Ex-Pharmacy Compliance Director pleads guilty to introducing illegal drugs into the market

Caprice Bearden, a 63-year old ex-Director of Compliance for an Indiana-based Pharmakon, has been found guilty of introducing adulterated drugs into the market and obstructing the US FDA’s lawful functions, the Department of Justice has announced.

Bearden plead guilty to one count of fraudulent conspiracy, three counts of misdemeanour for introducing an adulterated drug to interstate commerce, and six counts of misdemeanour for adulterating drugs while they were being held for sale. The conspiracy charge alone means that Bearden faces a five-year jail sentence and a $250,000 fine, while the misdemeanour charges carry a fine of $100,000 and one year in prison.

"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 Southern District of Indiana US Attorney Josh Minkler. "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 she wilfully lied to FDA inspectors about never having received out-of-specification drug potency test results between 2014 and 2016. She also admitted to conspiring with another individual in order to avoid revenue loss that would have resulted through knowledge that Pharmakon had distributed compounded drugs whose strength was not accurately represented on their labels.

"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," added Principal Deputy Assistant Attorney General Chad A Readler.

FDA Commissioner Scott Gottlieb also commented on the announcement, saying: "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."