An Ashland physician, Matthew Lewis, 44, admitted to his involvement in the distribution of misbranded semaglutide, entering a guilty plea before Chief U.S. District Judge David L. Bunning. Lewis, who owns Lewis Family Care, faced charges for receiving a misbranded drug and offering it for sale with the intent to defraud or mislead.
The U.S. Food and Drug Administration (FDA) has approved semaglutide for certain medications, specifically Ozempic, Rybelsus, and Wegovy. These drugs are intended to improve blood sugar levels in adults with diabetes or, in the case of Wegovy, for weight loss. However, no generic versions of semaglutide are FDA-approved. In his plea, Lewis admitted to purchasing non-FDA approved semaglutide from suppliers in California and Georgia for use in a weight loss clinic, beginning in May 2023. These suppliers were not FDA-registered as drug manufacturers or outsourcing facilities, nor were they licensed pharmacies or prescription drug wholesalers.
The non-approved semaglutide often arrived at his clinic labeled for lab research only, lacking directions, warnings, expiration dates, and ingredient lists. Lewis reportedly disguised the source of these drugs, ordering them through unconventional methods and masking transactions. He did not inform patients that the administered semaglutide was not FDA-approved. His clinic earned $249,044.40 from this practice from May 2023 to February 2024.
"Prescription drugs are highly regulated in this country in order to keep patients safe," said Acting U.S. Attorney Paul McCaffrey. He continued, "At a time of increased public interest in weight-loss drugs like Wegovy, Lewis chose profit margins over patient safety."
George Scavdis, Special Agent in Charge, FDA Office of Criminal Investigations, commented, "Physicians who administer misbranded drugs...not only puts their patients’ health at risk but also violate their patients’ trust.”
Lewis is due for sentencing on August 18, facing up to three years in prison. The investigation was led by the FDA-OCI, with Assistant U.S. Attorney Brittany Dunn-Pirio prosecuting the case.
