The FDA has started investigating schemes to sell counterfeit versions of Ozempic to unsuspecting pharmacies, according to an Oct. 4 industry alert obtained by CBS News.
Federal regulators are probing cases where schemers pose as legitimate wholesalers, offering to sell Ozempic with large discounts to unsuspecting pharmacies, according to an alert sent to supply chain industry members of the Pharmaceutical Cargo Security Coalition.
"The sellers offer sufficient information and documentation to give the appearance the transaction is legitimate," the alert says. "The transaction requires full or partial payment upfront via wire transfer, non-disclosure agreements, establishment of purchase accounts, and on occasions, have involved fraudulent transaction statements."
In some cases, purchasers have received Ozempic products "diverted from foreign countries or counterfeit," according to the alert. In other cases, the purchaser never receives the order. The warning doesn't make clear whether scammers are producing fake Ozempic pens in the U.S. The alert also says the FDA is investigating online sales of semaglutide, the active ingredient in Ozempic, and tirzepatide, the active ingredient in Eli Lilly's diabetes drug Mounjaro. Most of those products are sold in the form of injectable vials labeled as semaglutide and are counterfeit.
An FDA spokesperson told CBS they did not have any details to share on the matter. A spokesperson for Novo Nordisk, the manufacturer of Ozempic, shared the following statement with the news outlet, though there was no comment on how many counterfeit reports the drugmaker has received from U.S. pharmacies:
"We have provided communications to a number of stakeholders, including wholesalers and pharmacists to ensure they are aware of the situation and also able to identify a potential counterfeit semaglutide injectable product."
In June, Novo Nordisk filed lawsuits against three compounding pharmacies, accusing them of illegally compounding forms of the drug. It has also sued six medical spas and clinics for similar allegations.