Today, the U.S. District Court of the Eastern District of Missouri sentenced Sabahhadin Akman, 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.
In August 2014, Akman pleaded guilty to the same charges. Akman's sentencing follows that of his business partner, Ozkan Semizoglu, who in October 2014 was sentenced to 27 months in federal prison on similar charges.
"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 FDA will continue to bring to justice those who violate federal laws and bring harm to patients."
Akman admitted in his plea agreement to selling Altuzan to Richard Taylor, a drug wholesaler in the United Kingdom. In 2012, the FDA's OCI agents seized Altuzan from various U.S. physicians and customers of Taylor. OCI ultimately determined that some of the Altuzan being sold by Taylor and Akman was counterfeit, with no active drug ingredient in the drug vials. The FDA issued several public safety alerts about these events.
The FDA acknowledges the collaboration and investigative assistance of its law enforcement partners in this case, including the U.S. Marshals Service; the U.S. Attorney's Office for the District of Puerto Rico; the U.S. Department of Health and Human Service's Office of the Inspector General; the Johnson County, Kansas, Sheriff's Office Criminalistics Laboratory; Europol; the Bonn prosecutor in Germany (Staatsanwaltschaft); the Federal Criminal Police of Germany (Bundeskriminalamt, BKA); the Dusseldorf Police, the German State Criminal Police (Landeskriminalamt, LKA); the U.S. Department of State's Diplomatic Security Service; the U.S. Consulate General's Overseas Criminal Investigations Branch in Istanbul, Turkey; and the Drug Enforcement Administration.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.