Mayfield Doc Admits Importing Unapproved Drugs

MAYFIELD VILLAGE, OH – A Mayfield Village rheumatologist has confessed to playing fast and loose with patient safety, admitting to illegally importing medications that never received the green light from the Food and Drug Administration. Dr. David Mandel, 65, threw in the towel and pleaded guilty, facing the consequences of putting profits ahead of public health.

According to United States Attorney for the Northern District of Ohio, Steven M. Dettelbach, Mandel “admitted causing the shipment of misbranded drugs,” a misdemeanor under the Food, Drug and Cosmetic Act. This wasn’t some back-alley operation; it was a licensed medical professional deliberately circumventing federal regulations. The specific drugs in question – Boniva, Aclasta, Prolia, Euflexa and Orthovisc – were sourced from outside the U.S., where FDA approval isn’t guaranteed.

The feds are making it clear this isn’t just a paperwork issue. “FDA’s regulatory standards are designed to ensure the safety and quality of the medical devices and drugs distributed to American consumers,” stated Antoinette V. Henry, Special Agent in Charge, FDA’s Office of Criminal Investigations. “We will continue to work to investigate all persons…who jeopardize the public health by participating in the distribution of misbranded products.” Lamont Pugh III, Special Agent in Charge, U.S. Department of Health & Human Services, Office of Inspector General – Chicago Region, echoed that sentiment, emphasizing the risk to patients when medications haven’t met necessary standards.

It’s crucial to understand that even if the imported drugs *look* identical to FDA-approved versions, they’re still illegal. A drug is considered misbranded if it lacks the proper labeling and packaging mandated by the FDA, regardless of its composition or manufacturer. Mandel’s actions weren’t about access to different medications, they were about skirting the rules and potentially endangering his patients.

Now, Mandel is looking at up to one year in the slammer and a hefty fine of up to $100,000. The actual sentence will be determined by the court, taking into account his background, role in the offense, and any prior convictions. While the statutory maximum is steep, most sentences fall below that threshold. Assistant U.S. Attorney Michael L. Collyer is leading the prosecution, backed by investigations from the FDA and the Department of Health and Human Services.

If you’ve got information about healthcare fraud, waste, or abuse, don’t stay silent. Report it to the U.S. Department of Health and Human Services, Office of Inspector General at 800-447-8477. You can also find more information about fraud prevention and enforcement at www.stopmedicarefraud.gov. Remember, a guilty plea is not proof of guilt; Mandel is entitled to a fair trial where the government must prove its case beyond a reasonable doubt.