Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
April 29, 2014
United States Attorney
Northern District of Ohio
Contact: AUSA Michael L. Collyer
A Mayfield Village rheumatologist pleaded guilty to 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, admitted causing the shipment of misbranded drugs, a misdemeanor violation of the Food, Drug and Cosmetic Act.
"This doctor 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." "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 â€“ 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 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.
Dr. Mandel faces up to one year in prison and fines up to $100,000. His sentence will be determined by the court after reviewing factors unique to this case, including his prior criminal record, if any, his 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 â€“ Office of Criminal Investigations and the Department of Health and Human Services â€“ 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.