FDA to GSK: How Widespread Are Your Reporting Deficiences?

More concerning than the delayed results of Merck's and Schering-Plough's ENHANCE study are allegations in a recent FDA letter to GlaxoSmithKline that the company failed to report multiple Avandia (rosiglitazone) postmarketing studies. Lapses in annual, required NDA reporting of this information by GSK date as far back as 2001, according to the letter, and include more than 20 studies. At least 2 of the studies, which were requested by European regulatory agencies, were intended to identify cardiac-related or -aggravating adverse events. (The FDA did acknowledge that information from 10 studies had been reported to the agency by other means.)

The lapses in the reporting of the studies were discovered during an extended FDA inspection last year of GSK's corporate headquarters, in the wake of widespread concerns about the cardiac safety of the oral antidiabetic agent. The FDA letter also charged that GSK "lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted" and concluded, "Absent a clear explanation of the extent and cause of these deficiences 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." GSK markets more than 60 prescription pharmaceuticals, including Flonase (fluticasone), Paxil (paroxetine), and Valtrex (valacyclovir), in the United States.

In a press release today, GSK acknowledged the warning letter and described last year's on-site FDA inspection as "routine." The company also stated that the "observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia...such as the start and progress of clinical trials, and summaries of final data from some clinical trials [emphasis added]." GSK stressed that the FDA inspection did not result in any citations, despite the fact that the FDA letter threatened "seizure and/or injunction" and the holdup of any pending NDAs or export certificates if the reporting deficiences weren't corrected in a timely manner.

Hat tip to Pharmalot.