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A former compliance director for the now-shuttered pharmacy compounder Pharmakon Pharmaceuticals Inc. pleaded guilty to distributing subpotent and overpotent compounded drug products to hospitals around the country.
Caprice R. Bearden, of Carmel, Ind., pleaded guilty in the U.S. Court for the Southern District of Indiana, including to a charge she knowingly conspired to defraud the FDA by obstructing its lawful functions, the Justice Department said Nov. 22. She also pleaded guilty to introducing adulterated drugs into interstate commerce, including opioids nearly 25 times the strength indicated on the labels of the drugs being administered to three infants ( United States v. Elmer, S.D. Ind., No. 17-cr-0113-JMS-TAB, guilty plea announced 11/22/17 ).
Bearden’s guilty plea comes as the FDA is stepping up its enforcement efforts in the pharmacy compounding area. So far this year, the agency has sent more than 30 warning letters to pharmacy compounders about their noncompliance with current good manufacturing (cGMP) practice requirements. During 2016, the agency sent more than 40 warning letters to compounders.
The Drug Quality and Security Act of 2013 gave the FDA more power to oversee these pharmacies. The act was passed in response to a 2012 fungal meningitis outbreak associated with injectable drugs produced by a compounding facility.
In drug compounding, a licensed pharmacist combines, mixes, or alters ingredients of a drug to create a medication for an individual patient. Patients in several states received overpotent drugs compounded by Pharmakon, which led to a national recall and the closure of the facility.
A Food and Drug Administration investigation precipitated the closing of the 200-employee Pharmakon compounding facility in Noblesville, Ind., in the fall of 2016.
Starting in July 2013, Bearden knew some of the pharmacy’s drugs were being compounded with the improper strength but didn’t disclose this to customers or to the agency. Bearden lied to the FDA, telling the agency she wasn’t aware of any failed potency tests. As part of her plea agreement, she admitted to lying to the agency about the drug potency test results.
“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,” FDA Commissioner Scott Gottlieb said in a Nov. 22 statement. “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 FDA warned the facility about problems in two warning letters, one issued in September and another in 2015. The most recent warning letter said Pharmakon’s sterile drug products were prepared, packed, or held under unsanitary conditions and may have become contaminated.
For example, the FDA told Pharmakon that its investigators observed that materials and components weren’t disinfected before use. In 2015, the FDA found several current good manufacturing practice (cGMP) violations at Pharmakon, including technicians touching nonsterile surfaces with gloved hands and then performing aseptic manipulations without first re-disinfecting the gloves.
The conspiracy charge to which Bearden pleaded guilty carries a 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 Justice Department said. The six 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.
Chief Judge Jane E. Magnus-Stinson accepted the plea but hasn’t yet scheduled a sentencing date.
The FDA Office of Criminal Investigations 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.
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