Monday, February 7, 2005
The U.S. Attorney's Office for the Southern District of Florida (Miami) announced the indictment of three doctors and four corporations on mail/wire fraud, drug labeling, and conspiracy charges related to the sale of unapproved Botox to doctors for use in facial enhancement programs for their patients. According to the press release:
[T]he defendants purchased 3,081 vials, each containing five (5) nanograms of Botulinum Toxin Type A and other ingredients, in a formulation designed to imitate Allergan’s Botox®Cosmetic, the only product made with Botulinum Toxin Type A that is approved by the FDA for use in human beings. The defendants then engaged in a scheme to defraud by marketing and selling to health care providers for use in human patients the fake Botox as a cheap alternative to Allergan’s Botox® Cosmetic, without the administering health care providers advising their human patients that the fake Botox was not Allergan’s Botox® Cosmetic and was not approved by the FDA for use in human beings.