Representing the highest healthcare fraud settlement in US history, GlaxoSmithKline (GSK) has agreed to pay $3bn (£1.9bn) for promoting a number of drugs in the US off-label.
The UK drug maker is to plead guilty for promoting antidepressants, Paxil and Wellbutrin, for unapproved uses, which includes the treatment of children.
GSK will also concede charges for withholding safety data and making unsupported safety claims concerning its diabetes drug Avandia.
The $3bn fine covers both criminal charges and civil settlements.
US deputy attorney general said at news conference in Washington that: “Today’s multibillion-dollar settlement is unprecedented in both scope and size. It underscores this administration’s firm commitment to protecting the American people and holding accountable those who commit healthcare fraud.”
The company has also been charged with paying kickbacks to doctors.
“The salesforce 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.
In a statement, GSK’s chief executive Andrew Witty has said: “Today brings to a 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.”
As part of the settlement agreement, GSK will be monitored by the US government for five years.