Canadian Pharmaceutical Company and their Drop-Shipper Pleaded Guilty in Non-FDA Approved Medications Smuggling Charges

A Canadian pharmaceutical company and their drop-shipper were fined $45 million, as well as forfeiting $30 million for smuggling Non-FDA approved medications into the U.S. 5 men from Canada and the United States have also pleaded guilty to a multi-year conspiracy to ship misbranded and non-FDA approved pharmaceuticals to U.S. Clinics and Doctors’ Offices.

A Canadian pharmaceutical company and their drop-shipper were fined $45 million, as well as forfeiting $30 million for smuggling Non-FDA approved medications into the U.S. 5 men from Canada and the United States have also pleaded guilty to a multi-year conspiracy to ship misbranded and non-FDA approved pharmaceuticals to U.S. Clinics and Doctors’ Offices.

SB Medical Inc., and TC Medical Group of Toronto, Canada and St. Michael, Barbados pleaded guilty on May 7th 2015 to conspiracy to smuggle and sell misbranded prescription drugs in the United States and unlicensed wholesaling of prescription drugs, reports a Food and Drug Administration (FDA) press release.

According to the FDA SB Medical illegally imported “orthopedic injections, rheumatology infusions, cosmetic devices, opthomology products, and oncology drugs into the United States. The non-FDA approved prescription pharmaceuticals were sourced from other foreign countries including, India, Turkey, France, Italy, and other countries and included Lucentis, Mabthera, Botox, Dysport, Euflexxa, Remicade, Restylane, Synvisc, Prolia, Orencia, Orthovisc, and other products,” from 2011-2014.

As part of the conspiracy, drop shippers in the United States received foreign shipments of medication, and relabeled them for resale, so that they would appear to have been shipped from the U.S., the FDA reports.

In the press release, George M. Karavetsos, Director of the FDA Office of Criminal Investigations, stated that “Individuals who circumvent the FDA-regulated supply chain by distributing unapproved prescription drugs and medical devices put the health and safety of the American public at risk. The FDA has zero tolerance for those who participate in these illegal trafficking networks and, as we did in this case, we will continue to protect consumers by bringing such criminals to justice.”

In addition to the massive fines, the FDA reports that 5 individuals have also pleaded guilty as part of the smuggling conspiracy:

  • David Eli Burke, 34, of Thornhill, Ontario, Canada, director of sales
  • Shlomo David Rabi, 25, of Toronto, Ontario, Canada, director of sales and marketing
  • Asaf Akiva Ibrahimian, 24, of West Orange, New Jersey, sales representative
  • Reuven David Mirlis, 23, of Passaic, New Jersey, sales representative
  • Rivka Rabi, 26, of Lakewood, New Jersey, drop shipper

This case was investigated by the FDA’s Office of Criminal Investigations, Homeland Security Investigations Washington, D.C., with the assistance of the United States Postal Inspection Service. Assistant U.S. Attorneys Alexander T.H. Nguyen, Kellen S. Dwyer, and Jay V. Prabhu are prosecuting the case.

By S. Imber