December 2, 2013: Gallant Pharma Company and Co-Owner Plead Guilty to Sixteen Charges of Prescription Drug Fraud
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
December 2, 2013
United States Attorney
Eastern District of Virginia
ALEXANDRIA, Va. - Gallant Pharma International Inc., headquartered in Arlington, Va., pleaded guilty today to two counts of importation fraud, five counts of selling misbranded drugs, and five counts of distributing prescription drugs without a license. Co-founder and co-owner Syed "Farhan" Huda, 38, of Arlington, Va., entered the guilty plea on behalf of Gallant Pharma, and he also pleaded guilty to one count each of importation fraud, selling misbranded drugs, distributing prescription drugs without a license, and wire fraud.
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; Special Agent in Charge DEA Washington Division, Karl C. Colder; Gary Barksdale, Inspector in Charge of the Washington Division of the U.S. Postal Inspection Service; Acting Special Agent in Charge Scot R. Rittenberg for U.S. Immigration and Customs Enforcement's (ICE) Homeland Security Investigations (HSI) in Washington, D.C.; and M. Douglas Scott, Arlington County Chief of Police, made the announcement after the pleas were accepted by United States District Judge Claude M. Hilton.
"Gallant Pharma exploited some of our most vulnerable citizens to make a profit, including those suffering from cancer and undergoing intravenous chemotherapy. We will prosecute these cases aggressively," said Acting United States Attorney Boente. FDA Special Agent in Charge Henry added, "Gallant Pharma purchased drugs on the international black market, with no idea whose hands those drugs passed through or what conditions the drugs were stored or shipped in. FDA will continue to vigorously protect the health and safety of medical patients in the United States."
In the statements of facts filed with the plea agreements, Huda and Gallant Pharma admitted that the company sold many "cold chain" drugs, which are subject to strict temperature controls to protect drug efficacy, and shipped and received those drugs with ice packs that sometimes melted, not with dry ice used by legitimate drug distributors. Many of the drugs sold by Gallant Pharma, including Botox, were required to contain a "black box" warning, the strongest warning issued by the FDA, which indicates that a drug has 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.
Huda is the eighth member of Gallant Pharma to enter a guilty plea in this prosecution. On October 15, 2013, Gallant Pharma co-founder and co-owner Talib Khan, 42, of Montreal, Canada and Barbados, pleaded guilty to selling misbranded chemotherapy and cosmetic drugs, and conspiracy to commit importation fraud, sell misbranded drugs, distribute prescription drugs without a license, and defraud the FDA. Four Gallant Pharma sales representatives and two office managers also have entered guilty pleas for their participation in this scheme.
Huda faces a maximum penalty of 53 years' imprisonment when he is sentenced on March 28, 2014. Huda, a Canadian citizen, also faces deportation as a result of his conviction. A jury trial is scheduled for January 6, 2014, for alleged Gallant Pharma administrator (and wife of Huda) Deeba Mallick, 36, of Arlington, Va.; alleged supplier Mirwaiss Aminzada, 44, of Dubai, United Arab Emirates, and Montreal, Canada; and alleged drop-shipper and customer Anoushirvan Sarraf, 47, of Rockville, Md.
This case was investigated by FDA's Office of Criminal Investigations, the Drug Enforcement Agency's Group 33 Diversion Task Force, ICE, and the U.S. Postal Inspection Service, with assistance from the Arlington County Police Department. Assistant United States Attorneys Lindsay Kelly, Ryan K. Dickey, Jay V. Prabhu, and Maya Song 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.