The FDA and Department of Justice have taken down another company that brought foreign-made drugs into the country and sold them to physician practices. They say that an Illinois man and his company grossed $3 million in three years, selling Allergan's ($AGN) Botox and Juvederm 2 and 3 that were made for the U.K., and 6 countries in the Middle East.
The agency says Alton, IL-based Orthopaedic Solutions, pleaded guilty to a felony charge of introducing a misbranded drug into interstate commerce. Owner Christopher Carstens, 49, pleaded guilty to a misdemeanor. He will pay a $50,000 fine, while the company will forfeit nearly $375,000, the FDA said in a release. He will be sentenced later.
For 18 months in 2009 and 2010, undercover agents bought the foreign-made and mislabeled drugs from Carstens. He brought in 5,879 units that were made for the U.K., United Arab Emirates, Bahrain, Kuwait, Lebanon, Oman and Palestine. The foreign Botox was considered misbranded because the labeling didn't include directions for use, adequate "black box" warnings and lacked the symbol "Rx only."
This was not the only time that foreign-made versions of the cosmetic drug have been offered to doctors. In late 2012, the FDA warned 350 physician practices that foreign-made versions had come into the U.S. through a Canadian online pharmacy. Several months later, they said that the drug being offered through blast faxes was foreign-made but the labeling had been faked to make it appear it was made for the U.S. market.
- here's the release