August 13, 2013: Seven Oncologists Charged with Importing Unapproved Drugs - U.S. Department of Justice Press Release
Seven Ohio oncologists were charged with importing cancer medications that had not been approved by the Food and Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.
The doctors were charged with causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act. Their names, ages and the city where they practiced medicine are:
Ranjan Bhandari, 56, Liverpool.
Timmappa Bidari, 68, Parma.
David Fishman, 62, Euclid.
Su-Chiao Kuo, 60, Brunswick.
Marwan Massouh, 54, Westlake.
Poornanand Palaparty, 62, Cleveland.
Hassan Tahsildar, 55, Euclid
"These doctors used drugs that had not been approved by the FDA," Dettelbach said. "Our office is committed to working with our partners to make sure patients are getting medicine that has been properly inspected."
"FDA's regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers," said Antoinette V. Henry, Special Agent in Charge, FDA's Office of Criminal Investigations. "We will continue to work to investigate all persons, including medical professionals, who disregard regulatory requirements and jeopardize the public health by participating in the distribution of misbranded products."
The doctors are accused of obtaining drugs, including Zometa, Kytril, Taxotere, Gemzar, Eloxatin and others, from outside the United States, where the drugs were not approved by the FDA, according to the charges.
A drug may be considered misbranded even if it is identical in composition to an FDA-approved drug (that is, a drug labeled and packaged in compliance with the FDA's standards) and even if it was made by the same manufacturer in the same facility as the FDA-approved version.
If convicted, the doctors face up to one year in prison and fines up to $100,000. Their sentences will be determined by the court after reviewing factors unique to this case, including the defendant's prior criminal record, if any, the defendant's role in the offense and the characteristics of the violation. In all cases the sentence will not exceed the statutory maximum and in most cases it will be less than the maximum.
These cases are being prosecuted by Assistant U.S. Attorney Michael L. Collyer following investigations by the FDA – Office of Criminal Investigations and the Department of Health and Human Services – Office of Inspector General.
Anyone suspecting health care fraud, waste or abuse can report it by calling the U.S. Department of Health and Human Services, Office of Inspector General at 800-447-8477. To learn more about health care fraud prevention and enforcement go to www.stopmedicarefraud.gov.
A charge is not evidence of guilt. The defendants are entitled to a fair trial in which it will be the government's burden to prove guilt beyond a reasonable doubt.