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Doctor Cleared in FDA Drug Case
Doctor Cleared in FDA Drug Case
Bringing Justice to a Doctor and His Wife Wrongfully Convicted for Using Life-Saving Cancer Drugs
In 2013, federal prosecutors charged Dr. Anindya Kumar Sen and his wife with introducing misbranded chemotherapy drugs into interstate commerce. Though the medications were real and administered to cancer patients, they were sourced from foreign distributors not approved by the FDA. A jury convicted them on 29 misdemeanor counts, and the court imposed $300,000 in fines and probation.
Attorney Alex Little led the appellate effort, arguing that the Food, Drug, and Cosmetic Act (FDCA) was never intended to criminalize physicians operating in good faith. He highlighted that Dr. Sen had no intent to violate federal law, that prosecutors improperly relied on questionable evidence, and that the FDA’s enforcement strategy risked criminalizing routine clinical care.
In December 2014, the Department of Justice dropped the case entirely. All convictions were vacated, fines eliminated, and no prison time served. This landmark outcome not only cleared Dr. Sen’s name but helped safeguard medical professionals nationwide from similar prosecutions.
Key Facts
29 convictions reversed: All charges were dismissed on appeal.
$0 in fines: The $300,000 penalty was fully eliminated.
0 jail time: Neither defendant served a single day in custody.
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