GlaxoSmithKline to pay $3 billion for health fraud
By JESSE J. HOLLAND July 2, 2012 11:34AM
MIAMI, FL - FILE: A bottle of anti-depressant pills named Paxil are shown March 23, 2004 photographed in Miami, Florida. It was reported on July 2, 2012 that pharmaceutical company GlaxoSmithKline will plead guilty with Justice Department and pay $3 billion in the largest settlement of health care fraud in U.S. history. The company is to plead guilty to a three-count criminal information, including two counts of introducing misbranded antidepressant drugs Paxil and Wellbutrin to interstate commerce and one count of failing to report safety data about the diabetes drug Avandia to the FDA. (Photo Illustration by Joe Raedle/Getty Images)
Updated: August 4, 2012 6:18AM
WASHINGTON — GlaxoSmithKline LLC will pay $3 billion and plead guilty to promoting two popular drugs for unapproved uses and to failing to disclose important safety information on a third in the largest health care fraud settlement in U.S. history, the Justice Department said Monday.
The $3 billion fine also will be the largest penalty ever paid by a drug company, Deputy Attorney General James M. Cole said. The corporation also agreed to be monitored by government officials for five years to attempt to ensure the company’s compliance, Cole said.
“Let me be clear, we will not tolerate health care fraud,” Cole told a news conference at the Justice Department. He would not say whether any company executives were under investigation. The company’s guilty plea and sentence have to be approved by a federal court in Massachusetts.
“For far too long, we have heard that the pharmaceutical industry views these settlements merely as the cost of doing business,” Acting Assistant Attorney General Stuart F. Delery, head of Justice’s civil division, said at the news conference. “That is why this administration is committed to using every available tool to defeat health care fraud.”
It is illegal to promote uses for a drug that have not been approved by the Food and Drug Administration — a practice known as off-label marketing.
Prosecutors said GlaxoSmithKline illegally promoted the drug 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 the drug 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 only approved 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.