An Ashland-based physician, Matthew Lewis, has entered a guilty plea in a case involving the distribution of misbranded semaglutide, the active ingredient in FDA-approved drugs Ozempic, Rybelsus, and Wegovy. This announcement was made in court before Chief U.S. District Judge David L. Bunning.
Lewis, aged 44, admitted to purchasing non-FDA approved semaglutide from suppliers in California and Georgia from May 2023. These suppliers were not recognized by the FDA as drug manufacturers or authorized distributors, and Lewis procured the semaglutide at a reduced cost compared to approved versions. In some cases, the drugs arrived labeled for research use only, missing crucial information such as directions for use, warnings, expiration dates, and ingredient details.
The U.S. Food and Drug Administration emphasizes that semaglutide is only approved in the FDA-sanctioned drugs specifically identified for diabetes management or weight loss. However, Lewis administered the unapproved version within his weight-loss clinic. To conceal the sources of these drugs, he engaged payment platforms like Venmo, where transactions were deceptively labeled, for example as “Meal Prep.” Additionally, he did not inform his patients about the unapproved status of the drugs administered to them.
The clinic reportedly earned $249,044.40 from these treatments between May 2023 and February 2024. Acting U.S. Attorney Paul McCaffrey critiqued Lewis for "choosing profit margins over patient safety." Meanwhile, George Scavdis from the FDA Office of Criminal Investigations commented on the breach of trust and risk to patient health through the use of misbranded drugs.
The joint announcement of the plea was made by McCaffrey and Scavdis. The investigation was carried out by the FDA's Office of Criminal Investigations. Prosecutor Brittany Dunn-Pirio is handling the case for the United States.
Lewis is set to be sentenced on August 18, facing up to three years in prison and possible restitution. The exact sentence will be determined by the Court in light of the U.S. Sentencing Guidelines and relevant federal statutes.