Botox Bust: Pharmaceutical Giant Allergan Agrees To Pay $600 Million To Resolve Allegations That It Unlawfully Marketed Botox For Off-Label Uses

On September 1, 2010, the U.S. Department of Justice announced that it had reached an agreement with Allergan Inc. in which the pharmaceutical company has agreed to plead guilty to a criminal misdemeanor for misbranding Botox in violation of the Food, Drug and Cosmetic Act.  According to the Government, Allergan unlawfully promoted Botox for “off-label” uses that had not been approved by the Food and Drug Administration.  Under the settlement agreement, Allergan will pay a criminal fine and forfeiture totaling $375 million.  The company has also agreed to pay the Government and states $225 million to settle three qui tam lawsuits brought by whistleblowers under the False Claims Act.  As a reward for disclosing Allergan’s unlawful activity to the Government, the whistleblowers will receive a $37.8 million share of the settlement.

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