MAY 09 (ALEXANDRIA, Va.) – Gallant Pharma International Inc. (Gallant Pharma), an unlicensed wholesale drug distributor headquartered in Arlington, Virginia, that distributed more than 17,000 units of non-FDA approved cancer and cosmetic drugs to doctors across the United States, was sentenced today to pay $3.4 million in forfeiture and restitution. On Dec. 2, 2013, Gallant Pharma pleaded guilty to two counts of illegal importation, five counts of introducing misbranded drugs and five counts of unlicensed prescription drug wholesaling.
Syed “Farhan” Huda, 39, formerly of Arlington, Virginia, co-founder and co-owner of Gallant Pharma, was sentenced today to 36 months in prison, followed by two years of supervised release. Huda also was ordered to pay $3.4 million in forfeiture and restitution to victims. On Dec. 2, 2013, Huda pleaded guilty to illegal importation, introducing misbranded drugs, unlicensed medical wholesaling and wire fraud.
Also sentenced today was Gallant Pharma office manager Deeba Mallick, 37, the wife of co-owner Huda. Mallick was sentenced to nine months in prison, one year of supervised release and a $75,000 fine. Mallick pleaded guilty on Dec. 19, 2013 to misprision of a felony.
Karl C. Colder, Special Agent in Charge for the Drug Enforcement Administration’s (DEA) Washington Field Division; 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; Katrina W. Berger, Acting Special Agent in Charge, U.S. Immigration and Customs Enforcement’s (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 the sentencings by U.S. District Judge Claude M. Hilton.
According to information made public in court, between August 2009 and August 2013, Gallant Pharma smuggled into the United States and sold more than $12.4 million in non-FDA approved chemotherapy drugs and injectable cosmetic drugs and devices, generating profits of $3.4 million. Many of these drugs were subject to strict temperature controls to protect drug potency. Gallant Pharma shipped and received such drugs with ice packs, not dry ice as used by legitimate distributors, and on at least one occasion, a shipment containing such drugs took more than two weeks to arrive in Virginia from overseas during a July 2012 heat wave. Many drugs sold by Gallant Pharma were also required to carry a FDA “black box” warning, which indicates that a drug carries a significant risk of serious or life-threatening adverse effects. The versions sold by Gallant Pharma did not meet this or other FDA labeling requirements.
On Tuesday, co-conspirators Anoushirvan Sarraf, 48, and Eva Montejo Pritchard, 48, both of Rockville, Maryland, were convicted by a federal jury for their involvement in the scheme. Sarraf, a licensed doctor and the owner of Aphrodite Skin Care & Esthetic Clinic in McLean, Virginia, and Pritchard, Aphrodite’s office manager, received hundreds of shipments addressed to Aphrodite, containing illegal importations intended for Gallant Pharma, in exchange for a deeply discounted price on non-FDA approved drugs and devices. While cancer drugs were always handed off to Gallant Pharma, the defendants kept many of the non-FDA approved cosmetic drugs and devices, which were used on Aphrodite patients without the patients’ knowledge or consent.
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 DEA’s Group 33 Diversion Task Force FDA’s Office of Criminal Investigations, ICE-HSI and the U.S. Postal Inspection Service, with assistance from INTERPOL and the Arlington County Police Department. Assistant U.S. Attorneys Lindsay Kelly, Maya Song and Jay Prabhu are prosecuting the case on behalf of the United States.
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.