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The owner of Indiana-based Pharmakon Pharmaceuticals is charged with distributing adulterated drugs and lying to the FDA.
The Department of Justice is charging the owner and director of compliance for Noblesville, IN based compounding pharmacy Pharmakon Pharmaceuticals for interfering with an FDA investigation.
The charges come at time of increased public scrutiny regarding compounding pharmacy, following the trial of NECC owner Barry Cadden, who was sentenced to nine years in prison for his role in a fungal meningitis outbreak.
Related article: How the NECC Case Changed Compounding Pharmacy
The DOJ indictment lists several violations attributed to Paul J. Elmer, President and Owner, and Caprice R. Bearden, Director of Compliance. According to the indictment, Elmer and Bearden oversaw and then attempted to cover up the compounding and distribution of adulterated drugs.
As with other compounding pharmacies, the drugs were sent off for quality testing. Between July 2013 and February 2016 were flagged over 70 times for being over or under potent. According to the indictment, Bearden discussed the findings with Elmer, who “determined that Pharmakon should not contact any individuals and entities-including physicians and hospitals who received the drugs, nor conduct any product recalls before FDA intervention, because the health care providers had likely already used the drugs, and because notification would lead to the loss of customers, and, therefore, a loss of profit.”
In February of 2016, the pharmacy distributed 2,460% potent morphine sulfate, which was given to three infants, one of whom was taken by emergency helicopter to a children’s hospital. That lot was recalled. Before that incident, they had not notified the FDA or consumers at any point regarding potency failures.
During this time, the FDA examined the Pharmakon facilities on three separate occasions. In their last visit in May of 2016, the FDA found multiple safety violations including wearing street clothes not covered by sterile clothing and other sanitary problems. For the FDA, however, the most pressing issue was that the pharmacy sent out the products before the test results came in. In the March 2014 and May 2016 inspections, the pharmacy allegedly lied to the FDA, telling the agency that the pharmacy had not received any out-of-specification results.
The DOJ alleged that Bearden and Elmer “sought to thwart the FDA's efforts to learn about the extent of and causes of the potency failures.”
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“Companies that do not meet federal manufacturing standards, especially when dealing with highly potent drugs like fentanyl meant for vulnerable populations, put the health and safety of American consumers at great risk,” said FDA Commissioner Scott Gottlieb, M.D. “The FDA and our Office of Criminal Investigations will continue to pursue and help bring to justice those companies who put the public health at risk.”
Both Elmer and Bearden were charged with one count of conspiracy to defraud the United States, three counts of distributing an adulterated drug in interstate commerce, and six counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. The conspiracy charge can carry a maximum charge of five years in prison, and a fine of $250,000 or twice the gross gain or loss gained from the offense.
The trial is scheduled for August 21.