GlaxoSmithKline Confirms Receipt of FDA Letter on Regulatory Reporting

GlaxoSmithKline today confirmed it has received a warning letter from the US Food and Drug Administration (FDA) related to reporting requirements for approved medicines. The letter follows a routine FDA inspection of GSK's reporting processes conducted last year.

The observations from the inspection primarily relate to omissions from periodic reports to the FDA regarding Avandia(R) (rosiglitazone maleate), such as the start and progress of clinical trials, and summaries of final data from some clinical trials.

The FDA inspection also reviewed GSK's processes for reporting individual adverse events, which resulted in no inspection citations. The inspection found nothing to suggest that procedures for prompt reporting of adverse events was compromised.

"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. "These omissions did not interfere with the timely reporting of adverse event information to the FDA."

GSK is committed to taking the appropriate steps to address the concerns raised by the FDA.

After the inspection, GSK initiated a review of applicable processes and reporting systems. The company has made and will continue progress in updating its procedures and improving compliance in this area of reporting, including additional training for employees to ensure that all procedures are followed across all product lines.

The FDA letter acknowledges that information not captured in the periodic reports was, in many cases, submitted to the Agency in other reports and communications. Beyond that, information about the start of clinical trials omitted from some reports was available through posting on clinicaltrials.gov. GSK submitted a corrected 2007 Avandia annual report to the FDA in September 2007, ahead of the FDA's updated final decision on approved labeling for Avandia in November 2007. Clinical trial results are also posted publicly to GSK's clinical trial register.