Feds Accuse 'Greedy' Pharmakon Execs of Selling Drugs That Sickened Babies

Feds Accuse 'Greedy' Pharmakon Execs of Selling Drugs That Sickened Babies June 23, 2017
By Alex Keown, BioSpace.com Breaking News Staff

NOBLESVILLE, Ind. – Two executives at Pharmakon Pharmaceuticals, Inc. a drug compounder, face multiple federal charges for failing to pull painkillers that were reportedly 25-times stronger than indicated and resulted in the illness of three infants.

Federal authorities said Paul J. Elmer, owner of Pharmakon, and Caprice R. Bearden, the company director of compliance, put “greed” ahead of the wellness and safety of people. According to the government from July 2013 to mid-February 2016, it received more than 70 potency test failure notices from companies used by Pharmakon to test for potency. Those notices indicated that drugs such as morphine sulfate and fentanyl were either under- or over-potent, the government said in its indictment. Furthermore, the indictment said the two Pharmakon executives decided they should not contact any entity or individual using their products, including hospitals, about the failure notices. The Pharmakon executives did not issue any recalls until the FDA issued a warning letter in 2015, the indictment said.

Despite that warning letter, Pharmakon continued to distribute drugs that had questionable potency. According to the federal indictment in early February 2016, Pharmakon distributed “over potent morphine sulfate,” an opioid used to treat chronic pain, to a hospital in Indiana and a hospital in Illinois. Three infants received the too-strong doses of morphine sulfate and suffered “serious adverse events.” One child had to be air-lifted to a nearby children’s hospital for additional treatment.

The indictment also said that during inspections of the Pharmakon facility by the U.S. Food and Drug Administration, Bearden lied about receiving the “out-of-specification drug potency test results.” Additionally the indictment said Elmer knew of the lies and did nothing to correct the situation. The indictment alleges that Elmer and Bearden conspired to defraud the United States by interfering with and obstructing the lawful functions of the FDA, and obstructing, influencing and impeding FDA inspections. During the 2016 inspection, Elmer directed at least one Pharmakon employee to backdate batch records of compounded drugs, the government said in its indictment.

“These defendants put greed and the reputation of their company ahead of the health and safety of our most innocent victims,” U.S. Attorney Josh Minkler for the Southern District of Indiana said in a statement. “Their actions put lives in danger and they will be held accountable.”

During two FDA inspections of the facility, regulatory agents observed conditions that did not comply with FDA regulations. The indictment said Pharmakon did nothing to correct those issues, or did the company investigate the root causes of the potency problems. The executives also failed to make changes in Pharmakon’s compounding operations to reduce the incidence of these failures, the indictment said, and opted for a business-as-usual attitude.

Elmer and Bearden face a 10-charge indictment 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. Elmer pleaded not guilty and has a trial scheduled for Aug. 21.
 

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