"The settlement ends a seven-year investigation into Glaxo's mis-promotion of medicines in the US, which is the company's largest research centre after Britain and home to almost a fifth of its 100,000 employees. Glaxo warned shareholders last November that it had put aside more than £2bn to pay for the settlement. "
http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/9371404/US-fines-Glaxo-record-3bn-for-mis-promoting-drugs.html
US fines Glaxo record $3bn for mis-promoting drugs
GlaxoSmithKline paid for American psychiatrists to enjoy luxury weekends in Hawaii as it illegally sought to persuade them to prescribe an anti-depressant drug for children, US authorities alleged, as they handed the UK drugs company fines totalling a record $3bn (£1.9bn).
In 2000 and 2001, Glaxo's sales staff regularly held forums to discuss Paxil in destinations including Hawaii and Puerto Rico, where the psychiatrists attending were treated to golf, deep-sea fishing and balloon rides, according to the Department of Justice. Photo: Getty By Richard Blackden, US business editor
8:54PM BST 02 Jul 2012
The historic penalty came as Britain's biggest drugmaker admitted to mis-promoting two medicines, Paxil and Wellbutrin, in the US between 1998 and 2003. The settlement also saw Glaxo admit that it failed properly to report all the necessary safety data to US regulators concerning Avandia, a diabetes drug, between 2001 and 2007.
The settlement ends a seven-year investigation into Glaxo's mis-promotion of medicines in the US, which is the company's largest research centre after Britain and home to almost a fifth of its 100,000 employees. Glaxo warned shareholders last November that it had put aside more than £2bn to pay for the settlement.
"We are determined to stop practices that jeopardise patients' health, harm taxpayers and violate public law," said James Cole, US deputy attorney general.
Glaxo admitted promoting Paxil, an anti-depressant, to patients under 18 even though it did not have permission from the Food and Drug Administration (FDA) to do so.
In 2000 and 2001, Glaxo's sales staff regularly held forums to discuss Paxil in destinations including Hawaii and Puerto Rico, where the psychiatrists attending were treated to golf, deep-sea fishing and balloon rides, according to the Department of Justice.
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Unlike drug companies, doctors are allowed to prescribe medicines for uses that do not have approval by the FDA. According to the US government's lawsuit, one psychiatrist said that "the style of conference would have been more suitable for a convention of sales reps; this is supposed to be a scientific meeting. To me, the music lights, videos and MCs are off-putting and a distraction (even demeaning)."
Glaxo said yesterday that it has changed the way its sales staff are paid by eliminating individual sales targets and aligning their compensation more closely to the quality of treatment a patient receives.
The settlement "brings to a resolution difficult, long-standing matters for GSK", Sir Andrew Witty, Glaxo's chief executive, said. "I want to express our regret and reiterate that we have learned from the mistakes we made."
Glaxo will pay a $1bn criminal fine, with the rest settling civil liabilities. A portion will also go to whistleblowers who originally warned of the mis-promotion
http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/9371404/US-fines-Glaxo-record-3bn-for-mis-promoting-drugs.html
US fines Glaxo record $3bn for mis-promoting drugs
GlaxoSmithKline paid for American psychiatrists to enjoy luxury weekends in Hawaii as it illegally sought to persuade them to prescribe an anti-depressant drug for children, US authorities alleged, as they handed the UK drugs company fines totalling a record $3bn (£1.9bn).
In 2000 and 2001, Glaxo's sales staff regularly held forums to discuss Paxil in destinations including Hawaii and Puerto Rico, where the psychiatrists attending were treated to golf, deep-sea fishing and balloon rides, according to the Department of Justice. Photo: Getty By Richard Blackden, US business editor
8:54PM BST 02 Jul 2012
The historic penalty came as Britain's biggest drugmaker admitted to mis-promoting two medicines, Paxil and Wellbutrin, in the US between 1998 and 2003. The settlement also saw Glaxo admit that it failed properly to report all the necessary safety data to US regulators concerning Avandia, a diabetes drug, between 2001 and 2007.
The settlement ends a seven-year investigation into Glaxo's mis-promotion of medicines in the US, which is the company's largest research centre after Britain and home to almost a fifth of its 100,000 employees. Glaxo warned shareholders last November that it had put aside more than £2bn to pay for the settlement.
"We are determined to stop practices that jeopardise patients' health, harm taxpayers and violate public law," said James Cole, US deputy attorney general.
Glaxo admitted promoting Paxil, an anti-depressant, to patients under 18 even though it did not have permission from the Food and Drug Administration (FDA) to do so.
In 2000 and 2001, Glaxo's sales staff regularly held forums to discuss Paxil in destinations including Hawaii and Puerto Rico, where the psychiatrists attending were treated to golf, deep-sea fishing and balloon rides, according to the Department of Justice.
Related Articles
GlaxoSmithKline to buy Cellzome for £61m
15 May 2012
Glaxo makes hostile bid for Human Genome
09 May 2012
Shareholder: GlaxoSmithKline offer is bitter pill
29 Apr 2012
GlaxoSmithKline sells OTC drugs for £164m
20 Apr 2012
Unlike drug companies, doctors are allowed to prescribe medicines for uses that do not have approval by the FDA. According to the US government's lawsuit, one psychiatrist said that "the style of conference would have been more suitable for a convention of sales reps; this is supposed to be a scientific meeting. To me, the music lights, videos and MCs are off-putting and a distraction (even demeaning)."
Glaxo said yesterday that it has changed the way its sales staff are paid by eliminating individual sales targets and aligning their compensation more closely to the quality of treatment a patient receives.
The settlement "brings to a resolution difficult, long-standing matters for GSK", Sir Andrew Witty, Glaxo's chief executive, said. "I want to express our regret and reiterate that we have learned from the mistakes we made."
Glaxo will pay a $1bn criminal fine, with the rest settling civil liabilities. A portion will also go to whistleblowers who originally warned of the mis-promotion
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