The Food and Drug Administration is currently conducting an investigation into multiple fraudulent schemes involving counterfeit versions of Ozempic, according to a recent warning issued by an industry trade group.
The warning highlights the surge in demand for Ozempic and similar drugs for weight loss, following the discovery of a counterfeit Ozempic injector pen at a U.S. pharmacy earlier this year.
An alert sent to members of the Pharmaceutical Cargo Security Coalition by the FDA reveals that fraudsters are posing as employees of legitimate medical wholesalers and taking over their accounts.
These fraudsters then target unsuspecting pharmacies seeking discounted drugs, taking advantage of the nationwide shortage of certain formulations.
The alert warns that the scammers provide enough information and documentation to make their transactions appear legitimate, often requiring upfront payment via wire transfer and involving fraudulent transaction statements.
Origin of Ozempic Counterfeits
The investigation reveals that some victims have received counterfeit Ozempic pens or diverted versions from other countries. Counterfeit imports of semaglutide-based products, including Ozempic and Wegovy, have been identified in various locations around the world.
While the alert does not specify whether the counterfeits are being smuggled into the U.S. or produced domestically, it does mention that the illicit activity has been observed at both the distributor and pharmacy levels.
CBS News reached out to the Healthcare Distribution Alliance, who confirmed that the alert was shared with its members. Further inquiries regarding the investigation were referred to the FDA.
An FDA spokesperson stated that they did not have specific details to share about counterfeit reports at the moment.
Cautionary Note on Fakes and Side Effects
The fraud alert sheds light on how a counterfeit Ozempic pen ended up being filled as a prescription at a legitimate pharmacy earlier this year. This development follows Novo Nordisk’s previous warning in June about a counterfeit version linked to an adverse reaction.
Photos released by Novo Nordisk showed the similarities and errors between the counterfeit and authentic products. The counterfeit pen contained a different diabetes medication, insulin glargine injection, and displayed a typo and poor label quality.
The number of additional counterfeits reported to Novo Nordisk following the June warning, as well as cases of unsuspecting pharmacies filling prescriptions with knockoffs, remain unclear.
A spokesperson for Novo Nordisk declined to provide further information regarding the reported counterfeits but assured that they are working closely with the FDA to raise awareness and identify potential counterfeit products.
Investigating Illegal Sales of Semaglutide
The alert also reveals that the FDA has been investigating illegal online sales of semaglutide, as well as tirzepatide, another diabetes drug used for weight loss.
While some pharmacies are allowed to prepare compounded versions of drugs during shortages, the FDA has expressed concerns over knockoff versions using incorrect versions of semaglutide compared to Wegovy and Ozempic.
Novo Nordisk has taken legal action against medical spas and compounding pharmacies for marketing compounded semaglutide. The company claims that these practices create confusion, deception, and potential safety concerns.
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