November 14, 2012: Indictment: Kidney Dialysis Patients Received Misbranded Drugs
Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
November 14, 2012
United States Attorney
District of Kansas
TOPEKA, KAN. - A Tennessee pharmacist is charged with substituting a cheaper drug imported from China for the iron sucrose that the Federal Drug Administration has approved for kidney dialysis patients, U.S. Attorney Barry Grissom said today.
Robert Harshbarger, Jr., 53, Kingsport, Tenn., doing business as American Inhalation Medication Specialists, Inc., is charged with one count of selling misbranded drugs, one count of mail fraud and five counts of health care fraud.
The indictment alleges that as a result of fraud by Harshbarger kidney dialysis patients treated by Kansas Dialysis Services, L.C., received iron sucrose that had not been certified by the FDA to meet quality and safety standards.
"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," said U.S. Attorney Barry Grissom. "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 there is no reason for current or former patients of Kansas Dialysis to be concerned at this time. The events outlined in the indictment ended in 2009. Any significant iron deficiencies would have been addressed during the course of a patient's dialysis treatments. Nevertheless, any questions should be addressed to a physician, Grissom said.
The indictment alleges that Harhbarger's company, American Inhalation Medication Specialists, Inc., of Kingsport, Tenn., received more than $875,000 from Kansas Dialysis and more than $845,000 from health care benefit programs including Medicare and Medicaid for misbranded iron sucrose sold from 2004 to 2009. Harshbarger misrepresented the iron sucrose drug as Venofer, which is the only iron sucrose drug approved by the FDA for both pre-dialysis and post-dialysis patients.
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.