Syed “Farhan” Huda, 38, and his wife, Deeba Mallick, 36, were among 11 people charged in a 17-count indictment unsealed in federal court today.
Prosecutors say Huda and Mallick masterminded a scheme in which they imported non-FDA-approved prescription drugs from various parts of the world, then switched the labels and sold the drugs to doctors, hospitals and medical practices across the U.S. The scheme is alleged to have generated more than $8.6 million in revenue over the past four years.
The couple and their alleged co-conspirators face various fraud and medical-related charges. They appeared before Judge John F. Anderson in Alexandria federal court today.
On its website, Gallant Pharma promotes its ability to deliver wholesale prescription drugs for “20-80% off your current supplier.”
“Due to our strong international supply chain, we are able to provide products at deep discounts compared to what you are currently paying,” the site says.
The press release about the charges, after the jump.
Seven arrests have been made in a coordinated operation spanning several states, related to the unsealing of a 17-count indictment and criminal complaint involving Gallant Pharma International Inc., an allegedly unlicensed company that is accused of distributing misbranded prescription drugs from its headquarters in Crystal City, Virginia, and an office in Springfield, Virginia. The individuals arrested were:
Syed “Farhan” Huda, 38, of Arlington, Virginia;
Deeba Mallick, 36, of Arlington, Virginia;
Anoushirvan R. Sarraf, 47, of Rockville, Maryland;
Talib Khan, 42, of Montreal, Canada, and Barbados;
Harvey Whitehead, 67, of Troy, Michigan;
Lisa Coroniti, 46, of Devon, Pennsylvania; and
Robert J. Sparks, 30, of Springfield, Virginia.
Munajj Rochelle, 36, a dual U.S.-Canadian citizen, is currently incarcerated in Montreal, Canada, on unrelated charges. Arrest warrants have been issued for the remaining three defendants, Robert Wachna of Ottawa, Canada, Mirwaiss Aminzada, 43, of Montreal, Canada, and Patricia Durr, 49, of Hopkington, MA.
Neil H. MacBride, United States Attorney for the Eastern District of Virginia, Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations, Gary Barksdale, Inspector in Charge of the Washington Division of the United States Postal Inspection Service, and Special Agent in Charge John P. Torres, U.S. Immigration and Customs Enforcement (ICE), Homeland Security Investigations (HSI) Washington, made the announcement after the four defendants arrested in the Eastern District of Virginia – Huda, Mallick, Sarraf, and Sparks – made their initial appearances before Judge John F. Anderson.
According to the 17-count indictment unsealed today, Khan and Huda were principals of Gallant Pharma, which allegedly began illegally importing prescription drugs, including intravenous chemotherapy drugs and injectable cosmetics, into the United States in or around August 2009. Gallant Pharma represented itself as a “Canadian company” and told potential customers that it sold drugs from Canada. The indictment alleges, however, that Khan, with the assistance of Huda, Mallick, Aminzada, and others, acquired drugs from other parts of the world, including India, Switzerland, and Turkey. These drugs were allegedly not manufactured and packaged in accordance with FDA requirements and, in some cases, were not approved by the FDA for use in the United States. The indictment states that Gallant Pharma imported the drugs with the assistance of co-conspirators in Canada and the United Kingdom, including Aminzada, who broke large shipments into many small packages, mislabeled the contents of packages, and addressed deliveries to Dr. Sarraf at his medical practice in McLean, Virginia, in order to lessen scrutiny by Customs and Border Protection. Initially, Gallant Pharma allegedly operated out of the apartment of Huda and his wife, Mallick, in Crystal City, where Huda is alleged to have served as the day-to-day head of Gallant Pharma in the United States and Mallick had primary responsibility for processing sales invoices and customer payments. Until June 2013, Gallant Pharma allegedly stored the misbranded drugs at an office in Springfield, Virginia.
According to the indictment, Gallant Pharma was not licensed to distribute prescription drugs in the United States. Nonetheless, Gallant Pharma is alleged to have sold drugs to doctors, hospitals, and medical practices across the United States, generating more than $8.6 million in revenue since August 2009. Gallant Pharma allegedly employed a cadre of sales representatives with dedicated sales territories across the United States.
The defendants are charged with the following offenses: conspiracy to commit importation fraud, introduction of misbranded drugs into interstate commerce, unlicensed medical wholesaling, wire fraud, and to defraud the FDA, each of which is punishable by a maximum term of imprisonment of five years; importation contrary to law, which is punishable by a maximum term of imprisonment of twenty years; introduction of misbranded drugs into interstate commerce, which is punishable by a maximum term of imprisonment of three years; unlicensed medical wholesaling, which is punishable by a maximum term of imprisonment of three years; wire fraud, which is punishable by a maximum term of imprisonment of twenty years; and monetary transactions with criminally derived proceeds, which is punishable by a maximum term of imprisonment of ten years.
The investigation was conducted by FDA Office of Criminal Investigations, Drug Enforcement Agency Group 33 Diversion Task Force, Department of Homeland Security Office of Immigration and Customs Enforcement, the United States Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States Attorneys Lindsay A. Kelly, Alexander T.H. Nguyen, and Ryan K. Dickey are prosecuting the case on behalf of the United States.
Criminal indictments are only charges and not evidence of guilt. A defendant is presumed to be innocent until and unless proven guilty.