Inspections, Compliance, Enforcement, and Criminal Investigations

August 18, 2014: Mayfield Village Doctor Forfeits $650,000 After Importing Misbranded Drugs

OCI Small Clear Seal
 

Food and Drug Administration
Office of Criminal Investigations

U.S. Department of Justice Press Release

 

For Immediate Release
August 18, 2014

United States Attorney
Northern District of Ohio

 

A Mayfield Village rheumatologist was sentenced to probation for importing medications that had not been approved by the Federal Drug Administration, said Steven M. Dettelbach, United States Attorney for the Northern District of Ohio.

Dr. David Mandel, 65, has paid more than $650,000 in restitution. He previously pleaded guilty to causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act.

"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, Washington Field Office. "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."

"Acquiring and prescribing prescription medications that have not met regulatory standards puts the safety and well-being of patients at risk," said Lamont Pugh III, Special Agent in Charge, U.S. Department of Health & Human Services, Office of Inspector General -Chicago Region. "The OIG will continue to work with our law enforcement partners to ensure that medical professionals who choose to evade these standards are held accountable."

Dr. Mandel obtained Boniva, Aclasta, Prolia, Euflexa and Orthovisc, from outside the United States, where the drugs are not approved by the FDA, according to court documents.

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.

The case was 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 healthcare fraud prevention and enforcement go to www.stopmedicarefraud.gov

Page Last Updated: 01/28/2015
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