Ozkan Semizoglu earlier had pleaded guilty to charges that he and his company, Ozay Pharmaceuticals, shipped counterfeit versions of life-saving cancer medications into the United States. Ozay Pharmaceuticals was one of several sources for the fake cancer drugs that have plagued U.S. oncology clinics since 2012.
The Department of Justice (DOJ) has announced that Ozkan Semizoglu, the director of Turkish drug importer, Ozay Pharmaceuticals, was sentenced to 27 months in prison for his role in distributing counterfeit cancer medication in the United States.
According to the DOJ, Semizoglu shipped “counterfeit, misbranded, and adulterated cancer treatment drugs into the United States, including multiple shipments of Altuzan® (the Turkish version of Avastin®) that he sent from Turkey to Chesterfield, Missouri.”
Semizoglu’s indictment listed the startling variety of cancer treatments his company imported into the United States: Altuzan, (called Avastin in the U.S.) which is used to treat cancerous tumors, Gemzar which is used to treat breast cancer, some types of lung cancer, and pancreatic cancer, Taxotere which is used to treat breast cancer, lung cancer, prostate cancer, stomach cancer, and head and neck cancer, Eloxatin which is used to treat colon cancer, Zometa which is used to treat bone cancer, bone disease, and osteoporosis, and Venofer/Iron sucrose, which is used in the treatment of anemia, and chronic kidney disease.
The indictment also listed three different temperature-sensitive medications, none of which were shipped with appropriate temperature controls: Neupogen, a drug used to encourage white blood cell growth after chemotherapy, Herceptin, a breast cancer treatment, and Rituxan, used in the treatment of cancer and rheumatoid arthritis.
According to the indictment, “Defendants shipped prescription drugs requiring constant cold temperatures in shipping boxes without insulation from Turkey to the United States. Defendants further shipped prescription drugs requiring constant cold temperatures in shipping boxes from Turkey to the United States without any temperature protection whatsoever, or sometimes used only small freezer packs instead of dry ice inside the packages. Given the length of time to ship products from Turkey to the United States, defendants were aware that on many occasions their packages of their prescription drugs arrived in the United States at temperatures outside the constant cold temperature range discussed on the drugs’ labeling.”
The indictment also reports that Ozay Pharmaceuticals repeatedly used disingenuous customs labels such as “gifts” or “documents” or “product sample” to fool customs agents as to the packages true contents.
The DOJ also reports that in his plea agreement, Semizoglu admitted that he sold the Turkish version of Avastin, called Altzuan, to Richard’s Pharma, a U.K. drug wholesaler that was responsible for one of the counterfeit cancer drug incidents in 2012. Testing of the Ozay Pharmaceuticals drugs that Richard Taylor sold in the United States found that they contained no active ingredient at all.
According to Philip J. Walsky, acting director of the Food and Drug Administration’s Office of Criminal Investigations, “Today’s sentencing marks a public recognition that we will continue to pursue and bring to justice those who violate the law and jeopardize public safety. National borders can no longer keep out criminal activity. As we did in this case, we will work with our international partners to protect U.S. public health.”
This case was investigated by FDA’s Office of Criminal Investigations. FDA-OCI received assistance from both U.S. and abroad, receiving help from the United States Marshal’s Service, the United States Attorney’s Office 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 Sherriff’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 case was prosecuted by the Health Care Fraud Unit of the U.S. Attorney’s Office for the Eastern District of Missouri.