Healthy Skepticism Library item: 13477

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Publication type: news

GSK warned by FDA
PMLive.com 2008 Apr 9
http://www.pmlive.com/index.cfm?showArticle=1&ArticleID=6622

Full text:

GlaxoSmithKline (GSK) has been issued with a warning letter from the US Food and Drugs Administration (FDA) after an investigation revealed that clinical trial data had been omitted from reports.

The FDA conducted an inspection of GSK’s reporting process in 2007 and discovered that data relating to the start and progress of clinical trials into Avandia (rosiglitazone maleate) had been left out of periodic reports.

However, according to GSK, the FDA did not cite or find any problems with the company’s process for informing the agency about adverse drug side effects.

Dr Ronald Krall, chief medical officer at GSK, said: “These omissions did not interfere with the timely reporting of adverse event information to the FDA.”

“We take these findings seriously and corrective steps to make sure we file periodic reports completely and promptly have been taken or are underway,” he added.

Avandia, indicated for use in patients with type-2 diabetes, has already been subject to controversy after serious side effects related to the drug were revealed. In June 2007 the New England Journal of Medicine reported that the use of Avandia was, in some patients, linked with heart failure or other cardiovascular problems.

The warning letter sent to GSK by the FDA highlighted issues and problems with the periodic reporting process.

Philip Thomson, spokesman for GSK, said: “They [the FDA] essentially found that there were omissions in some of the periodic reports that the company has provided to the agency.”

“The omissions were inadvertent – they certainly weren’t deliberate. I think basically that it is a failure of reporting process,” he added.

GSK has said that it will now remedy any problems with the reporting process to prevent future omissions of data and keep in line with FDA policy. The company has initiated a review of the reporting processes and systems.

Thomson said: “We’ve actually updated some of those processes and we’ve also put in place extra training for staff who are operating that reporting process.”