Pharma CEO jailed for distributing super-strength drugs
A former pharmaceutical CEO was last Thursday sentenced to 33 months in prison by an Indiana federal court for distributing “adulterated” drugs, including sedatives and opioids which were administered to infants.
Judge James Sweeney of the US District Court for the Southern District of India handed down the sentence against Paul Elmer, former CEO and president of Pharmakon Pharmaceuticals, who in April this year was found guilty of defrauding the US Food and Drug Administration (FDA) and distributing adulterated pharmaceuticals.
Pharmakon, which was founded by Elmer, distributed intravenous drugs to military and civilian hospitals in the US, prosecutors said.
According to the US Department of Justice (DoJ), between 2013 and 2016 Pharmakon
“routinely shipped compounded drugs to hospitals without having received laboratory test results that verified that the drugs were their purported strengths”.
At trial, FDA consumer safety officers testified that during a 2014 inspection, they discovered that Pharmakon had supplied midazolam, a sedative used to treat premature infants, at 200% the normal potency.
Prosecutors said that Pharmakon had also supplied 2,460% super-potent morphine sulfate to hospitals in Indiana and Chicago.
The opioid pain medication was administered to infants, causing overdose. One infant had to be revived by the administering of Naloxone.
Elmer, and the company’s former compliance director Caprice Bearden, interfered with and obstructed FDA inspections, prosecutors said.
Bearden was sentenced to five months in prison and three years of supervised release in April this year after she pled guilty to all charges. Elmer will serve an additional one year of supervised release.
Josh Minkler, US attorney for the Southern District of Indiana, said that “pharmaceutical manufacturers, such as Pharmakon, have a duty to ensure they are producing drugs that are formulated correctly and are safe for public consumption”.
Catherine Hermsen, director of the FDA office of criminal investigations, said that the production of unsafe drugs puts patients “at risk and is particularly concerning when they reach already vulnerable populations such as premature infants”.
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