Robert Harshbarger, Jr., 53, Kingsport, Tenn., who was operating as American Inhalation Medication Specialists, Inc., pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud. He was indicted Nov. 14 in Topeka.
According to a release from the U.S. Attorney’s Office for the Eastern District of Tennessee, Harshbarger admitted that the fraud resulted in kidney dialysis patients at Kansas Dialysis Services, L.C., receiving iron sucrose that had not been certified to meet FDA quality and safety standards.
Although there were no reports patients being harmed, federal authorities said the fraud put patients at risk because the safety and effectiveness of products that are not FDA approved and come from unknown or foreign sources cannot be assured.
Harshbarger admitted that health insurers paid more than $848,000 for the misbranded drugs, which he distributed between 2004 and 2009.
Federal authorities said the Kingsport pharmacist misrepresented the iron sucrose drug as Venofer, which is the only form of iron sucrose approved by the FDA for both pre-dialysis and post-dialysis patients.
The iron sucrose used was purchased from several Chinese companies, including Qingdao Shenbang Chemical Company in Qingdao, China, and Shanghai Rory Fine Chemicals Co., Ltd., in Shanghai, China.
Authorities said iron sucrose Harshbarger purchased from China was cheaper than the name-brand Venofer.
Harshbarger is scheduled to be sentenced Nov. 4. under a plea agreement that recommends a sentence of 48 months in federal prison, plus restitution of approximately $848,504, a criminal fine of $25,000, and a forfeiture judgment of $425,000. The restitution and fines must be paid prior to sentencing.