Counterfeiting conviction highlights danger of cold chain lapse

Federal authorities have taken down another player in the escalating counterfeit drug trade, this one for shipping foreign-made "cold chain" cancer drugs that arrived at a doctor's office as a "gooey mess."

James Newcomb, was given 24 months in federal prison after pleading guilty to charges that he shipped foreign versions of prescription drugs to doctors around the U.S. The case against the La Jolla, CA, man focused on drugs sent to St. Louis-area oncologist Abid Nisar, the FDA says in a press release. Newcomb also is forfeiting $1.4 million in cash and a Land Rover.

With help from companies in Canada and the United Kingdom, Newcomb offered the drugs to U.S. doctors at discounts of 14% to 60% off their usual wholesale prices, telling them they could save "40 cents on every dollar spent on oncology medications."

Among those were cold chain cancer chemotherapy drugs like Rituxan, Herceptin, and Neupogen, that are supposed to be shipped at uniform temperatures and are supposed to be destroyed if they have gone more than 24 hours outside of their prescribed temperatures. Reports have indicated that the drugs were Turkish versions that are not approved for sale in the U.S. But Newcomb didn't have temperature-controlled shipping and when one doctor received a shipment, the drugs were "a gooey mess" and had leaked all over the packaging, the FDA says.

Newcomb is one of a number of suspects federal authorities have arrested or convicted recently as they try to get their arms around what appears to be a burgeoning trade in counterfeits that are increasingly finding their way into the U.S.

here's the press release 

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