WASHINGTON — The Food and Drug Administration is now investigating an array of fraudulent schemes that appear to be trafficking counterfeit versions of Ozempic, an industry trade group recently warned its members.
The new warning about knockoffs of Ozempic and similar drugs, which have seen demand surge over their use for weight loss, comes after a counterfeit Ozempic injector pen was discovered being sold at a U.S. pharmacy earlier this year.
FDA investigators have found that fraudsters are passing themselves off as employees of medical wholesalers, effectively taking over accounts of the legitimate licensed companies, according to an alert sent to supply chain industry members of the Pharmaceutical Cargo Security Coalition obtained by CBS News.
They then target unsuspecting pharmacies looking for discounts on the drug, the alert says. Some formulations remain in short supply nationwide as demand for the medications has grown.
"The sellers offer sufficient information and documentation to give the appearance the transaction is legitimate," the alert warns. "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."
There are Ozempic counterfeits coming from?
Some of the victims have received counterfeit Ozempic pens or versions diverted from other countries, the alert says investigators have found. Others get none at all.
Warnings of counterfeit imports of products that use semaglutide — which include Ozempic and Wegovy — have also turned up around the world. Health authorities from Nigeria to Australia have announced finding illegal imports of counterfeits.
While some of the scams being investigated have involved Ozempic diverted from overseas, it is unclear from the alert whether the counterfeits are also being smuggled into the country or are being produced by scammers within the U.S.
"This illicit activity has been detected at both the distributor and pharmacy levels," the alert says.
A spokesperson for the Healthcare Distribution Alliance confirmed to CBS News that the alert had been shared with members of its coalition, but referred further questions about the investigations to the FDA.
An FDA spokesperson said they did not have details to share about counterfeit reports.
A waning about fakes and side effects
The fraud alert sheds new light on how a knockoff Ozempic pen may have wound up being filled as a prescription at a legitimate pharmacy earlier this year.
News of the FDA's growing investigations comes after Novo Nordisk's warning in June that a counterfeit version had turned up in the U.S. linked to a report of someone who had suffered an adverse reaction following use of the product.
Photos released by the company show how the counterfeit pen and carton tried to closely imitate the authentic product. However, the company said it had some errors, like a typo on the box and a poor quality label.
"The counterfeit product appears to have contained another type of diabetes medication, insulin glargine injection, that works differently than Ozempic," the company had said.
It is unclear how many additional counterfeits have been reported to the drugmaker from American pharmacies in the wake of the June warning, or if other unsuspecting pharmacies have filled prescriptions for Ozempic with knockoffs they thought were legitimate.
A spokesperson for Novo Nordisk did not answer questions about how many other counterfeits have been reported.
In a statement, the company said they were working "in close collaboration" with the FDA to raise awareness around the risk for counterfeits of their products.
"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," Novo Nordisk said.
Investigating illegal sales of semaglutide
Separately, the alert also says that the FDA has also been investigating illegal sales of semaglutide online as well as tirzepatide, another diabetes drug branded as Mounjaro by Eli Lilly which has been used for weight loss.
While the FDA says some pharmacies are allowed to prepare "compounded" versions of drugs while they are listed in shortage by the agency, the FDA has also previously voiced concern over firms selling knockoffs that were using the wrong versions of semaglutide compared to what is used in Wegovy and Ozempic.
Novo Nordisk has also sued some medical spas and compounding pharmacies that they accused of overstepping their boundaries in marketing compounded versions of semaglutide.
"These unlawful marketing and sales practices, including the use of Novo Nordisk trademarks in connection with these practices, have created a high risk of consumer confusion and deception as well as potential safety concerns," the company said in a June news release.
