The owner and director of compliance of a Noblesville-based compounding pharmacy are facing federal charges for the distribution of over- and under-potent drugs. U.S. Attorney Josh Minkler says Paul Elmer and Caprice Bearden are also being charged with defrauding the United States by "interfering with and obstructing the lawful functions of the Food and Drug Administration."
The charges against Elmer and Bearden include:
- One count of conspiracy to defraud the United States
- Three counts of distributing an adulterated drug in interstate commerce
- Six counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce
Elmer was the owner and president of Pharmakon Pharmaceuticals Inc. and Bearden was the company’s director of compliance. A federal indictment alleges that between July 2013 and February 2016, Bearden received approximately 70 potency test failures from companies that stated the company’s drugs were either under-potent or over-potent.
According to the indictment, Elmer decided not to contact anyone who received the drugs, including hospitals, or conduct any recalls before the FDA intervened. In February 2016, Pharmakon allegedly distributed over-potent morphine sulfate, used to treat moderate-to-severe acute and chronic pain, to hospitals in Indiana and Illinois, after which three infants received the drug which was nearly 25 times the strength indicted on its label. One infant was later airlifted to a nearby children’s hospital as a result.
"The distribution of over- and under-potent drug products poses a serious risk of harm to patients," said Acting Assistant Attorney General Chad Readler of the Justice Department’s Civil Division. "FDA’s efforts to ensure the safety of compounded drugs is critically important. Impeding FDA’s ability to do its job and uncover these types of safety concerns will not be tolerated. The Justice Department is committed to working with FDA to protect patients and ensure compounded drugs are safe."
The indictment further alleges that Bearden lied about Pharmakon never receiving any "out-of-specification" drug potency test results during FDA inspections in 2014 and 2016. Elmer allegedly learned of Bearden’s lies and took no action to correct Bearden or inform the FDA of its drug potency failures.
Additionally, the indictment alleges Elmer and Bearden failed to investigate the causes of the drug potency failures, failed to make changes to prevent such failures, and continued to distribute under- and over-potent drugs before receiving the potency test results.
The conspiracy charge comes with a maximum sentence of five years in prison and a $250,000 fine. The remaining charges each carry a maximum sentence of one year in prison and a $100,000 fine.
Elmer pleaded not guilty in his initial court appearance in U.S. District Court in the Southern District of Indiana and was released under specific conditions. Bearden has been issued a summons to appear before the court. The trial has been scheduled for August 21.
You can view the indictment below: