FDA says Glaxo failed to report Avandia data

GlaxoSmithKline Plc failed to report some post-marketing data on its diabetes drug Avandia, the U.S. Food and Drug Administration said in a warning to the company released on Tuesday.

An FDA letter said an inspection conducted last year found the company did not include multiple post-approval studies as required in periodic and annual reports about the drug, which has faced intense scrutiny for safety concerns.

“The specific violations in this letter are serious and may be symptomatic of underlying postmarketing safety reporting failures,” the FDA said in the letter, which was dated March 25 and posted on the agency’s Web site on Tuesday.

GlaxoSmithKline spokeswoman Nancy Pekarek said the omissions were “inadvertent” and the information was provided to the FDA before officials decided the drug needed a strong “black box” warning saying it might increase the risk of heart attacks. The agency announced in November 2007 that Avandia could stay on the market with the new warning.

Glaxo Chief Medical Officer Ronald Krall said in a statement that the reporting omissions “did not interfere with the timely reporting of adverse event information to the FDA.”

Some of the information was disclosed to the FDA in other ways, the FDA and Glaxo said.

The British drugmaker also said it was providing additional training to employees on reporting requirements and taking other steps to address the FDA concerns.