Drugs

Pharmakon Employees Charged in Drug Potency Case

An Indiana compounding pharmacy owner and compliance director have been charged criminally in connection with their distribution of over- and under-potent drugs, and defrauding the U.S. by interfering with and obstructing FDA’s lawful duties, according to the Department of Justice (DoJ). Pharmakon Pharmaceuticals’ Paul J. Elmer (Fishers, IN) and Caprice R. Bearden (Carmel, IN) were charged in a 10-count indictment.

“The distribution of over- and under-potent drug products poses a serious risk of harm to patients,” the government says. “FDA’s efforts to ensure the safety of compounded drugs is critically important. Impeding FDA’s ability to do its job and uncover these types of safety concerns will not be tolerated. The Justice Department is committed to working with FDA to protect patients and ensure compounded drugs are safe.”

DoJ alleges that from 7/2013 through 2/2016, Bearden received about 70 potency test failure notices from companies used by Pharmakon to test for potency, indicating that drugs such as morphine sulfate and fentanyl were either under- or over-potent.“Bearden discussed the out-of-specification test results with Elmer, a licensed pharmacist, and until Pharmakon compounded over-potent morphine sulfate in 2/2016, Elmer determined that Pharmakon should not contact any individuals or entities — including hospitals — who received the drugs, nor conduct any product recalls before FDA intervention.”

DoJ further contends that during FDA inspections of Pharmakon in 2014 and 2016, Bearden lied about the company never having received any out-of-specification drug potency test results. According to the indictment, Elmer learned of Bearden’s lies during or shortly after FDA’s inspections and took no action to correct her and to inform the agency FDA of the extent of Pharmakon’s drug potency failures. The indictment alleges that Elmer and Bearden conspired to defraud the U.S. by interfering with and obstructing the lawful functions of FDA, and obstructing, influencing and impeding FDA inspections.

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