Novo Nordisk files 11 more compounding lawsuits across seven states

Novo Nordisk filed 11 new lawsuits in August 2024 against medical spas, weight-loss clinics and telehealth companies that advertised compounded versions of its semaglutide products, according to Endpoints News reporting cited by industry outlets ^[1]. The suits were filed across seven states: California, Florida, Michigan, New Jersey, Oklahoma, Pennsylvania and Washington ^[1]. That brings Novo's total legal actions against compounders to 34, with six resulting in permanent injunctions ^[1].

The legal push comes as both major GLP-1 makers report finding serious problems with compounded copies of their drugs. Eli Lilly's chief scientific and medical officer, Dan Skovronsky, told investors on an August 8, 2024 earnings call that when the company obtained samples from compounding labs and tested them, "in most instances, this isn't [our] kind of tirzepatide at all" ^[1]. He said compounders were often selling entirely different chemicals, or products full of impurities and sometimes contaminated with bacteria ^[1]. In at least one case, Lilly found a product that was nothing more than sugar alcohol ^[1].

The scale of the safety concern is documented by federal regulators. The FDA told the Washington Post that between August 2021 and mid-July 2024, it reviewed 288 reports of adverse reactions tied to compounded semaglutide and 108 reports tied to compounded tirzepatide, with some patients requiring hospitalization ^[1]. Since late 2023, the FDA has issued 10 warning letters over misbranded, adulterated or illegal sales of semaglutide and tirzepatide, targeting companies including US Chem Labs, Synthetix Inc. (doing business as Helix Chemical Supply), and AnuMed International, as well as websites like gorillahealing, semaspace, Ozempen and dashpct ^[1]. None of these operations were registered as 503B outsourcing facilities, the FDA-regulated category that must follow stricter manufacturing standards ^[1].

Regulators outside the US have taken more sweeping action. Australia banned compounded tirzepatide and other compounded diabetes and weight-loss medicines entirely on May 21, 2024, citing "increasing reports of patients coming to harm," including one hospitalization ^[1]. Former FDA Commissioner Scott Gottlieb has also raised a separate concern: many compounded GLP-1 products use a "salt" formulation that is more soluble and may not deliver the extended-release effect of the weekly branded versions, meaning they may not work as expected even when not contaminated ^[1].

Why it matters for patients

Compounded semaglutide and tirzepatide have become a common option for people who cannot get or afford the brand-name drugs, especially during periods when Ozempic and Wegovy appeared on the FDA's drug shortage list ^[1]. But the lawsuits and lab findings suggest that what patients receive from some compounders may not be a reliable copy of the approved medicine. Products described as tirzepatide in Lilly's testing were sometimes different chemicals entirely, contaminated with bacteria, or the wrong color compared with the company's approved medicines, which are colorless ^[1]. Compounded drugs do not go through the FDA's premarket review for safety, effectiveness or quality that brand-name drugs undergo ^[1], so patients using them are relying on a different, less-verified system. The adverse event reports collected by the FDA, some involving hospitalization from dosing errors, indicate real harm has already occurred ^[1].

What happens next

Novo Nordisk's litigation campaign is ongoing, with 34 total actions and six permanent injunctions secured as of August 2024 ^[1]. Skovronsky has said the number of conditions treatable with incretin-based drugs is likely to grow, along with oral versions, which he expects will increase demand, shortages and compounding activity going forward ^[1]. It is not yet known from available sources how many of the 11 newly filed suits will result in injunctions or settlements, or whether the FDA will expand its warning-letter enforcement beyond the 10 letters issued since late 2023 ^[1].