A Kansas-based dialysis service put its patients at risk when it accepted a cheaper, misbranded iron sucrose substitute from a Tennessee-based pharmacist.
Robert Harshbarger Jr., 53, pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud. The pharmacist was doing business as American Inhalation Medication Specialists, Inc.
The crime occurred from 2004 to 2009, with Harshbarger purchasing iron sucrose from Chinese companies including Qingdao Shenbang Chemical Company in Qingdao, China, and Shanghai Rory Fine Chemicals Co., Ltd., in Shanghai, China. The cheaper Chinese iron sucrose was misrepresented as Venofer, which is the only FDA-approved iron sucrose for both pre-dialysis and post-dialysis patients.
Harshbarger admitted that health care benefit programs paid more than $848,000 for the misbranded iron sucrose.
No patients were reported to have been harmed by the misbranded drug, but the FDA cannot assure the safety and effectiveness of products from unknown sources or foreign locations.
Harshbarger’s plea agreement includes a recommended sentence of 48 months in federal prison, restitution of approximately $848,504, a criminal fine of $25,000, and a forfeiture judgment of $425,000 to be paid prior to sentencing. Sentencing is set for November 4.
U.S. Attorney Barry Grissom commended the Food and Drug Administration, the Dept. of Health and Human Services, Office of Inspector General, and Assistant U.S. Attorney Tanya Treadway for their work on the case.
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Key Facts
- State: Kansas
- Category: Drug Trafficking|White Collar Crime
- Source: DOJ Press Release â†â€â€
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