The US regulator issued Talib Khan, co-founder of sham medicines company Gallant, with an order banning him permanently from providing services to anyone with an approved or pending drug application.
The ban follows Khan’s 2014 conviction of two felonies: one for introducing misbranded drugs into interstate commerce, and the other for criminal conspiracy. The Federal Drug & Cosmetic Act requires the FDA to debar anyone convicted of a felony related to regulation of a drug under the Act.
Gallant Pharma International Inc, which Khan co-founded and co-owned between 2009 and 2013, was “a company dedicated to the illegal importation and sale of misbranded and non-FDA approved chemotherapy drugs and injectable cosmetic drugs and devices in the US,” said the FDA.
Khan directed international drug suppliers to ship chemotherapy drugs and injectable cosmetic drugs and devices to the UK and Canada, and then arranged for the goods to be sent on to the US.
But Gallant Pharma was not licensed as a wholesaler of prescription drugs by the state of Virginia, where it operated. Additionally, some of the drugs and devices Khan sold were not approved by the FDA for use in the US.
Many of the drugs Gallant supplied were misbranded and did not contain proper packaging inserts or instructions in English. They also lacked FDA-required labelling to track the production and sale of drug batches.
When he pled guilty in 2013 to conspiracy and the sale of misbranded drugs, Khan admitted Gallant had received illegal revenue of at least $12.4m over four years. He revealed he had purchased drugs and devices from Turkey, Switzerland, the UK, UAE, and other countries.
He also hired sales representatives in the US to sell the illegal drugs. In 2009, Medicis Pharmaceutical sent a cease-and-desist letter to Talib Khan to tell him he was violating its exclusive marketing authorisation for injectable fillers Restylane and Perlane.