Office Manager For Chattanooga Cancer Treatment Center Pleads Guilty To Ordering Drugs Not Approved By The FDA

Tuesday, August 2, 2016

The office manager for a Chattanooga cancer treatment center on Tuesday pleaded guilty to ordering drugs from overseas that were not approved by the Food and Drug Administration.

Karen Chamberlain, 62, appeared before Magistrate Chris Stegner.

The charge of use of "misbranded" drugs is a misdemeanor subject to up to a year in prison.

Prosecutor Perry Piper said Ms. Chamberlain was the office manager for Chattanooga Gyn-Oncology, 1000 East Third Street, Suite 201, that provided care and treatment for patients with cancer and other diseases.

He said Ms. Chamberlain "was responsible for ordering medications for the practice. As part of the treatment of patients for cancer and other diseases, the defendant purchased drugs which were used by Chattanooga Gyn-Oncology. Through investigations, agents with the Food and Drug Administration (FDA) learned that Chattanooga Gyn-Oncology was obtaining drugs which were 'misbranded.'

”A drug is 'misbranded' if it was manufactured, prepared, propagated, compounded, and processed in an establishment not duly registered with FDA. A drug is also 'misbranded' if it came from a domestic or foreign drug establishment and that drug was not annually listed with the FDA by the establishment as one of the drugs which was being manufactured for commercial distribution in the United States at that drug establishment.

"The drugs being procured by Chattanooga Gyn-Oncology through the defendant were obtained from Quality Special Products (QSP) in Winnipeg, Canada. Quality Specialty Products was a business in Winnipeg, Canada, offering for sale to physicians and other health care providers in the United States drugs which had been obtained from foreign sources and which had not been approved by the U.S. Food and Drug Administration for distribution or use in the United States."

The prosecutor said Ms. Chamberlain was interviewed on May 7, 2012. She "admitted to agents that she had purchased drugs from QSP (drugs which were later used in the clinic), that she knew that QSP was located in Canada, and further that the drugs she ordered from QSP were originating in Great Britain. The defendant stated that she purchased from QSP because their prices were lower."

He said Ms. Chamberlain stated that “she had been the office manager for the past 25 years and did not know she was doing something wrong when she was buying from the foreign source.”

One of the misbranded drugs obtained by the clinic was Taxotere, a drug used to treat cancer. Agents with the FDA submitted some of the recovered drugs to the FDA laboratory and the laboratory reported that the drugs recovered from the defendant contained the same active ingredient as approved drugs, it was stated.


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