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Kenneth D. Nahum, Illegal Importation of Unapproved Chemotherapy Drugs, New Jersey 2011

NEWARK, N.J. – In a shocking case of medical malfeasance, a Monmouth County doctor, his oncology practice, and his wife have agreed to pay $1.7 million to resolve allegations that they illegally imported and used unapproved chemotherapy drugs from foreign distributors and illegally billed Medicare, U.S. Attorney Paul J. Fishman announced today.

According to the allegations, Dr. Kenneth D. Nahum, his oncology practice, and his wife, Ann Walsh, ordered cancer drugs from a foreign distributor from April 1, 2010, until January 31, 2011. These drugs had not been approved by the FDA for sale in the United States. Doctors at the practice allegedly injected the drugs into their patients, and the practice then submitted claims to Medicare for reimbursement for the drugs and infusion services.

The settlement announced today resolves allegations that the illegal importation of drugs by Nahum, his practice, and Walsh put patients at risk of serious harm from contaminated or counterfeit products. Illegally imported drugs avoid the FDA’s rigorous oversight and manufacturing standards, U.S. Attorney Fishman said.

“Patients receiving cancer treatment drugs should be assured that the medications meet FDA’s standards for safety and quality,” Jeffrey J. Ebersole, special agent in charge, FDA Office of Criminal Investigations’ New York Field Office, said. “OCI will continue its vigilance over the prescription drug supply chain to ensure that the drugs reaching patients comply with federal law, and that those who attempt to circumvent the agency’s oversight will be brought to justice.”

The settlement is a result of a lengthy investigation by the FDA’s Office of Criminal Investigation, under the direction of Special Agent in Charge Ebersole, and special agents of the U.S. Department of Health and Human Services – Office of the Inspector General, under the direction of Special Agent in Charge Scott J. Lampert.

U.S. Attorney Fishman credited the special agents with the investigation leading to today’s settlement. The government is represented by Assistant U.S. Attorneys Sarah Wolfe of the U.S. Attorney’s Office in Trenton, and Andrew A. Caffrey III and Charles Graybow of the U.S. Attorney’s Office Health Care and Government Fraud Unit in Newark.

The claims settled by this agreement are allegations only, and there has been no determination of liability. Nahum, his practice, and Walsh have agreed to pay $1.7 million to resolve the allegations. The total amount includes $1.5 million in civil penalties and $200,000 in damages.

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