Written By Blair Koster
In the largest health care fraud settlement in U.S. history, GlaxoSmithKline (GSK) will pay $3 billion and plead guilty to fraudulently promoting drugs for unapproved Food and Drug Administration (FDA) use. According to the Richmond Times-Dispatch, the criminal charges are related to branding, safety information and price reporting of drugs including Paxil, a popular antidepressant, Lamictal, an anti-seizure medication, Advair, a drug for mild asthma, and Zofran, a drug approved only for post-operative nausea.
At a GSK press conference in Washington, D.C. on July 2, 2012, Attorney General James M. Cole said that 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 non-approved FDA uses.
The drug Paxil, for example, was marketed for depression in children, although the FDA had never approved its use for children under the age of 18. In fact, according to the suit United States of America v. GlaxoSmithKline, three clinical studies failed to establish Paxil’s effectiveness for treating depression in children and adolescents. Not only this, but GSK is alleged to have helped to write and approve a medical journal article which falsely stated a study had demonstrated Paxil was effective in treating depression in adolescents.
The suit also alleges that Wellbutrin, only approved by the FDA for “major depressive disorder in adults 18 and older,” was promoted for weight loss, treatment of sexual dysfunction, substance addictions, Attention Deficit Hyperactivity Disorders and other unapproved uses.
In addition to other illegal promotions, “GSK paid doctors to attend lavish meetings in places such as Jamaica and Bermuda during which GSK provided off-label information. GSK tried to disguise the promotional nature of these meetings by characterizing them as ‘speaker training’ meetings.” According to the suit, GSK also held continuing medical education programs for doctors, though in some meetings, GSK influenced the content.
GSK is also criminally charged for failing to report to the FDA clinical data about the drug Avandia, a diabetes medication. In addition to the $1 billion, GSK will pay $2 billion to resolve allegations that “it caused false claims to be submitted to federal health care programs for these and other drugs.” The settlement also alleges that the company not only participated in illegal promotional practices, but illegally paid physicians to market the drugs. These are not all of the allegations
At the conference, Cole said that the Justice Department and law enforcement partners, including the FBI, had participated in multiple investigations into this, the “largest health care fraud settlement in United States history.” He said that this multi-billion dollar settlement is unprecedented in both size and scope. “At every level, we are determined to stop practices that jeopardize patients’ health, harm taxpayers and violate the public trust– and this is a clear warning to any company that chooses to break the law.”
For further information, go to The United States Department of Justice website, http://www.justice.gov/opa/gsk-docs.html. Most of the information in this article is based on the GSK Court Documents. Go to Court Documents and click “GSK Criminal Information” to read the entire testimony.