3 Jul 2012

GlaxoSmithKline fined $US3b

7:01 am on 3 July 2012

GlaxoSmithKline is to pay $US3 billion in the largest healthcare fraud settlement in United States history.

The giant drug company is to plead guilty to promoting two drugs for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration.

The BBC reports the settlement will cover criminal fines as well as civil settlements with the federal and state governments.

The case concerns the Paxil and Wellbutrin antidepressants and Avandia, a diabetes drug.

Deputy US Attorney General James Cole said the settlement was unprecedented in both size and scope.

GSK admitted promoting Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents. The practice is known as off-label marketing.

The company also conceded charges that it held back data and made unsupported safety claims over Avandia.

In addition, GSK has been found guilty of paying kickbacks to doctors.

As part of the settlement, GSK agreed to be monitored by federal government officials for five years.

GSK said in a statement it would pay the fines through existing cash resources.