Three compounding pharmacies are accused of fraudulently selling unapproved versions of popular weight loss and diabetes drugs.
Novo Nordisk, a Danish pharmaceutical company, separately sued TruLife Pharmacy in Clay County, Brooksville Pharmaceuticals in Hernando County, and Jacksonville's WellHealth Rx in the Middle District of Florida federal court alleging that the defendants marketed and sold drugs that purport to contain semaglutide but are not FDA-approved.
“What I believe these pharmacies were doing was formulating unapproved versions of the drugs with semaglutide sodium and semaglutide acetate but what's been approved in the U.S. is actually the base form of semaglutide and there is no basis that semaglutide sodium and semaglutide acetate have any type of therapeutic effects in the body,” said Reuben Saba, vice president of medical and business affairs at Medicure, a pharmaceutical company.
Saba
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The drugs in question include Wegovy, Ozempic, and Rybelsus, which are prescription-only therapy for diabetes.
Novo Nordisk is the only company in the U.S. with FDA approval of products containing semaglutide and the FDA has yet to approve a semaglutide generic.
Ozempic alone is so popular among celebrities and social media influencers that there was a shortage, according to media reports.
IQVIA health data revealed that Ozempic prescriptions rose to more than 1.2 million from two years ago.
“One of the effects of Ozempic therapy is that, at higher amounts, it increases your sense of satiation so you feel full and once you feel full, you're not eating, and therefore that could lead to weight loss,” Saba told the Florida Record. “What I think happened here is that many patients are getting it even though they're not type two diabetic and that's taking away the supply from those patients who actually need it and potentially leading to some of these patients acquiring it through non-legitimate sources.”
The pharmacies allegedly violated the Florida Deceptive and Unfair Trade Practices Act and Novo Nordisk seeks a permanent injunction (PI) enjoining them from manufacturing and selling their versions of the drugs.
“Rather than invest the time and resources necessary to research, develop, and test its products in order to ensure that they are safe and effective and to obtain regulatory approval to market them, Defendant is simply creating, marketing, selling, and distributing Unapproved New Drugs throughout Florida and other states,” wrote Samantha J. Kavanaugh, the plaintiffs’ attorney, in the July 6 complaint in Novo Nordisk Inc. v. Brooksville Pharmaceuticals.
On July 11, U.S. District Judge William Jung ordered the appointment of a mediator Dennis M. McClelland in the Brooksville Pharmaceuticals case.
"Anytime an adverse event is reported to the FDA the pharmaceutical company has to do their due diligence to investigate that so this may involve the pharmaceutical company calling the patient and asking where they got the product," Saba added.