Seven oncologists in six different Ohio cities have been charged with illegally importing misbranded, non-FDA approved cancer medication.
The U.S. Department of Justice (DOJ) is reporting that seven Ohio cancer doctors are facing allegations of importing non-FDA approved cancer medications. The seven were each charged with a misdemeanor, “causing the shipment of misbranded drugs.” The DOJ press release identifies the doctors as Dr. Ranjan Bhandari of Liverpool, Dr. Timmappa Bidari of Parma, Dr. David Fishman of Euclid, Dr. Su-Chiao Kuo of Brunswick, Dr. Marwan Massouh of Westlake, Dr. Poornanand Palaparty of Cleveland, and Dr. Hassan Tahsildar of Euclid, Ohio.
The accused are alleged to have purchased drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, reports the DOJ. The press release does not identify where the drugs came from, but makes clear they were non-FDA approved medications ordered illegally. According to the Canton Rep, U.S. Attorney Steven Dettelbach stated that the drugs were purported to have come from Canada.
The DOJ press release points out that, “A drug may be considered misbranded even if it is identical in composition to an FDA-approved drug (that is, a drug labeled and packaged in compliance with the FDA’s standards) and even if it was made by the same manufacturer in the same facility as the FDA-approved version.”
Health Canada, the Canadian health regulatory agency, warns that that purchasing drugs “from Canada” does not actually guarantee that the drugs were manufactured in, or approved for sale in Canada. Many medications sold through illicit sources claim to be Canadian, but are instead made in other foreign locales without the safeguard of FDA oversight.
In the Food and Drug Administration’s (FDA’s) press release on the occasion of the charges being filed, Antoinette V. Henry, Special Agent in Charge of FDA’s Office of Criminal Investigations explained the agency’s motivation in pursuing these doctors, “FDA’s regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers. We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products.”
By S. Imber