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GlaxoSmithKline to pay record $3 billion in US drug fraud case news
03 July 2012

GlaxoSmithKline plc (GSK) will pay a record $3 billion to various health authorities in the US in the largest healthcare fraud settlement in US history.

GSK on Monday said it has reached an agreement with the US government, several states and the district of Columbia to conclude ongoing federal government investigations. 

The final settlement followed agreements reached during negotiations in November 2011, GSK said in a release. 

Under the deal, GSK will make payments totalling $3 billion, which will be funded through provisioning and additional cash payment of around $180 million, the company said.

The drug giant will plead guilty to promoting two drugs - Avandia and Advair - for unapproved uses and failing to report safety data about a diabetes drug to the Food and Drug Administration (FDA).

The case concerns nine drugs, including Paxil, Wellbutrin, Avandia and Advair.

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

As part of the agreement, GSK has also entered into a corporate integrity agreement with the office of inspector general of the US Department of Health and Human Services. 

The agreement will also cover a portion of GSK's manufacturing operations, related to the company's settlement in 2010 on events in the early 2000s at GSK's former manufacturing facility in Cidra, Puerto Rico, the company said. 

GSK, one of the world's largest healthcare and pharmaceuticals companies, admitted to promoting antidepressants Paxil and Wellbutrin for unapproved uses, including treatment of children and adolescents.

The company conceded charges of holding back data and making unsupported safety claims over its diabetes drug Avandia.

It also agreed to resolve civil liability for promoting asthma drug Advair and two lesser-known drugs for unapproved uses.

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

"The sales force bribed physicians to prescribe GSK products using every imaginable form of high-priced entertainment, from Hawaiian vacations, and paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts," said US attorney Carmin Ortiz.

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

''Today brings to resolution difficult, long-standing matters for GSK. Whilst these originate in a different era for the company, they cannot and will not be ignored. On behalf of GSK, I want to express our regret and reiterate that we have learnt from the mistakes that were made,'' said Sir Andrew Witty, CEO of GlaxoSmithKline plc.

GSK said since most of the amount is provided for, the net effect of these movements on total earnings is expected to be neutral.





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GlaxoSmithKline to pay record $3 billion in US drug fraud case