U.S. Department
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Press Release
Press Release
Greenville Medical Practice Receives Probationary Sentence and Agrees to Pay $300,000 to the United States
For Immediate Release
U.S. Attorney's Office, District of South Carolina
Contact Person: Bill Watkins
Columbia, South Carolina ---- Acting United States Attorney Beth Drake stated today that Neurology Associates of Greenville, P.A., pled guilty and was sentenced today in federal court in Greenville, for receiving misbranded drugs in interstate commerce, a violation of Title 21, United States Code, Section 331(c). United States Magistrate Judge Jacquelyn D. Austin of Greenville placed the practice on 3 years of federal probation. No fine was imposed because the practice, in settlement of a parallel civil case brought by the U.S. Attorney’s Office, agreed to pay $300,000 to the United States due to the submission of Medicare claims for non-approved botulinum toxin (Botox).
Evidence presented at the change of plea hearing established that under federal law no form of Botox may be commercially distributed for use on humans unless it has been approved by FDA. Only Allergan’s product manufactured in the United States is approved and licensed by the FDA. Records obtained during this investigation show that the practice from 2010-2013 purchased non-FDA approved Botox from a wholesaler who purchased the Botox from a factory in Ireland. This drug is deemed misbranded under federal law as it was not FDA approved for sale in the United States. The practice received this non-FDA approved Botox in interstate commerce.
The case was investigated by agents of the Office of Inspector General of the Department of Health and Human Services. Assistant United States Attorney Bill Watkins of the Greenville office handled the criminal case and Assistant United States Attorney Jennifer Aldrich of the Columbia office handled the civil case.
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Updated August 29, 2016
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