GlaxoSmithKline Agrees to $3 Billion Settlement With Justice Department in Largest Sum of Its Kind Over Health Care Fraud
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.