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Eli Lilly Files Lawsuit Against Providers of Compounded Mounjaro and Zepbound

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An injection pen of Zepbound, Eli Lilly’s weight loss medication, was displayed in New York City on December 11, 2023.

Eli Lilly has initiated legal action against four telehealth providers accused of marketing compounded alternatives of its weight loss drug Zepbound and diabetes medication Mounjaro. This lawsuit represents the company’s ongoing effort to combat the rapidly expanding market for generic or imitation pharmaceuticals.

In the lawsuits filed on Wednesday, Lilly asserts that these telehealth companies—Mochi Health, Fella Health, Willow Health, and Henry Meds—are misleading consumers about the safety and approval of their products, steering them away from Lilly’s FDA-sanctioned medications.

The company contends that the telehealth firms are falsely advertising personalized treatment plans while distributing slightly modified versions of its drugs to bypass FDA regulations. Additionally, Lilly charges that some of the marketed products consist of formulations like oral tablets and drops that lack thorough clinical evaluation.

Attempts to obtain comments from Mochi, Fella, Willow, and Henry Meds were not immediately successful.

Lilly’s diabetes drug, Mounjaro, faced a supply shortage in late 2022, which permitted pharmacies to create compounded versions, a practice known as compounding. Similarly, Novo Nordisk’s weight loss drug Wegovy also experienced shortages, facilitating the emergence of compounded GLP-1 medications in the market.

This surge in online compounding occurred as consumers sought alternatives when brand-name drugs were unavailable or insurance coverage was lacking. Despite the FDA announcing the end of the drug shortage last month, some pharmacies continued to produce these compounded alternatives, which differ slightly enough to elude strict regulatory oversight.

Earlier this month, Lilly filed lawsuits against two pharmacies, accusing them of misrepresenting their products as personalized formulations that adhered to rigorous safety protocols and clinical testing.

One entity Lilly is legally challenging, Mochi Health, had plans to persist in selling compounded versions of tirzepatide, anticipating that their focus on personalized treatment would shield them from legal repercussions, according to CEO Myra Ahmad’s comments to CNBC in March.

When questioned about potential legal consequences from Lilly, Ahmad expressed confidence in the integrity of her prescribers, stating they maintain “established patient-physician relationships” and emphasized that “the beauty of medicine is really that they get full autonomy to decide what is the best way to manage their patients.”

In its court filings, Lilly claims that Ahmad is not a licensed healthcare provider and alleges that Mochi and its unlicensed owners exert excessive influence over the prescribing practices of doctors, thereby engaging in the “unlawful corporate practice of medicine.”

Lilly brings similar accusations against Fella Health, asserting that the company has made “sweeping corporate decisions that dictate patient care,” even modifying prescriptions for multiple patients from one formulation of tirzepatide to another with additional components.

In all four lawsuits, Lilly seeks to prohibit the companies from advertising or selling tirzepatide. However, it may take an extended period for these cases to progress through the judicial system.

Source
www.cnbc.com

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