An Ashland physician and owner of Lewis Family Care, Matthew Lewis, 44, pleaded guilty 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.