Former CEO sentenced to prison for defrauding FDA

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Fishers resident Paul Elmer, 68, was sentenced to 33 months in prison and ordered to pay a $25,000 fine and serve one year of supervised release after serving his prison sentence for conspiring to defraud the Food and Drug Administration and for multiple counts of distributing adulterated drugs. Elmer previously worked as the CEO and president of Pharmakon Pharmaceuticals, a drug compounding company based in Noblesville.
“Pharmaceutical manufacturers, such as Pharmakon, have a duty to ensure they are producing drugs that are formulated correctly and are safe for public consumption,” U.S. Attorney Josh Minkler stated in a press release. “The U.S. Attorney’s Office is committed to prosecuting those individuals who prioritize profit over safety and negligently compromise the integrity of their product.”

Elmer was convicted April 10 after an eight-day jury trial.

Pharmakon made and distributed compounded, sterile, intravenous drugs to military and civilian hospitals throughout the United States, and evidence at the trial showed in February 2016, Pharmakon distributed 2,460 percent super-potent morphine sulfate, an opioid pain medication, to hospitals in Indianapolis and Chicago. Nurses at the Indianapolis hospital administered the drug, not knowing that it was 2,460 percent super potent, to infants in the pediatric unit, causing three infants to suffer adverse effects. One infant needed to be revived with Narcan and sent by helicopter to a nearby hospital with a neo-natal intensive care unit.

“Producing unsafe drugs puts patients at risk and is particularly concerning when they reach already vulnerable populations such as premature infants. This conviction demonstrates that those, including drug compounders, who distribute harmful drugs will be held accountable under the law,” FDA Officer of Criminal Investigations Director Catherine A. Hermsen stated. “The FDA continues to play an important role in protecting patients — including young children — and we will continue to work with our law enforcement partners to pursue and bring to justice those who place profits before the health of U.S. patients.”


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