A pharmacist in Tennessee named Robert Harshbarger has pleaded guilty to charges he replaced FDA-approved iron sucrose for use in kidney dialysis with unapproved foreign versions of the drug which he then sold to kidney dialysis clinics, including Kansas Dialysis Services. Several patients at Kidney Dialysis Services were treated with the misbranded drugs, but none reported side effects. The iron sucrose was purchased by Harshbarger from several Chinese companies. None of it had been tested or approved by the FDA.
Who: Food and Drug Administration Office of Criminal Investigations (FDA_OCI), Department of Health and Human Services – Office of Inspector General., U.S. Department of Justice.
When: May 21, 2013, 2004-2009.
Where:Kingsport, Tennessee, U.S.A.
How: Investigation by The U.S. Food and Drug Administration Office of Criminal Investigation.
Additional details: Harshbarger’s plea agreement recommends 4 years 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.
“ Pharmacist’s Plea: Kidney Dialysis Patients Received Misbranded Drugs,” U.S. Department of Justice Press Release. May 21, 2013.
“ Kingsport pharmacist pleads guilty in misbranded drug case,” Times News. May 22, 2013.
“ Kidney dialysis patients received misbranded drugs,”Kansas First News. August May 21, 2013.
“ Indictment: Kidney Dialysis Patients Received Misbranded Drugs,” U.S. Department of Justice Press Release. November 14, 2012.