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May 21, 2018: Oncologist & Office Manager Sentenced in Connection with Administering Unapproved, Foreign Drugs


OCI Small Clear Seal 

 

Food & Drug Administration 
Office of Criminal Investigations

 

ALBANY, NEW YORK – Vincent Koh, M.D., age 73, & his wife & office manager Milly Koh, age 64, of Poughkeepsie, New York, were sentenced today to pay fines of $7,500 & $3,000, respectively, for receiving in interstate commerce & delivering misbranded drugs, a misdemeanor.

 The announcement was made by United States Attorney Grant C. Jaquith; Jeffrey Ebersole, Special Agent in Charge of the Northeast Area Office of the Food & Drug Administration (FDA), Office of Criminal Investigations; and Scott J. Lampert, Special Agent in Charge of the Office of Inspector General for the U.S. Department of Health & Human Services (HHS-OIG), New York Region.

 

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 & 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 & 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” & illegal to receive & provide to patients in the United States. 

 

Vincent Koh & Milly Koh admitted that they regularly ordered & delivered to patients a prescription drug labeled “Mabthera.” Generally, “Mabthera” contains rituximab, the same active ingredient found in the FDA-approved drug legally used & marketed in the United States as “Rituxan.” However, the drug ordered by Vincent Koh & Milly Koh came from an unapproved, foreign source, & its label did not bear adequate directions for use & other information required by the FDA. 

 

The criminal case was investigated by the FDA Office of Criminal Investigations & 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 & 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, & FDA’s Office of Criminal Investigations. The United States was represented in the civil inquiry by Assistant U.S. Attorney Adam J. Katz.

 

Topic(s): 

Consumer Protection

False Claims Act

 

Component(s): 

USAO – New York, Northern

Updated: May 22, 2018 — 5:31 pm

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