TOPEKA, Kan. (WBW) - A Tennessee man is accused of substituting a cheaper, unapproved drug from China in medications it sold to Kansas Dialysis.
The U.S. Attorney's Office announced an indictment Wednesday against 53-year-old Robert Harshbarger, Jr. of Kingsport, Tenn. for one count of selling misbranded drugs, one count of mail fraud and five counts of health care fraud. Harshbarger did business as American Inhalation Medication Specialists, Inc.
The indictment alleges Harshbarger substituted the cheaper drug for the iron sucrose drug Venofer received by kidney dialysis patients treated by Kansas Dialysis Services, L.C. The substance was not certified by the Food and Drug Administration to meet quality and safety standards.
According to the indictment, Harhbarger’s company sold the misbranded substance from 2004 to 2009. It received more than $875,000 from Kansas Dialysis and more than $845,000 from health care benefit programs including Medicare and Medicaid for the misbranded drug.
“Although there are no reports of patient harm associated with the drugs that are alleged to be misbranded in this indictment, patient health was put at risk,” U.S. Attorney Barry Grissom said in a statement. “The FDA cannot assure the safety and effectiveness of products that are not FDA approved and come from unknown sources and foreign locations, or that may not have been manufactured under proper conditions. These unknowns put patients’ health at risk because of uncertainty concerning the product’s content, purity and source.”
Grissom said current and former patients of Kansas Dialysis do not need to be concerned. He says iron deficiencies would have been addressed during the course of a patient’s dialysis treatments.
Grissom did say patients should bring any questions to their physicians.
According to the U.S. Attorney's office, Harshbarger purchased iron sucrose from Chinese companies including Qingdao Shenbang Chemical Company in Qingdao, China, and Shanghai Rory Fine Chemicals Co., Ltd., in Shanghai, China. The iron sucrose from China was cheaper than purchasing Venofer.
If convicted, Harshbarger faces a maximum penalty of 20 years in federal prison and a fine up to $250,000 on the mail fraud count; a maximum penalty of 10 years and a fine up to $250,000 on each of the health care fraud counts; and a maximum penalty of three years and a fine up to $250,000 on the charge of selling a misbranded drug.
The Food and Drug Administration and the Dept. of Health and Human Services, Office of Inspector General, investigated. Assistant U.S. Attorney Tanya Treadway is prosecuting.