May 21, 2018: Oncologist and Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs
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Food and Drug Administration
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U.S. Department of Justice Press Release
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For Immediate Release | United States Department of Justice Northern District of New York |
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ALBANY, NEW YORK - Vincent Koh, M.D., age 73, and his wife and office manager Milly Koh, age 64, of Poughkeepsie, New York, were sentenced today to pay fines of $7,500 and $3,000, respectively, for receiving in interstate commerce and delivering misbranded drugs, a misdemeanor.
The Kohs each pled guilty on November 20, 2017. According to their plea agreements, Vincent Koh is a New York State-licensed medical doctor specializing in the treatment of cancer patients, with offices in Poughkeepsie and Glen Falls, New York. Milly Koh managed the practice, and is responsible for ordering the drugs that Vincent Koh prescribes. From July 2010 through March 2012, the Kohs ordered various discount oncology drugs from foreign sources that Vincent Koh prescribed and administered to patients. These drugs had not been approved by the FDA for distribution or use in the United States, and their labeling did not contain information required by law. As such, these prescription drugs were “misbranded” and illegal to receive and provide to patients in the United States. Vincent Koh and Milly Koh admitted that they regularly ordered and delivered to patients a prescription drug labeled “Mabthera.” Generally, “Mabthera” contains rituximab, the same active ingredient found in the FDA-approved drug legally used and marketed in the United States as “Rituxan.” However, the drug ordered by Vincent Koh and Milly Koh came from an unapproved, foreign source, and its label did not bear adequate directions for use and other information required by the FDA. The criminal case was investigated by the FDA Office of Criminal Investigations and HHS-OIG, and was prosecuted by Assistant U.S. Attorney Joseph A. Giovannetti. In February 2018, the Kohs agreed to pay $500,000 for violating the False Claims Act by knowingly submitting false claims to Medicare for unapproved chemotherapy drugs. The civil investigation and settlement were the result of a coordinated effort among the U.S. Attorney’s Office for the Northern District of New York, HHS-OIG, FDA’s Office of Chief Counsel, and FDA’s Office of Criminal Investigations. The United States was represented in the civil investigation by Assistant U.S. Attorney Adam J. Katz. Topic(s): Consumer Protection False Claims Act Component(s):