GlaxoSmithKline (GSK) tells in-Pharmatechnologist.com that it was 'mistakes' made a decade ago that led to this week's $3bn worth of criminal charges.
The UK-based pharma giant made US history when it paid the largest healthcare fraud settlement ever for illegal activities over 10 drug products, pleading guilty to charges including hiding vital safety data from the FDA (US Food and Drugs Administration), marketing its therapies for unapproved uses, and embezzling money from Government funds.
A spokesperson for the firm told in-PharmaTechnologist.com that the case dates back years and that GSK now has its act together.
“This settlement relates specifically to sales and marketing practices in the US and matters that occurred almost a decade ago” he said, adding that “However we must acknowledge what happened and learn from our mistakes.
“Since Andrew Witty became CEO in 2008, GSK has made significant changes at all levels within the company to ensure we act with integrity in everything we do and these matters do not reflect the company that we are today.”
In a statement, Witty also spoke about the actions put in place in the US to correct the mistakes and to prevent more since he became head.
“We have fundamentally changed our procedures for compliance, marketing and selling,” he said. “When necessary, we have removed employees who have engaged in misconduct. In the last two years, we have reformed the basis on which we pay our sales representatives and we have enhanced our ability to ‘claw back’ remuneration of our senior management.”
During this week’s hearing, the firm admitted failing to report seven years’ worth of safety problems with diabetes drug Avandia, which was banned in the EU in 2007 after it was found to increase the risk of heart attacks.
It pleaded guilty to the illegal promotion of Paxil and Wellbutrin – normally therapies for nervous disorders antidepressants in adults – for uses not approved by the US FDA (Food and Drug Administration), including use in children.
Paxil in particular was found to cause suicidal tendencies in child populations.
It also bowed to accusations of appropriating extra money from the government-funded Medicaid, as well as bribing doctors to prescribe some of its medications, including Flovent for asthma and Valtrex for genital herpes.
Problems were first flagged up in 2001 when whistle blower Greg Thorpe sparked internal investigations within the group. However inquiries reportedly led to the former sales representative’s dismissal, rather than any changes.
During the proceedings, US Deputy Attorney General James Cole said: "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 chooses to break the law."