California woman pleads guilty to distributing adulterated cancer drugs from overseas to Town and County doctor
St. Louis, MO - The United States Attorney’s Office announced today that SANDRA L. BEHE, of La Jolla, California, pled guilty today to one count of distributing adulterated prescription drugs to physicians in the United States, including local Missouri doctor Abid Nisar. Sentencing is set for May 25, 2012.
According to her plea agreement, Behe admitted that she and others caused the distribution of 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, and their labeling did not contain National Drug Codes and other information from the U.S. labeling for these drugs. The exterior shipment packaging for these illegally imported drugs concealed the contents of the packages from the Government, falsely describing the contents as “medical samples” with low declared monetary values.
Behe admitted that during Fall 2010, she and others began distributing "cold chain" cancer chemotherapy drugs, namely prescription drugs that require a uniform cold temperature during shipment. Some "cold chain" drugs had high profit margins. The “cold chain” drugs imported by Behe and others included Neupogen®, a prescription drug that is typically intravenously infused into cancer patients. The U.S. labeling for this drug requires storage of the drug in a refrigerator at 2° to 8°C (36° to 46°F), and cautions that the drug should not be shaken. According to the U.S. labeling for this drug, if it is left at room temperature for longer than 24 hours, it should be discarded and not used with patients. Similarly, the FDA-approved U.S. labeling for the prescription drugs Herceptin® and Rituxan® requires that these drugs be kept at a constant temperature between 36 and 46 degrees Fahrenheit, and not shaken or frozen.
In her plea agreement, Behe admitted that on October 13, 2010, she learned that a Missouri doctor had received a shipment of the prescription drugs marketed in the United States as Rituxan® and Herceptin® from her and others. Behe was informed that when this drug package arrived at the offices of Dr. Nisar in Missouri 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 two prescription drug boxes from this package, as 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. Behe admitted that these 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.
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.