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AHL’s TOP STORY: GSK Agrees To Pay U.S. Government $3B in Largest Drug Fraud Settlement

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The U.S. Department of Justice on Monday announced a $3 billion settlement agreement with GlaxoSmithKline — said to be the largest health care fraud settlement in U.S. history — to resolve allegations that the British drugmaker broke U.S. laws in marketing several products, Reuters reports (Ingram, Reuters, 7/2)

Under the agreement, GSK will pay the settlement and plead guilty to misdemeanor criminal charges for illegally marketing antidepressants Paxil and Wellbutrin and for failing to report the safety data on diabetes drug Avandia, the New York Times reports (Thomas/Schmidt, New York Times, 7/2).

Specifically, a DOJ investigation found that, from the late 1990s to 2007, GSK:

  • Marketed Paxil, which was approved only for adults, to patients under age 18;
  • Marketed Wellbutrin for unapproved uses, including weight loss and sexual dysfunction treatment;
  • Went to extreme lengths to promote Paxil and Wellbutrin, including distribution of a misleading medical journal article and illegal kickbacks to physicians (D’Urso, Los Angeles Times, 7/2);
  • Failed to provide Avandia safety data to FDA; and
  • Failed to report “best prices” to Medicaid for certain drugs (Reuters, 7/2).

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Written by AHLAlerts

July 3, 2012 at 2:06 pm

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