Tennessee Pharmacist Sentenced to 4 Years in Misbranded Dialysis Drug Case
Suspect iron sucrose is available in metric tons on the Internet from Chinese chemical companies.
Robert Harshbarger, Jr., a Tennessee pharmacist who recently pled guilty to supplying dialysis clinics with non-FDA approved, Chinese-made dialysis treatments has been sentenced to 4 years in prison for his crimes.
According to the DOJ at the time of his guilty plea, Harshbarger pleaded guilty on May 21 to charges he replaced FDA-approved iron sucrose for use in kidney dialysis with unapproved foreign versions of the drug in sales to several kidney dialysis clinics, including Kansas Dialysis Services. He “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,” reports the FDA. He purchased the non-FDA approved drugs from several Chinese companies including Qingdao Shenbang Chemical Company in Qingdao, China, and Shanghai Rory Fine Chemicals Co., Ltd., in Shanghai, China.
Harshbarger was doing business as American Inhalation Medication Specialists, Inc. He pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud. In his plea, he admitted that kidney dialysis patients treated by Kansas Dialysis Services, L.C., received misbranded Chinese iron sucrose instead of iron sucrose that had been certified by the FDA to meet quality and safety standards, reports the FDA.
In addition to spending 4 years in prison, Harshbarger has been required to pay restitution of $848,504 and a $25,000 criminal fine, in addition to forfeiting $425,000 in cash, reports the FDA.