California woman sentenced for distributing adulterated cancer drugs from overseas to Missouri doctor Abid Nisar and others
St. Louis, MO - SANDRA L. BEHE of La Jolla, California, was sentenced to five years of probation and 200 hours of community service for distributing adulterated prescription drugs to physicians in the United States, including Town and Country, Missouri, doctor Abid Nisar.
In her plea agreement, Behe admitted that she and others caused the distribution of adulterated cancer chemotherapy prescription drugs from foreign countries to Dr. Nisar and other oncologists located in the United States. As disclosed by Court documents, during Fall 2010, Behe and others began distributing "cold chain" prescription drugs that required a uniform cold temperature during shipment, including the drugs marketed in the United States as Neupogen®, Herceptin® and Rituxan®. The U.S. labeling for these drugs requires that they be stored and shipped at constant temperatures between 2° to 8°C (36° to 46°F), and cautions that the drugs should not be shaken or frozen.
In her plea agreement, Behe admitted that on October 13, 2010, Dr. Nisar received a shipment of the prescription drugs marketed in the United States as Rituxan® and Herceptin® from her and others. Dr. Nisar’s drug shipment was warm upon arrival from overseas, and contained what a nurse working at the practice described as "a gooey mess," with a "gooey substance" covering two prescription drug boxes from this package. One of the "cold packs" included in the box had leaked or was damaged during shipment, making the boxes of the prescription drugs in the package wet and disintegrated. Behe agreed that these drugs were illegal and "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.
"As this case shows, introducing foreign, unapproved pharmaceuticals into the U.S. market can lead to the distribution of adulterated drugs to physicians who treat especially vulnerable patients" said Patrick J. Holland, Special Agent in Charge of the Kansas City Field Office of the FDA's Office of Criminal Investigations. "FDA and our law enforcement partners are committed to pursuing the prosecution of those who violate federal laws by causing adulterated drugs, misbranded drugs or unapproved new drugs to be distributed from foreign sources to physicians in the U.S."
Behe was previously employed by Ban Dune Marketing, Inc. (BDMI) of La Jolla, California. Behe’s co-defendant in this case, James Newcomb, was the owner, founder and president of BDM. Newcomb is set to be sentenced on July 6, 2012. BDMI and its employees have been the subject of several safety alerts and letters from FDA, which can be found at www.FDA.gov, including "Another counterfeit cancer medicine found in the United States – Illegal practice puts patients at risk" on April 3, 2012, and “Letters to Doctors about Risks of Purchasing Medications from Foreign or Unlicensed Suppliers" dated April 16, 2012.
Dr. Abid Nisar previously paid the United States $1,000,336 to resolve allegations that he submitted false claims for payment to the Medicare, TRICARE, Illinois Medicaid and MO HealthNet (formerly known as Medicaid) programs for assorted misbranded cancer treatment drugs. In the agreement, Dr. Nisar also was excluded from future participation in federal health care programs for seven years.
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.