The former compliance director of an Indiana compounding pharmacy pleaded guilty to introducing adulterated drugs into interstate commerce and conspiracy to defraud the United States by obstructing the Food and Drug Administration's (FDA) lawful functions, the Department of Justice announced.
Caprice R. Bearden, 63, of Carmel, Indiana, pleaded guilty in the Southern District of Indiana to one count of conspiracy to defraud the United States, three misdemeanor counts of introducing an adulterated drug in interstate commerce, and six misdemeanor counts of adulterating drugs while held for sale after shipment of a drug component in interstate commerce. Bearden was the Director of Compliance for Pharmakon Pharmaceuticals Inc. (Pharmakon). Pharmakon compounded drugs at a facility in Noblesville, Indiana, for customers in various states.
Chief U.S. District Judge Jane E. Magnus-Stinson accepted Bearden's plea. A date for sentencing has not been sent yet.
"This guilty plea demonstrates the Justice Department's commitment to protecting patients and ensuring that compounded drugs are safe," said Principal Deputy Assistant Attorney General Chad A. Readler of the Justice Department's Civil Division. "Distributing out-of-specification drug products poses a serious risk of harm to patients. The Justice Department will not tolerate efforts to impede FDA's ability to uncover these types of safety concerns."
"This defendant distributed serious drugs to hospitals in Indiana and around the country, knowing that the drugs were significantly under or over the strength they were supposed to be," said Josh Minkler, United States Attorney for the Southern District of Indiana. "She put greed and the reputation of her company ahead of the health and safety of our most vulnerable patient populations."
As part of her plea agreement, Bearden acknowledged that during 2014 and 2016 FDA inspections, she lied about Pharmakon's never having received any out-of-specification drug potency test results. Bearden also acknowledged that she knowingly conspired with another individual to defraud the United States by obstructing the lawful functions of the FDA. In addition, she acknowledged that it was the purpose of the conspiracy to prevent the loss of revenue that would result from customers' and FDA's knowledge of Pharmakon's having distributed numerous compounded drugs that were not the strength purported on the drugs' labeling.
"This is an egregious example of how harmful conduct can result in risk to patients. The disregard for the law resulted in the injury of infants from poorly compounded, super potent morphine products," said FDA Commissioner Scott Gottlieb, M.D. "We will not tolerate substandard practices, like failing to meet federal manufacturing standards like those found at Pharmakon, that put patients at risk and will aggressively pursue individuals that put profit ahead of patient safety."
The conspiracy charge to which Bearden pleaded guilty carries a statutory maximum sentence of five years in prison and a fine of $250,000 or twice the gross gain or gross loss from the offense. The misdemeanor charges of distributing an adulterated drug in interstate commerce and adulterating drugs while held for sale after shipment of a drug component in interstate commerce each carry a statutory maximum punishment of one year in prison and a fine of $100,000 or twice the gross gain or gross loss from the offense.
Principal Deputy Assistant Attorney General Readler and U.S. Attorney Minkler commended the FDA Office of Criminal Investigations, which conducted the investigation. Trial Attorney David A. Frank of the Civil Division's Consumer Protection Branch and Assistant U.S. Attorney Cindy J. Cho, of the U.S. Attorney's Office for the Southern District of Indiana, are prosecuting the case.