The United States Attorney’s Office announced that Massachusetts-based medical corporation, Greater Boston Behavioral Health LLC, has agreed to plead guilty to charges related to the receipt of misbranded drugs and to pay in excess of $2.5 million in fines and forfeiture. Pursuant to a criminal information filed in federal court in Boston, the United States charged Greater Boston Behavioral Health with violations of the Food, Drug and Cosmetic Act. As part of the criminal resolution, Greater Boston Behavioral Health has agreed to plead guilty to a misdemeanor offense, to pay a criminal fine of $657,678 and to forfeit $1,929,464.
According to the criminal information, Greater Boston Behavioral Health sought out sources from which it could purchase Botox® that was packaged and labeled only for sale in the United Kingdom and other foreign countries. The label of the foreign Botox purchased by Greater Boston Behavioral Health differed from the FDA-approved label for Botox and Botox Cosmetic and lacked the designation “Rx Only” as required by the FDCA for prescription drugs. The label also typically did not include the FDA-required “black-box warning” concerning potential side-effects of Botox. Greater Boston Behavioral Health purchased foreign Botox at prices significantly below the price that Allergan and its authorized distributors charged for Botox and Botox Cosmetic that was manufactured and labeled for sale in the United States. Doctors at Greater Boston Behavioral Health used the foreign Botox to treat patients suffering from migraine headaches and did not disclose to these patients that they purchased the drug from foreign sources or that it was not labeled for distribution in the United States.
