The fine comes after the British heavyweight admitted several criminal charges relating to US marketing laws, by promoting two of its drugs for unapproved use and for failing to report significant safety data about one of its diabetes medications to the Food and Drug Administration (FDA).
The company has also been found guilty of bribing doctors to promote the drugs, by paying for lavish holidays, speaking tours and even tickets to Madonna concerts.
The case involves three of GSK’s well-known drugs. Prosecutors found Paxil had been prescribed to children and adolescents, despite being only approved for adult use in the US. According the NYT, the antidepressant later added warning that it might increase the risk of suicidal thoughts in teenagers.
Wellbutrin, a drug sanctioned only to treat serious depression by the FDA, was found to have been promoted to counteract obesity and impotence.
GSK had also failed to clarify research data and safety risks involving Avandia, a medication that helps control blood sugar levels by making patients more sensitive to their own insulin. Avandia has been heavily restricted since 2010 after it emerged it had strong links with heart problems among users.
The company will have to pay $1bn in criminal fines and $2bn in civil fines and will now be monitored by US authorities for the next five years.
The settlement was called “unprecedented in both size and scope,” by deputy US attorney general James Cole at a press conference in Washington yesterday. “It underscores this Administration’s firm commitment to protecting the American people and holding accountable those who commit health care fraud,” he said.
“At every level, we are determined to stop practices that jeopardise patients’ health; harm taxpayers; and violate the public trust – and this historic action is a clear warning to any company that choose to break the law.”
In a statement released yesterday, GSK’s chief executive Andrew Witty said company procedure involving sales and marketing, and compliance had been changed at their US subsidiary, and he has since overhauled the unit’s operations and replaced several members of staff.
“We have learnt from the mistakes that were made,” he said. “When necessary we have removed employees who have engaged in misconduct. On behalf of GSK, I want to express our regret and reiterate we have learnt from the mistakes that were made.”
