Inspections, Compliance, Enforcement, and Criminal Investigations
August 8, 2011: Laurel Oncologist Pleads Guilty to Purchasing Misbranded Drugs
Used Drugs Not Approved by the FDA to Treat Cancer Patients in Order to
Benefit from Cost Savings of at Least $790,600 in Just One Year
Greenbelt, Maryland - Isabella Martire, M.D., age 52, of Laurel, Maryland, an oncologist in solo practice in Laurel, pleaded guilty to introducing a misbranded drug into interstate commerce.
The guilty plea was announced by United States Attorney for the District of Maryland Rod J. Rosenstein; Special Agent in Charge Antoinette V. Henry of the Food & Drug Administration –
Office of Criminal Investigations, Metro Washington Field Office; and Special Agent in Charge Nicholas DiGiulio, Office of Investigations, Office of Inspector General of the Department of Health and Human Services.
According to Dr. Martire’s plea agreement, in 2010, federal law enforcement investigators began investigating a pharmaceutical wholesaler based in England concerning allegations that the company was importing into the United States prescription drugs approved and labeled for use only outside the United States. Further investigation revealed that Dr. Martire purchased nearly 200,000 of misbranded prescription drugs (that is, drugs not approved by the FDA for use in the United States) from the company in 2010. On May 26, 2011, agents executed a search warrant at Dr. Martire’s office and seized several boxes of misbranded drugs purchased from the company. The labels on some of the boxes and their packaging inserts were almost entirely in Turkish.
In 2010 and early 2011, Dr. Martire used the misbranded drugs from the company to treat her cancer patients. She sought reimbursement from Medicare, Medicaid, TRICARE, federal employee health benefit plans and private health insurers for reimbursement of the cost of those drugs. The cost savings Dr. Martire realized by purchasing the misbranded drugs was at least $790,600 in 2010.