Ex-CEO of Indiana drug company gets 3 years for defrauding FDA, tampering with drugs: prosecutors
A former CEO of an Indiana drug company who has been convicted of defrauding the Food and Drug Administration (FDA) and tampering with drugs will spend nearly three years behind bars, federal prosecutors said Thursday.
Paul J. Elmer, 68, wept Wednesday as his sentence was handed down, The Indianapolis Star reported.
“I’m truly thankful no one was severely injured or died,” Elmer reportedly told U.S. District Judge James Sweeney II. “I put many at risk, including patients and employees. And I am sorry.”
Elmer, who was Noblesville-based Pharmakon Pharmaceuticals’ owner and chief executive, was convicted in April in federal court in Indianapolis.
Prosecutors say an employee received notices indicating painkillers Pharmakon produced were either under- or over-potent. She told Elmer, who allegedly didn’t alert customers and didn’t recall the drugs.
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Prosecutors say it led to powerful painkillers being shipped across the country and being given to infants who suffered “serious adverse events.”
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At least one of those infants had to be revived with Narcan – used for treating drug overdoses – before being taken to a neonatal intensive care unit, The Star said.
The Associated Press contributed to this report.
Source : Bradford Betz Link