A Tennessee pharmacist just pleaded guilty to swapping a cheaper drug substitute for the U.S. Food and Drug Administration (FDA) approved iron sucrose drug for kidney dialysis patients.
The pharmacist, Robert Harshbarger, 53, substituted a cheaper version of the drug from China, which was administered to kidney dialysis patients in Kansas, according to Kansas First News. Harshbarger was conducting business as American Inhalation Medication Specialists, Inc. and pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud.
In his plea, Harshbargner admitted that, because of the fraud, kidney dialysis patients who were treated by Kansas Dialysis Services, L.C. received iron sucrose that was not FDA-approved to meet quality and safety standards, according to Kansas First News. The information was part of a release from the U.S. Attorney’s Office for the Eastern District of Tennessee, according to The Times News.
No reports of patient harm have been received; however, the criminal activity put patients at risk as the FDA is unable to assure safety and efficacy for products that have not gone through the FDA approval process and which come from unknown sources or foreign locations, Kansas First News indicated.
Harshbarger also admitted that health care benefit programs paid in excess of $848,000 for the misbranded iron sucrose he distributed in 2004 – 2009. The iron sucrose was sold as Venofer, the only FDA-approved iron sucrose drug for pre- and post-dialysis patients, Kansas First News reported.
The pharmacist purchased the unapproved iron sucrose from Chinese companies including Qingdao Shenbang Chemical Company in Qingdao, China and Shanghai Rory Fine Chemicals Co., Ltd., in Shanghai, China, according to Kansas First News. The counterfeit iron sucrose secured from China was less expensive than purchasing the FDA-approved Venofer.
Both parties have agreed to the sentencing recommendation of 48 months in federal prison, restitution of about $848,504, a $25,000 criminal fine, and a $425,000 forfeiture judgment to be paid before sentencing, which is scheduled for November 4th, according to Kansas First News. The FDA, the Department of Health and Human Services, the Office of Inspector General, and Assistant U.S. Attorney Tanya Treadway collaborated on the case.
Harshbarger, Jr., was indicted on November 14 in Topeka, Kansas, according to The Times News.