Today, I am pleased to announce that the Justice Department and our law enforcement partners have reached an historic $3 billion resolution with the pharmaceutical manufacturer GlaxoSmithKline, LLC, to resolve multiple investigations into the company’s sales, marketing, and pricing practices. This action constitutes the largest health care fraud settlement in United States history. ~ Deputy Attorney General James M. Cole
The case involves two antidepressants sold in the U.S. by the British pharmaceutical company GlaxoSmithKline(GSK), Paxil and Wellbturin, as well as false claims about the diabetes drug Avandia.
Deputy Attorney General James M. Cole explained that under the agreement just announced,
GSK will plead guilty to criminal charges and pay $1 billion in criminal fines and forfeitures for illegally marketing and promoting the drugs Paxil and Wellbutrin for uses not approved by the FDA – including the treatment of children for depression, and the treatment of other patients for ailments ranging from obesity, to anxiety, to addiction and ADHD – and for failing to report important clinical data about the drug Avandia to the Food and Drug Administration. GSK will pay an additional $2 billion to resolve civil allegations that it caused false claims to be submitted to federal health care programs for these and other drugs as a result of the company’s illegal promotional practices and payments to physicians. This settlement also resolves a civil investigation of the company’s alleged underpayment of rebates that were required under the Medicaid Drug Rebate Program. [emphasis mine]
The criminal complaint, filed in Massachusetts, claims GSK promoted Paxil as safe in treating depression for teens and children, despite the 2003 FDA warning against its use in this population. (You might want to see the post “‘The Reports of My Death Are Greatly Exaggerated’: As Is the Correlation of Antidepressants With Suicide” on how accurate those warnings turned out to be.)
They’re also in deep weeds for heavily promoting the use of Paxil through a force of 1900 sales reps who made personal calls to doctors, encouraging them to prescribe the med.
Additionally, although it only had FDA approval to treat depression, the company advertised that Wellbutrin could treat ADHD, obesity, additions, and sex and sexual dysfunction.
In a truly elegant touch, the Wellbutrin sales reps referred to the drug as ‘the happy, horny, skinny pill’ to remind doctors of its possible (unapproved) uses.
The settlement is breaking news, and you’ll see more coming out about it the entire day. Some trustworthy sources–beside the complaint–are below, and in “Related Articles”: Glaxo To Plead Guilty To 3 Charges In Sweeping Health Settlement (http://www.npr.org/blogs/health/2012/07/02/156116607/glaxo-pleads-guilty-to-3-charges-in-sweeping-health-settlement)
- Glaxo to Plead Guilty, Pay $3 Billion to U.S. to Resolve Fraud Allegations (http://online.wsj.com/article/SB10001424052702304299704577502642401041730.html)
- Deputy Attorney General James M. Cole Speaks at the GSK Press Conference (http://www.justice.gov/iso/opa/dag/speeches/2012/dag-speech-1207021.html)
- GlaxoSmithKline ‘guilty of fraud’ (bbc.co.uk)
- reuters: DEVELOPING: GlaxoSmithKline Plc has agreed to plead… (shortformblog.com)
- GlaxoSmithKline Reaches Plea Agreement Over Drug Labeling – Bloomberg (bloomberg.com)