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Press Release
Press Release
Company smuggled and sold over $12 million in non-FDA-approved chemotherapy drugs and injectable cosmetic drugs and devices
ALEXANDRIA, Va. – Talib Khan, 43, of Montreal, Quebec and Barbados, co-founder of Gallant Pharma International Inc., an unlicensed wholesale drug distributor headquartered in Arlington, Va., was sentenced today to 3 years in prison, 2 years of supervised release, and $3.4 million in forfeiture and restitution to victims.
Dana J. Boente, Acting 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; Gary Barksdale, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service; Scot R. Rittenberg, Acting Special Agent in Charge of U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI), Washington; and M. Douglas Scott, Arlington County Chief of Police, made the announcement after sentencing by United States District Judge Claude M. Hilton.
On Oct. 15, 2013, Khan pleaded guilty to conspiracy and sale of misbranded drugs. According to court documents, 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 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 also were 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.
Also sentenced today was Gallant Pharma sales representative Harvey Whitehead, 68, of Cadillac, Michigan. Whitehead, was sentenced to 2 years of probation, to include 6 months of home confinement, following his Oct. 3, 2013 guilty pleas to unlicensed wholesale prescription drug distribution and sale of misbranded drugs. Whitehead also agreed to pay $36,795.85 in restitution to victims.
Nine additional co-defendants, including co-founder Syed “Farhan” Huda, 38, of Arlington, Va., previously pleaded guilty, and eight are awaiting sentencing. A jury trial is scheduled for March 31, 2014, for alleged co-conspirators Anoushirvan Sarraf, 48, and Eva Montejo Pritchard, 48, both of Rockville, Md. Sarraf, the owner of Aphrodite Skin Care Clinic in McLean, Va., and Pritchard, the office manager, are alleged to have knowingly received illegal shipments intended for Gallant Pharma, in exchange for a discounted price on non-FDA-approved drugs and devices that they used on Aphrodite patients without the patients’ knowledge or consent.
This case was investigated by FDA’s Office of Criminal Investigations, the Drug Enforcement Agency’s Group 33 Diversion Task Force, HSI Washington and the U.S. Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States 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 United States 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.