GSK Gets Warning Letter on Avandia Trials

GlaxoSmithKline has received a warning letter from the FDA related to reporting requirements for approved medicines. The letter follows a routine inspection of the company’s 2007 reporting processes.
   
The inspection revealed omissions from periodic reports to the FDA regarding its diabetes drug Avandia, such as the start and progress of clinical trials, and summaries of final data from some clinical trials. The inspection also reviewed the company’s processes for reporting individual adverse events, which resulted in no inspection citations.
   
“We take these findings seriously, and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway,” said Dr. Ronald Krall, chief medical officer at GlaxoSmithKline, who stressed that the omissions did not interfere with the timely reporting of adverse event information to the FDA.
   
The FDA began inspecting GSK’s records in August to see if the company was reporting all Avandia data in full. It found that between 2001 and 2007, the company failed to report the initiation of nine clinical studies, and failed to update the FDA about the progress of more than 12 other studies. After the inspection, the company initiated a review of applicable processes and reporting systems. GSK is now updating its procedures in an effort to improve compliance in this area of reporting.
   
Concerns about the drug arose last year when a study showed that patients taking Avandia had a higher risk of suffering a heart attack than those taking other oral diabetes medicines or placebo pills. In November, GSK added a warning to Avandia’s label describing the study’s findings.