GlaxoSmithKline agrees to $3 billion settlement with Justice Department
in largest sum of its kind over health care fraud


(CBS News) Pharmaceutical giant GlaxoSmithKline will plead guilty and
pay $3 billion in the largest settlement of health care fraud in U.S.
history, the Justice Department announced Monday.

The settlement will resolve criminal and civil liability from the
company's unlawful promotion of certain prescription drugs. 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. The criminal
complaints will total $1 billion.

GSK will also pay $2 billion to resolve civil liabilities relating to
Paxil, Wellbutrin and Avandia, as well as other drugs and also resolves
allegations of pricing fraud.

The Justice Department said GlaxoSmithKline unlawfully promoted Paxil
for treating depression in patients under 18 without FDA approval for
pediatric use. The U.S. also alleged the company published and
distributed a misleading medical journal article misrepresenting the
drug's efficacy in treating depression in adolescents, also sponsoring
dinners, spa programs and other activities to promote that use.

The Justice Department also contends that in 2003, GSK paid millions to
doctors to promote Wellbutrin, approved at the time for depression, for
off-label uses by funding meetings, sometimes at lavish resorts.

For Avandia, the U.S. alleged GSK failed to report certain safety data
between 2001 and 2007 that have since led to "black box" warning labels
of about the drug's potential to increase risk for heart failure and
heart attack.