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Former Drug Co. CEO Facing Imprisonment For Defrauding FDA

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A federal court has sentenced the former President of drug compounding company Pharmakon Pharmaceuticals Inc. to prison for defrauding the U.S. Food and Drug Administration and distributing adulterated drugs, the U.S. Department of Justice said.

District Judge James Sweeney sentenced Paul Elmer, 68, the former president and owner of Pharmakon Pharmaceuticals Inc. to 33 months in prison. Elmer also was fined $25,000 and ordered to serve one year of supervised release upon completion of his prison sentence.

"We will not tolerate actions that impede the FDA's efforts to ensure the safety of such drugs, and we will thoroughly investigate and prosecute those who knowingly endanger patients," said Assistant Attorney General Jody Hunt of the Department of Justice's Civil Division.

Indiana-based Pharmakon, founded by Elmer, made and distributed compounded, sterile, intravenous drugs to military and civilian hospitals throughout the U.S.

In April, Elmer was convicted by a jury of one felony count of conspiracy to defraud the FDA and nine counts of adulterating or introducing adulterated drugs into interstate commerce.

According to the DOJ, Elmer was responsible for Pharmakon routinely distributing over- or under-potent compounded drugs to hospitals across the U.S.

Despite later receiving laboratory test results showing potency failures, Elmer did not recall the drugs, notify the FDA of the potency failures, or conduct any investigation to determine the cause of the potency failures.

The evidence at trial showed that Pharmakon shipped customers at least 70 lots of over- or under-potent drugs from 2013 to 2016.

Elmer is also alleged to have misled and interfered with FDA inspections of Pharmakon to prevent the agency from knowing about the potency failure of the drugs.

In one instance, Pharmakon distributed overly-potent morphine sulfate, an opioid pain medication, to hospitals in Indianapolis and Chicago. Unaware of the drugs' strength, nurses at the Indianapolis hospital administered the morphine to infants in the pediatric unit.

Three infants suffered adverse effects from the narcotic overdose. One infant needed to be revived through the administration of Naloxone and sent by helicopter to a nearby hospital with a neo-natal intensive care unit.

In April this year, Pharmakon's former compliance director Caprice Bearden was sentenced to five months in prison and three years of supervised release after she pleaded guilty to conspiracy and adulteration offenses.

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