June 6, 2014: Supplier of Non-FDA Approved Chemotherapy and Cosmetic Drugs Sentenced to 15 Months
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
June 6, 2014
United States Attorney
Eastern District of Virginia
Contact: Press Officer
ALEXANDRIA, Va. – Mirwaiss Aminzada, 44, of Montreal, Quebec, and Dubai, United Arab Emirates (UAE), was sentenced today to 15 months in prison, 1 year of supervised release and restitution of $586,798. On Dec. 19, 2013, Aminzada pleaded guilty to introducing misbranded drugs into the United States.
Dana J. Boente, United States Attorney for the Eastern District of Virginia; Antoinette V. Henry, Special Agent in Charge of the Food and Drug Administration's (FDA) Office of Criminal Investigations; Karl C. Colder, Special Agent in Charge for the Drug Enforcement Administration's (DEA) Washington Field Division; Clark Settles, Special Agent in Charge of U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI), Washington; Gary Barksdale, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service; and M. Douglas Scott, Arlington County Chief of Police, made the announcement after sentencing by U.S. District Judge Claude M. Hilton.
According to court documents, Aminzada, a U.S. citizen, was the owner and operator of several companies based in Canada, the UAE and Afghanistan. Through these companies, Aminzada obtained chemotherapy and cosmetic drugs intended for Middle Eastern markets and sold those drugs to Gallant Pharma, an unlicensed wholesale drug distributor based in Arlington, Virginia, for resale in the United States. Aminzada used an employee in Pakistan to alter the drugs' packaging and hide evidence of their foreign source. In one e-mail exchange with Aminzada, the employee complained he was unable to keep "cold chain" chemotherapy drugs refrigerated—which is required to protect drug efficacy and patient health and safety—because the electricity in Peshawar, Pakistan kept going out.
Aminzada also was the source of vials of tampered Botox that were missing safety caps, contained an unusual jelly-like substance and bore mismatched lot numbers and expiration dates. The tampered Botox entered the U.S. supply chain through Gallant Pharma, and some was administered to patients in New England.
To date, twelve defendants associated with Gallant Pharma have been convicted. Two additional defendants named in the indictment, Robert Wachna and Munajj Rochelle, remain fugitives and are believed to be in Canada.
This case was investigated by FDA's Office of Criminal Investigations, DEA's Group 33 Diversion Task Force, ICE-HSI and the U.S. Postal Inspection Service, with assistance from the Arlington County Police Department and Interpol. Assistant U.S. Attorneys Lindsay Kelly, Maya Song and Jay Prabhu are prosecuting the case.
A copy of this press release may be found on the website of the U.S. Attorney's Office for the Eastern District of Virginia at http://www.justice.gov/usao/vae. Related court documents and information may be found on the website of the District Court for the Eastern District of Virginia at http://www.vaed.uscourts.gov or on https://pcl.uscourts.gov.