The former compliance director of an Indiana compounding pharmacy pleaded guilty Wednesday to introducing adulterated drugs into interstate commerce and then covering up the offenses by obstructing the Food and Drug Administration.
Caprice R. Bearden, 63, of Carmel, Indiana, pleaded guilty in federal court in Indiana to one count of conspiracy to defraud the United States, three misdemeanor counts of introducing an adulterated drug into interstate commerce, and six misdemeanor counts of adulterating drugs.
Bearden was the Director of Compliance for Pharmakon Pharmaceuticals Inc. Pharmakon compounded drugs at a facility in Noblesville, Indiana.
A date for sentencing hasn’t been sent.
Bearden faces up to five years in prison on the conspiracy charge, and a fine of $250,000. The misdemeanor counts can each be punished by up to one year in prison and a fine of $100,000.
The drugs were distributed to hospitals in Indiana and around the country. The DOJ said Bearden knew some of the drugs were “significantly under or over the strength they were supposed to be.”
Paul J. Elmer, president and owner of Pharmakon, also faces federal charges of engaging in commerce with adulterated drugs. He and Bearden were indicted in June this year.
One painkiller compounded by Pharmakon was 25 times stronger than its label said. At least 14 babies were given the painkiller and three became sick, the DOJ said. No infants died after taking the mislabeled drugs.
Pharmakon knew about the compounding errors but didn’t notify the FDA or health care providers and lied to FDA investigators during a 2014 inspection.
During that inspection, the indictment said, Bearden said Pharmakon had never received test results outside of the targeted potency range. In fact from 2013 to 2016, Bearden was notified of about 70 test results showing that Pharmakon drugs were either stronger or weaker than labeled, the DOJ said.
Josh Minkler, U.S. Attorney for the Southern District of Indiana said Bearden “put greed and the reputation of her company ahead of the health and safety of our most vulnerable patient populations.”
FDA Commissioner Scott Gottlieb said, “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.”
Richard L. Cassin is the publisher and editor of the FCPA Blog.