Federal authorities have torn down another pillar in a wide-ranging business that sourced foreign-made cancer and other drugs and sold them to U.S. doctors at a discount. Some of the meds were cold-chain drugs that should have been carefully transported but were sometimes left unrefrigerated in Pakistan, where their packaging was being changed to hide their provenance.
According to the FDA, Mirwaiss Aminzada, 44, a key supplier for Arlington, VA-based Gallant Pharma, has been sentenced to 15 months in prison and a year of supervised release, as well as being ordered to pay nearly $587,000 in restitution. According to the agency, Aminzada is a U.S. citizen but lived in Montreal, Quebec, and Dubai in the United Arab Emirates. He would source drugs made for markets in the Middle East and then sell them through businesses he had in Canada.
Aminzada had an employee in Pakistan alter the packaging so the products would not appear to be foreign-made. In an email exchange, the employee told Aminzada that he didn't have the wherewithal to keep "cold chain" chemotherapy drugs refrigerated because the electricity in Peshawar kept going out, meaning the drugs were compromised. Aminzada also sold Gallant vials of Botox that were missing safety caps and "contained an unusual jelly-like substance," the FDA said. Gallant sold them into the U.S. supply chain, and some ended up being used on patients in New England.
So far a dozen people who had a role in Gallant's business have been convicted, including some of its owners and a cancer clinic manager in St. Louis, MO, who bought some of the drugs. Two additional defendants named in the indictment, Robert Wachna and Munajj Rochelle, remain fugitives and are believed to be in Canada, the FDA said.
The theft and resale of highly prized and high-priced drugs has become a global problem. Authorities in Europe are in the midst of an investigation into the theft from Italian hospitals of cancer and other drugs, which were then diluted and resold. They have shown up with faked manifests in Britain, Finland and Germany. Testing on some vials of stolen Herceptin found they did not contain the injectable cancer drugs' active ingredient.
- here's the FDA announcement