Recall Avandia? "Keep an open mind," says one FDA commissioner

A Food and Drug Administration commissioner said today that regulators considering a recall of GlaxoSmithKline's diabetes pill Avandia should "keep an open mind," Bloomberg News reports.

Margaret Hamburg made her comments during the first day of a two-day FDA advisory panel meeting on Avandia being held in suburban Washington.

"Follow the science, wherever it leads, and the rest will fall into place," Hamburg said.

Bloomberg also reported today that GSK has agreed to pay $450 million to settle a majority of the lawsuits, about 10,000, alleging Avandia can cause heart attacks and strokes.

GSK is set to face its first Avandia trial in federal court in October.

At the conclusion of the two-day hearing, the panel is expected to recommend to the FDA whether the drug should be pulled or whether new warnings or restrictions are warranted because of safety concerns.

The panel also could decide to leave Avandia on the market as is. The FDA typically follows the recommendations of its expert panels but isn't bound to do so.

The controversy over Avandia involves two of the Triangle's major employers: London-based GSK has its U.S. headquarters in Research Triangle Park and Durham-based Quintiles worked with GSK on a long-term Avandia safety study that has drawn sharp criticism from regulators and others.

That study is expected to take center stage today and tomorrow during the advisory panel's meeting.

To read more on GSK, Quintiles and Avandia go here.