Washington - GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs - Paxil and Wellbutrin - for unapproved uses and to failing to disclose important safety information on a third drug - Avandia - in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.
Accompanying the criminal case was a civil settlement in which the government said the company's improper marketing included providing doctors with expensive resort vacations, European hunting trips, high-paid speaking tours and even tickets to a Madonna concert.
Some of the settlement money will come to Wisconsin.
Prosecutors said GlaxoSmithKline illegally promoted Paxil for treating depression in children from April 1998 to August 2003, even though the FDA never approved it for anyone under age 18. The corporation also promoted Wellbutrin from January 1999 to December 2003 for weight loss, the treatment of sexual dysfunction, substance addictions and attention deficit hyperactivity disorder, although it was approved only for treatment of major depressive disorder.
Justice Department officials also said that between 2001 and 2007 GlaxoSmithKline failed to report to the FDA on safety data from certain post-marketing studies and from two studies of the cardiovascular safety of the diabetes drug Avandia. Since 2007, the FDA has added warnings to the Avandia label to alert doctors about potential increased risk of congestive heart failure and heart attack.
SALES OF THE DRUGS
The $3 billion that GlaxoSmithKline LLC will pay in the largest health care fraud settlement in U.S. history represents only a portion of what the company made on the three drugs involved. Avandia racked up$10.4 billion in sales, Paxil brought in $11.6 billion, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a data group that consults for drug makers.
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