________ A to Z kerala .......... [kvk]
New York: A US court has sentenced an Indian oncologist and his wife for using unapproved chemotherapy medications at their cancer institute for three years.
Anindya Kumar Sen (65) and his wife, Patricia Posey Sen (66), of Tennessee were sentenced by US District Judge Ronnie Greer on charges of introducing misbranded drugs into the market in violation of the Food, Drug, and Cosmetic Act (FDCA).
Sen was sentenced to three years of probation and was ordered to pay a fine of USD 100,000, while his wife was sentenced to four years of probation and ordered to pay a fine of USD 200,000.
According to evidence presented at trial, the couple purchased over USD 3 million in misbranded and unapproved chemotherapy and chemotherapy supportive medications between April 2009 and March 2012.
Sen's wife, who was also his practice manager, purchased the drugs through a Canadian business which obtained the drugs through a UK-based distributor.
The drugs were not approved by the Food and Drug Administration (FDA) for distribution and use in the United States and had been distributed in Turkey, India, and Europe.
Many of the drugs had names different from the drugs approved for use in the US. Patricia Sen told employees that she was purchasing drugs from clinical care because the drugs were cheaper.
Evidence presented showed that the Sens received approximately 1.3 million dollars in additional profit by purchasing the unapproved drugs.
Under the conditions of probation, Sen must perform 100 hours of community service and his wife must perform 200 hours of community service.
Sen must also develop protocols to ensure regulatory compliance and provide those protocols to his probation officer as well as submit his practice for inspection by his probation officer to review records of drugs purchased.
His wife has been prohibited from working in any medical practice without the permission of her probation officer and from being involved in the ordering of any prescription drugs.
Patricia was also ordered to serve 48 hours in jail as a condition of probation.
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