ASHLAND, KY – An Ashland physician and owner of Lewis Family Care, Matthew Lewis, 44, pleaded guilty on Monday, before Chief U.S. District Judge David L. Bunning to receiving a misbranded drug and offering it for sale with the intent to defraud or mislead.
According to the charges against Lewis, the United States Food and Drug Administration (FDA) has approved three drugs with semaglutide as the active ingredient – Ozempic, Rybelsus, and Wegovy – to improve blood sugar levels in adult patients with diabetes or, in the case of Wegovy, for weight loss. The FDA did not approve any generic semaglutide drugs. In his plea agreement, Lewis admitted that beginning in May 2023, he purchased non-FDA approved semaglutide from suppliers in California and Georgia to administer to patients at a weight loss clinic. These companies were not registered with the FDA as drug manufacturers or outsourcing facilities of compounded drugs, were not authorized to distribute semaglutide, and were not licensed pharmacies or licensed prescription drug wholesalers. Lewis obtained the semaglutide from these unauthorized suppliers at a significantly lower cost than the legitimate prescription drugs.
This non-FDA approved semaglutide sometimes arrived at Lewis Family Care packaged in a vial that contained a warning that the drugs were intended for lab research and development only. The labels failed to provide adequate directions for use, adequate warnings, failed to contain an expiration date, and failed to list its active and inactive ingredients. Lewis took measures to disguise and mislead others as to the unauthorized sources of the semaglutide. For example, he purchased the semaglutide using Venmo, Afterpay, or via phone, and he described the orders on his Venmo payments as “Meal Prep.” Lewis stored the drugs in his office, separate from Lewis Family Care’s other legally obtained medications. He did not inform his patients that he was administering non-FDA approved semaglutide to them. Between May 2023 and February 2024, Lewis Family Care’s weight loss clinic earned $249,044.40 from the administration of this unapproved semaglutide.
“Prescription drugs are highly regulated in this country in order to keep patients safe,” said Acting U.S. Attorney Paul McCaffrey. “At a time of increased public interest in weight-loss drugs like Wegovy, Lewis chose profit margins over patient safety when he purchased non-FDA approved semaglutide and administered it to his patients.”
“Physicians who administer misbranded drugs that come from outside the secure and regulated supply chain—particularly products that are injectable and pose sterility concerns—not only puts their patients’ health at risk but also violate their patients’ trust,” said George Scavdis, Special Agent in Charge, FDA Office of Criminal Investigations, Metro Washington Field Office. “We will continue to pursue and bring to justice those who would disregard and jeopardize public health and safety by selling misbranded drugs.”
Acting U.S. Attorney McCaffrey and FDA Special Agent in Charge Scavdis, jointly announced the guilty plea.
The investigation was conducted by the FDA-OCI. Assistant U.S. Attorney Brittany Dunn-Pirio is prosecuting the case on behalf of the United States.
Lewis is scheduled to be sentenced on August 18. He faces a maximum of three years in prison and any applicable restitution. However, any sentence will be imposed by the Court, after its consideration of the U.S. Sentencing Guidelines and the federal sentencing statutes.
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