Drugs, drugs more drugs GSK $3Billion settlementlion

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July 2, 2012Glaxo Pleads Guilty, Will Pay $3 Billion to Settle Health Care Fraud ChargesGlaxoKline (GSK) has agreed to plead guilty to criminal charges and pay $3 billion to resolve civil and criminal allegations in the largest health care fraud settlement in U.S. history. In its announcement today, the U.S. Justice Department stated that the settlement includes $2 billion to resolve civil liabilities and $1 billion in criminal fines. The deal states that GSK is required to plead guilty to criminal charges involving three of the company's drugs: Paxil and Wellbutrin, both antidepressants, and Avandia, a diabetes drug. The government’s case involved allegations GSK illegally marketed Paxil for off label use in children and adolescents despite the drug never being approved by the FDA for that population. The government also alleged GSK published an article ghostwritten by a medical communications company hired by GSK that falsely promoted Paxil as safe and effective for children. These allegations were previously brought to light in consumer fraud cases in 2004, one brought by Baum Hedlund and another by the New York Attorney General on behalf of the State of New York. In the government case, GSK was also accused of illegally marketing Wellbutrin for a wide variety of unapproved uses, including weight loss, sexual dysfunction, attention deficit hyperactivity disorder and substance addiction. In addition, the government claimed that, between 2001 to 2007, Glaxo failed to report data from studies that looked at the cardiovascular safety of the diabetes drug, Avandia. Avandia use was restricted in 2010 after being linked to heart risks. The Justice Department also accused GSK of paying kickbacks to doctors in order to encourage off label uses of its drugs. These kickbacks came in the form of lavish vacations, concert tickets, spa trips, lunches and dinners. MSNBC reports the drugmaker will enter into a five-year corporate integrity agreement with the government.The case is U.S. v. GlaxoKline LLC, U.S. District Court for the District of Massachusetts, No. 12-cr-10206