Global
healthcare and pharmaceuticals company, GlaxoSmithKline (GSK) has pleaded
guilty to promoting two drugs for unapproved uses and also failing to report safety
data about a diabetes drug to the United States Food and Drug Administration
(FDA).
The case
concerns the drugs Paxil (paroxetine), an antidepressant; Wellbutrin, a typical
antidepressant and smoking cessation aid and Avandia, medication for the treatment
of type II diabetes.
GSK will
pay the sum of $3bn, which includes a $1bn criminal fine and forfeiture and
$2bn to resolve civil settlements with the federal and state governments. This
is the largest healthcare fraud settlement in US history.
Deputy
Attorney General, James Cole, speaking in Washington, DC said that the
settlement was "unprecedented in both size and scope".
"Let
me be clear, we will not tolerate health care fraud," Cole said.
Prosecutors
said that GSK illegally promoted Paxil for treating depression in children from
1998 to 2003, even though it was not approved for anyone under age 18.
The company also promoted Wellbutrin from 1999 through 2003 for weight loss,
sexual dysfunction, substance addictions and attention deficit hyperactivity
disorder, although it was only approved for treatment of major depression.
The
company also conceded charges that it held back data and made unsupported
safety claims over its diabetes drug Avandia.
"The
sales force bribed physicians to prescribe GSK products using every imaginable
form of high-priced entertainment, from Hawaiian vacations to paying doctors
millions of dollars to go on speaking tours, and even 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 to ensure that it complies with marketing and other rules. GSK, in a
statement, said it would pay the fines through existing cash resources.
Andrew
Witty, the chief executive, said procedures for compliance, marketing and
selling had been changed at GSK's US unit.
"We
have learnt from the mistakes that were made. When necessary, we have removed
employees who have engaged in misconduct," Witty said.
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