot.

“We did take action to get the information to the FDA before they made the label changes (to Avandia). We don’t believe safety was compromised. And we’ve instituted a training program so our staff knows what we’re supposed to report and how we’re supposed to report it. It’s an ongoing effort.” Here is the Glaxo statement that was just issued.