government
Drug company agrees to $3 billion health fraud settlement
NEWS IN BRIEF — Posted July 16, 2012
Pharmaceutical giant GlaxoSmithKline LLC will pay the federal government $3 billion to resolve health care fraud allegations, including accusations that the company paid physicians to endorse and prescribe its drugs. The settlement is the largest of its kind in U.S. history, the Justice Dept. said.
GlaxoSmithKline also has agreed to plead guilty to unlawful promotion of prescription drugs and failure to report safety data to the Food and Drug Administration.
The resolution marks the culmination of an extensive investigation by the Dept. of Health & Human Services Office of Inspector General and the Federal Bureau of Investigation. Law enforcement agents started investigating GlaxoSmithKline’s drug practices in 2004.
Among other discoveries, investigators found that from April 1998 to August 2003, the company promoted Paxil (paroxetine) for treating depression in patients younger than 18, even though the FDA never had approved the drug for pediatric use. The drug company also participated in preparing, publishing and distributing a misleading medical journal article that reported Paxil had demonstrated efficacy in the treatment of depression in patients younger than 18, the Justice Dept. said.
In addition, GlaxoSmithKline promoted Lamictal (lamotrigine), an anti-epileptic medication, for off-label psychiatric uses, neuropathic pain and pain management. Investigators also found the company promoted Wellbutrin (bupropion) for weight loss, the treatment of sexual dysfunction and substance addictions. At the time, the drug was approved only for treating major depressive disorder.
The Justice Dept. said the drug company paid millions to physicians to speak during meetings, often held at lavish resorts, at which off-label uses of Wellbutrin were routinely promoted. The company used sales representatives, sham advisory boards and false independent continuing medical education programs to promote Wellbutrin for unapproved uses, the government said.In a statement, GlaxoSmithKline CEO Sir Andrew Witty expressed regret at the company’s former practices and said it had “learned from the mistakes that were made.” The company is deeply committed to transparency and displaying integrity in its business practices, Witty said.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2012/07/16/gvbf0716.htm.