(Reuters) – Eli Lilly has issued cease-and-desist orders to U.S. healthcare providers in a bid to halt the promotion of compounded versions of its weight-loss and diabetes medications, amid a surge in the supply of these unauthorized alternatives, the company announced on Wednesday.
The pharmaceutical giant has targeted telehealth companies, wellness centers, and medical spas that have been selling compounded versions of its popular drugs, Zepbound and Mounjaro, according to a company spokesperson. These compounded drugs are custom-made and often marketed as cheaper alternatives to the original FDA-approved treatments.
In an email statement, Lilly emphasized the legality of its action, stating, “When FDA-approved medicines are ‘commercially available,’ compounders cannot regularly make ‘essentially a copy’ of them.”
Zepbound and Mounjaro, both known chemically as tirzepatide, had been in short supply, which allowed licensed pharmacies in the U.S. to legally produce compounded versions. However, the escalating demand for Lilly’s and Danish competitor Novo Nordisk’s weight-loss drugs—often priced at over $1,000 for a month’s supply—has led to the proliferation of lower-priced, compounded versions.
Lilly, along with Novo Nordisk, has previously initiated legal action against more than three dozen medical spas, weight-loss clinics, compounding pharmacies, and online sellers to prevent them from selling products that claim to contain the active ingredients in their drugs.
Despite Lilly’s efforts, the U.S. Food and Drug Administration (FDA) still lists all doses of Lilly’s drugs as available, though they have not yet been removed from the shortage list. The FDA is currently evaluating whether the available supply of tirzepatide, the key ingredient in Mounjaro and Zepbound, meets the criteria for a resolved shortage.
The FDA also issued a warning last month to patients and healthcare providers regarding the risks associated with compounded versions of Novo Nordisk’s weight-loss and diabetes drugs. The warning highlighted reports of adverse events, some of which required hospitalization, due to dosing errors linked to the self-administration of compounded drugs and healthcare providers’ miscalculations.
This ongoing conflict between major pharmaceutical companies and sellers of compounded drugs underscores the broader issues of drug accessibility, pricing, and patient safety.
