In August 2013, the Department of Justice announced indictments of eleven people involved in running an unlicensed pharmaceutical wholesale business out of suburban Virginia. To date, seven employees of Gallant Pharma International, along with one of its co-owners have pleaded guilty to charges of importing and distributing non-FDA approved injectable medications via their unlicensed wholesale pharmacy. Gallant did not include Black Box warnings on the versions it sold, warnings of the significant risk of serious or life-threatening effects.
Gallant Pharma International first came to the attention of authorities in August, when the Department of Justice (DOJ) announced the indictments for 11 participants in the illegal importation and sale of untested, non-FDA approved pharmaceuticals. According to the DOJ press release announcing the guilty pleas of several of Gallant Pharma’s sales people, the company specialized in the importation and sale of “misbranded and non-FDA-approved intravenous chemotherapy drugs and injectable cosmetic drugs and devices” including illegally imported versions of Botox.
On November 6, 2013, the DOJ announced guilty pleas from Gallant Pharma employees that had occurred over the last month. The 4 sales people, Patricia Durr of Massachusetts, Lisa Coroniti of Pennsylvania, Harvey Whitehead of Michigan, and Michael Merriam of Toronto, all pleaded guilty to charges of distributing non-FDA approved medication, including chemotherapy drugs and cosmetic drugs, many of which were required to contain “black box” warnings concerning their temperature storage requirements. Black Box warnings are the strongest warnings issued by the FDA, which indicate that a medication has a significant risk of serious or life-threatening adverse effects. Gallant Pharma did not meet this or other FDA requirements in the versions they sold, reports the DOJ.
Additionally, two office managers, Robert Sparks and Tanya Smith of Virginia, pleaded guilty to charges of introducing misbranded drugs into interstate commerce, reports the DOJ.
Gallant Pharma International’s co-owners, Talib Khan of Canada and Syed Huda of Virginia, have also pleaded guilty to charges of “importation fraud, selling misbranded drugs, distributing prescription drugs without a license, and wire fraud,” according to the DOJ press release on the occasion of Huda’s guilty plea. Huda also pleaded guilty on behalf of the corporation, agreeing to charges that Gallant Pharma International was guilty of “two counts of importation fraud, five counts of selling misbranded drugs, and five counts of distributing prescription drugs without a license,” reports the DOJ.
“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,” stated Acting United States Attorney Dana J. Boent on the occasion of Huda’s guilty plea.
Said Special Agent in Charnge Antoinette V. Henry, “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.”
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.