Off-Label Marketing Case Settled by Pfizer for $55M

For off-label marketing of the drug Protonix and other fraudulent conduct, Pfizer has agreed to pay $55 million in its settlement with the United States Department of Justice. Protonix is an acid reflex drug produced by Wyeth, which is owned by Pfizer. Off-label marketing “Wyeth tried to cheat the system by obtaining a limited FDA approval for Protonix, fully intending to promote this drug for additional, unapproved uses,” stated U.S. Attorney Carmen Ortiz. The Food and Drug Administration only approved Protonix for a particular kind of gastro-esophageal reflux disease (GERD)...

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Abbott Labs Fined $700M for Off Label Marketing

For off label marketing of the drug Depakote, a federal district judge last week ordered Abbott Laboratories to pay a $500 Million criminal fine, to forfeit $198.5 Million, and to pay $1.5 Million to the Virginia Medicaid Fraud Control Unit. In May, Abbott Laboratories pled guilty to off-label marketing of Depakote for dementia and schizophrenia, uses not approved by the FDA.  It also settled allegations that it marketed Depakote for psychiatric illnesses in children, including conduct disorders, attention deficit disorder and autism, and other psychiatric illnesses in adults, including...

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Off-label Drug Marketing of Antipsychotic Drugs for Children?

A new study found a 62% increase in the number of children ages 3 to 18 who are enrolled in Medicaid taking antipsychotic drugs in the last ten years.  The number of children taking such antipsychotics was 354,000 in 2007.  Science Daily reports: Increased antipsychotic use was observed across a wide range of mental health diagnoses, and was particularly high for children with ADHD or conduct disorder, although the FDA has not approved the drugs to treat these conditions in children. In total, 65% of children prescribed antipsychotics in 2007 were using the drugs “off-label,” or...

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GlaxoSmithKline to Pay $3 Billion in Pharmaceutical Whistleblower Case

Pharmaceutical company GlaxoSmithKline has agreed to pay $3 billion in fines to the government in a pharmaceutical whistleblower case.  This is the largest pharmaceutical fraud settlement to date, and brings whistleblower lawsuit settlements to a total of $10 billion for 2012.  Whistleblowers get a share of these settlements as a reward for reporting fraud under the False Claims Act. The pharmaceutical whistleblowers were four GSK employees, including a vice president and a senior marketing development manager.  The pharmaceutical fraud involved GSK’s conduct regarding Paxil,...

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