A director of Ozay Pharmaceuticals, the Turkish drug distributor responsible for one of the infiltrations of counterfeit cancer medication into the secure U.S. drug supply chain, has pleaded guilty to charges related to the importation of counterfeit Avastin and other counterfeit cancer medications into the United States.
Turkish national Ozkan Semizoglu pleaded guilty to charges of smuggling counterfeit, adulterated and non-FDA approved cancer medication into the United States on July 22, 2014, reports the Department of Justice (DOJ). According to the DOJ, Semizoglu used falsified shipping and customs labels that described the prescription drug shipments as “gifts,” “documents,” or “product sample” with little or no monetary value.
The DOJ also reports that Semizoglu made no arrangements to temperature-control storage for the drugs he shipped, in spite of the fact that the cancer drugs he claimed to offering for sale all have strict storage temperature requirements.
According to the DOJ, the companies and doctors’ offices that Semizoglu sold his misbranded cancer medications to included Richard’s Pharma, a Canada Drugs-owned wholesale drug distributor based in the United Kingdom that was managed in the UK by Richard Taylor. When Semizoglu was initially charged, the FDA reported that Ozay Pharmaceuticals had sold the counterfeit cancer medication that Richard’s Pharma had in turn sold to US doctors’ offices and clinics.
In 2013, the FDA reported that Richard Taylor pleaded guilty to charges that he sold misbranded and adulterated cancer medication to US doctors’ offices and clinics.
According to the FDA report on Richard Taylor’s plea agreement, Taylor acknowledged that he “was notified that [a patient] ‘had an unfortunate experience’ after an oncology nurse of a U.S. doctor reported that two patients had ‘immediate bad reactions’ during infusions of Altuzan. One of these patients ‘who has been on Avastin for a while started to shake in the middle of being transfused and had to be disconnected from treatment.’ The nurse advised that she had been administering Avastin for years and never had a patient reaction like this before.”
In the last 3 years, the FDA has sent more than 1000 warning letters to medical professionals who may have bought illegally imported medications from black market suppliers like Richard’s Pharma.
Today’s guilty plea marks a significant step in national and international cooperation,” said Philip J. Walsky, acting director, FDA Office of Criminal Investigations. “Federal, state and local officials in the U.S. and Germany and at Europol worked together in partnership to help protect the public’s health and remove a potentially unsafe medication from the U.S. marketplace.”
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This case was investigated by FDA’s Office of Criminal Investigations, with assistance from the United States Marshal’s Service; Rosa Emilia Rodríguez-Vélez , the United States Attorney for the District of Puerto Rico, the Office of Inspector General for the U.S. Department of Health and Human Services, the Johnson County, Kansas Sheriff’s Office Criminalistics Laboratory, 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. In addition, several enforcement entities outside the United States provided assistance: Europol, the Bonn prosecutor in Germany (Staatsanwaltschaft), the Federal Criminal Police of Germany (Bundeskriminalamt, BKA), the Dusseldorf Police, and the German State Criminal Police (Landeskriminalamt, LKA).
Hear more about cases like these at the Partnership for Safe Medicine’s Interchange on September 18, 2014 in Washington, DC. Tickets are available here.