Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
August 23, 2012
United States Attorney
Eastern District of Missouri
Contact: Jan Diltz
Public Information Officer
St. Louis, MO - James Newcomb of La Jolla, California was sentenced to 24 months of imprisonment for conspiring to distribute adulterated prescription drugs to physicians in the United States, including Town and Country, Missouri oncologist Abid Nisar.
According to his February 2012 plea agreement, Newcomb admitted that he distributed prescription drugs from foreign countries to physicians located in the United States, with the assistance of persons in Canada and the United Kingdom. These prescription drugs were not the U.S. version of these drugs that the U.S. Food and Drug Administration had approved for use in the United States. Newcomb and others marketed these drugs to U.S. doctors by offering the illegal prescription drugs at 14% - 60% off the average wholesale price of legitimate drugs in the United States, thereby saving practices an average of "40 cents on every dollar spent on oncology medications."
Newcomb further admitted that during Fall 2010, he began distributing "cold chain" cancer chemotherapy drugs, namely prescription drugs that require a uniform cold temperature during shipment, like Rituxan®, Herceptin®, and Neupogen®. For example, the U.S. labeling for Neupogen® requires storage at constant temperatures between 2° to 8°C (36° to 46°F), and cautions that the drug should not be shaken. If left at room temperature for longer than 24 hours, this drug should be discarded and not used with patients.
Newcomb learned that some doctor/customers had serious shipping problems with these "cold chain" cancer drugs. On October 13, 2010, Newcomb learned that Dr. Nisar had received a shipment of the prescription drugs marketed in the United States as Rituxan® and Herceptin®. Newcomb was informed that when this drug package arrived at the offices of Dr. Nisar after being imported from outside the United States, it contained what a nurse working at the practice described as "a gooey mess." A "gooey substance" covered the drugs in the package and one of the "cold packs" included in the box leaked or was damaged during shipment, making the boxes of the prescription drugs in the package wet and disintegrated. Later in January 2011, Newcomb admitted to sending another compromised shipment of the "cold chain" drugs marketed in the United States as Neupogen® and Rituxan® to Dr. Nisar in Missouri. These prescription cancer treatment drugs were "adulterated" under federal law in that the methods of their storage and shipment were not appropriate and did not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of these prescription drugs.
Newcomb also agreed to forfeit his interest in approximately $1.4 million dollars that was seized during the investigation at banks in the United States and the United Kingdom, and also forfeited a Land Rover automobile.
"This sentence aptly reflects the serious nature of this crime," said Special Agent in Charge Patrick J. Holland of FDA's Office of Criminal Investigations, Kansas City Field Office. "Americans must have confidence that their health care providers are receiving and administering drugs that fully comply with U.S. laws. The FDA will aggressively pursue all those who seek to profit from causing the importation and distribution of foreign drugs that are adulterated and misbranded."
This case was investigated by the Office of Criminal Investigation for the United States Food and Drug Administration and the Office of Inspector General for the United States Department of Health and Human Services, with assistance from the Defense Criminal Investigative Service of the U.S. Department of Defense.