In the largest healthcare fraud settlement in U.S. history, pharmaceutical company GlaxoSmithKline will pay $3 billion in fines for promoting popular drugs for unapproved uses and failing to disclose important safety information on a dangerous drug.
According to court documents, from April 1998 to August 2003, GlaxoSmithKline illegally promoted the drug Paxil for treating depression in children, even though the Food and Drug Administration (FDA) never approved it for use in anyone under the age of 18.
Additionally, Justice Department officials said that from January 1999 to December 2003, the company also promoted the drug Wellbutrin for weight loss, sexual dysfunction, substance addiction, and attention deficit hyperactivity disorder, although it was only approved by the FDA for the treatment of major depressive disorder.
Prosecutors also revealed that between 2001 and 2007, GlaxoSmithKline failed to report data to the FDA regarding several studies on the cardiovascular safety of the diabetes drug Avandia. Since then, the FDA has added warnings to Avandia for an increased risk of heart attack and heart-related chest pain.
In addition to their criminal charges, GlaxoSmithKline agreed to resolve civil liabilities for promoting the drugs Advair, Lamictal, Paxil, Wellbutrin, and Zofran for unapproved treatments. They also had to resolve accusations that the company bribed doctors with luxury vacations and million-dollar speaking tours to prescribe the medications involved in the civil suit, as well as the drugs Imitrax, Lotronex, Flovent, and Valtrex.
Included in the penalties are $1 billion for criminal fines and $2 billion for civil settlements with the federal government, Massachusetts, and Colorado.