The U.S. District Court of the Eastern District of Missouri on January 23, 2015 sentenced an owner of the Turkish firm Ozay Pharmaceuticals to 30 months imprisonment and a $150,000 fine for smuggling counterfeit, misbranded, and adulterated cancer treatment drugs into the U.S., including multiple shipments of Altuzan, the Turkish version of Avastin. Another business partner in the drug wholesaling scheme was sentenced in October 2014.
"The serious public health impact of counterfeit cancer medications in the supply chain compelled the FDA to mobilize resources throughout the country to track down the U.S. wholesalers and medical practices that had purchased this illegal product,” said Philip J. Walsky, acting director of the FDA’s Office of Criminal Investigations (OCI). “We worked closely with state regulatory agencies to publicly warn people that these products had reached the U.S.”
The owner admitted in his plea agreement to selling Altuzan to a drug wholesaler in the United Kingdom. In 2012, the FDA’s OCI agents seized Altuzan from various U.S. physicians and customers of the British wholesaler. OCI ultimately determined that some of the Altuzan being sold was counterfeit, with no active drug ingredient in the drug vials. The FDA issued several public safety alerts about these events.
See the FDA Announcement
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication
See also Medical Law Perspectives, November 2014 Report: More Than Skin Deep: Skin Cancer Misdiagnosis and Other Liability Issues
See also Medical Law Perspectives, October 2012 Report: Mistakes in Diagnosing Cancer: Liability Concerns for Misdiagnosis, Failure to Diagnose, and Delayed Diagnosis