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A La Jolla man admitted his role in a conspiracy to distribute unapproved chemotherapy drugs to doctors throughout the United States.
James Newcomb pleaded guilty Tuesday to selling prescription drugs that were not approved for use in the U.S.and were not the versions that had been approved by the U.S. Food and Drug Administration.
He also marketed the drugs to doctors at 14 to 60 percent off their average wholesale prices.
Newcomb admitted to sending a shipment of drugs marketed in the United States as Neupogen® and Rituxan® a Missouri doctor in January 2011.
U.S. labeling for the drugs requires storage in a refrigerator at 2° to 8°C (36° to 46°F). If left at room temperature for longer than 24 hours, these so-called “cold chain” drugs should be discarded and not used with patients.
Newcomb admitted that the storage and shipment were not as required by U.S. law.
As part of his plea, Newcomb agreed to forfeit $1.4 million in profits as well as a Land Rover.
On Thursday, Abid Nisar, M.D. of St. Louis County, Missori pleaded guilty to a federal misdemeanor for using drugs provided to him by Newcomb and another person.
Newcomb faces sentencing on May 25. The conspiracy count carries a maximum penalty of five years in prison and/or fines up to $250,000.