On January 29, 2014, the U.S. Department of Justice (DOJ) announced that seven Ohio oncologists had been sentenced to probation for purchasing cancer medications for patients from a foreign supplier. Each doctor pleaded guilty to causing the shipment of misbranded drugs, a misdemeanor, reports the DOJ.
In each case, the doctors admitted to making cancer drug purchases from a distributor identified in court documents as “Company #1.” Some of the doctors had foreign drug shipments seized by the FDA. Documents in the cases note that some shipments had a return shipping address in Manitoba, while others had return shipping labels for the Netherlands Antilles. The doctors reported in each case that they had been solicited by sales people from the distributor, who assured them that importing the cancer drugs was legal.
Ranjan Bhandari paid the single greatest fine, $1,139,532. He admitted at his sentencing that he became suspicious of “Company #1” after a shipment of Aranesp (indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis) that he had ordered, was not shipped in the required refrigerated state, so he refused delivery and discontinued purchasing from “Company #1.”
David Fishman and Hassan Tahsildar paid $150,000 and $179,316 in fines respectively. Dr. Fishman’s sentencing documents reveal that in 2008 alone his practice was sent at least 4 different notices by the FDA warning that foreign drugs they had ordered were being held by customs.
Timmappa Bidari, who paid a fine of $158,418, received a warning from the FDA indicating the drugs he had imported via Canada were actually shipped from the Netherlands Antilles, according to his sentencing documents.
Marwan Massouh, who paid a fine of $609,150, claimed in his sentencing documents that he did not know that his purchases were illegal and that the supplier’s literature implied that it was legal to import the drugs from Canada.
Poornanand Palaparty paid a fine of $128,160. Dr. Palaparty’s sentencing documents state that FDA investigators who visited his offices took photographs of the drugs on Dr. Palaparty’s shelves. Several of the drugs featured packaging in Turkish or other languages.
Su-Chiao Kuo paid a fine of $179,840. In her sentencing documents, Dr. Kuo stated to investigators that representatives from “Company #1” encouraged her to call the office manager at a large medical practice in Michigan to get a reference for their services. The office manager referred to “Company #1” as “trustable” [sic].
Doctors are often solicited via fax blast from unlicensed medicine distributors. They can easily verify the license of the distributor by looking to see if the wholesaler is a Verified-Accredited Wholesale Distributor (VAWD) by the National Association of Boards of Pharmacy. They can also check the state licensing authority to verify that a wholesale drug distributor is licensed in the states where it is conducting business. The FDA has a list of links to the state licensing agencies across the U.S.
Doctors can download the Rx-360 Protect Your Patient-Know Your Supplier materials to share with purchasing staff.