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• updated 09/02/2010 9:54AM Allergan agrees to pay $600 million fine Irvine-based Allergan has agreed to pay $600 million to settle a government probe of the drug maker's past sales and marketing of unapproved uses for Botox.
  
  The firm said it reached a global settlement with the Department of Justice regarding the investigation. The company will plead guilty to a misbranding charge from 2000 through 2005 and pay $375 million.
  
  As part of the plea, Allergan has agreed that its marketing of the drug during that time period resulted in "intended uses" for the treatment of headache, pain, spasticity and juvenile cerebral palsy, even though the Food and Drug Administration had not approved them, and the product's labeling did not include directions for those uses.
  
  In addition, Allergan will pay $225 million to resolve civil claims under the False Claims Act. The company denies liability with the civil allegations, stating that it "does not believe there is merit to them factually or legally."
  
  To resolve the criminal and civil investigations, Allergan was also required to dismiss its lawsuit against the government in which the company sought to share scientific and medical facts with doctors about the effects of Botox in treatments that had not been approved by the FDA.
  
  "This settlement is in the best interest of our stockholders as it resolves all matters at issue in the investigation, avoids substantial costs of litigation, as well as the substantial risks to Allergan associated with government enforcement action in these matters, and permits us to focus our time and resources on productively developing new treatments for patients and the medical community,” said Douglas Ingram, Allergan’s executive vice president.
  
  The FDA this year OK'd Botox for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity, and the product's labels now include directions for that use, according to the company. Allergan also has filed for approval of Botox for the treatment of chronic migraines and expects a decision by the end of the year.
  
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