A Massachusetts healthcare company pleaded guilty and agreed to pay millions of dollars after officials said it intentionally purchased and used Botox labeled as being sold only in foreign countries. bottom.
Needham-based Greater Boston Behavioral Health has to pay more than $2.5 million in fines and forfeitures.
“Greater Boston Behavioral Health has ignored laws designed to keep patients safe,” says U.S. Attorney Rachael Rollins Said in a statement. “The Federal Attorney’s Office is committed to protecting patients and the integrity of the federal health care program, and to ensure that health care providers act in accordance with regulations that protect the public and ensure the quality of care, I will continue to use my criminal powers.”
The company sought out sources from which it could buy packaged and labeled Botox for sale only in the UK and other foreign countries, according to people familiar with the matter.
The Botox and Botox Cosmetic products purchased by Greater Boston Behavioral Health did not have the FDA-required “Rx Only” designation on their labels. According to Rollins’ office, in most cases the labels were missing the FDA-required “black box warnings” to inform customers about Botox’s side effects.
Greater Boston Behavioral Health buys this foreign botox at a price “significantly lower” than what authorized distributors charge for the same product manufactured in the United States and labeled for sale. I was able to.
Doctors working at Greater Boston Behavioral Health have used foreign-made Botox to treat patients suffering from migraines, officials said. They did not disclose to these patients that the Botox was purchased from a foreign source or was not labeled for distribution in the United States.
The company was indicted for violating the Food, Drug, and Cosmetic Act. Greater Boston Behavioral Health pleaded guilty to misdemeanor crimes and agreed to pay a criminal fine of $657,678 and forfeit $1,929,464.
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