BY ROY ALBERT ANDRADE, K1LLER, Inc.
NOBLESVILLE, INDIANA - On June 22, 2017, Paul J. Elmer, 64, and Caprice R. Bearden, 62, of Pharmakon Pharmaceuticals, Inc. were charged in a 10-count indictment, including defrauding the United States and distributing adulterated drugs. Elmer was the owner of Pharmakon, and Bearden was the Director of Compliance of Pharmakon. Pharmakon Pharmaceuticals, Inc. was a licensed Food and Drug Administration (FDA) registered, and DEA licensed manufacturer, that faild to provide precise sterile admixing services that adhered to every United States Pharmacopeial Convention <797> and Current Good Manufacturing Practices requirements. Elmer and Bearden failed to notify customers and the FDA of potency failures.
On March 6, 2014, Bearden falsified information to FDA investigators, claiming she did not obtain potency results, even though they did in fact receive numerous notices of out-of-specification test results. In March 2014, a hospital employee was preparing to administer a dosage of midazolam, a drug used for procedural sedation, and acknowledged two conflicting strengths on the labeling of a syringe provided by Pharmakon Pharmaceuticals, Inc.. The health professional filed a voluntary report with MedWatch from the hospital, and sparked an onsite investigation conducted by the FDA Office of Criminal Investigations. In conclusion, Pharmakon failed to respect FDA regulations by compounding, and distributing their drugs that were either under-or-over-potent.
On November 22, 2017, The 62-year-old Director of Compliance of Pharmakon pleaded guilty to three misdemeanor counts of introducing adulterated drugs, as described in the FD&C Act under Section 501, into interstate commerce, and six misdemeanor counts among other criminal offenses in the Southern District of Indiana. Chief U.S. District Judge Jane E. Magnus-Stinson, sworn in as a Judge of the United States District Court for the Southern District of Indiana on June 14, 2010, accepted Bearden’s plea. A day for sentencing has not been established as of this writing.
"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.”
Shawn W. Anderson
Jessica K. Mattingly
Roy Albert Andrade