The Eli Lilly logo can be seen at one of the company’s offices located in San Diego, California, on September 17, 2020.
Mike Blake | Reuters
Eli Lilly has initiated legal action against two pharmacies, accusing them of compounding Zepbound and Mounjaro in violation of FDA regulations and diverting customers from Lilly’s medications.
In complaints lodged on Tuesday in Delaware and New Jersey, Lilly contends that Strive Pharmacy and Empower Pharmacy are misleadingly promoting their products as customized versions of clinically validated drugs, produced under strict safety protocols. According to Lilly, this marketing strategy is encouraging patients to turn to compounded drugs instead of their FDA-approved options.
In response, Empower stated that limiting access to personalized alternatives to commercial medications is detrimental to patients, asserting its commitment to providing these transformative formulations. Strive characterized Lilly’s lawsuit as a typical case of a major pharmaceutical company overstepping boundaries to safeguard its interests, pledging to mount a robust defense.
Compounding pharmacies and outsourcing facilities were largely expected to cease the production of their own tirzepatide versions— the active component in Lilly’s Zepbound and Mounjaro— after the FDA ruled that branded options were no longer in short supply. Nevertheless, some have continued compounding, making adjustments to dosages and blending them with vitamins, thereby differentiating their products from Lilly’s and potentially circumventing the FDA’s ban.
A Zepbound injection pen, Eli Lilly’s weight-loss medication, is showcased in New York City on December 11, 2023.
Brendan McDermid | Reuters
Lilly asserts that Strive and Empower are simply producing bulk modified versions of tirzepatide rather than creating personalized formulations. Branded drugs may be compounded on a larger scale only when they are in shortage; otherwise, custom versions can be produced for individual circumstances, such as for patients with ingredient allergies or those unable to take the standard drug form.
Strive and Empower distribute tirzepatide to well-known telehealth platforms, including Lavender Sky Health and Mochi Health. In a statement, Mochi indicated that it does not foresee any disruptions or delays in patient care as a result of the lawsuit and maintains confidence in its clinical approach. Lavender Sky Health did not respond to a request for comments.
We are dedicated to delivering safe, evidence-driven treatments that prioritize our patients’ health and well-being above all else. We do not predict any interruptions or delays in patient care due to this lawsuit and remain confident in our clinical integrity.
This legal action will serve as a significant test for Lilly’s capacity to confront compounding pharmacies in court, especially now that Zepbound and Mounjaro are no longer listed as in short supply by the FDA. These lawsuits may also create a precedent for Novo Nordisk, whose weight-loss drug Wegovy and diabetes treatment Ozempic generally cannot be compounded after the end of May.
Eli Lilly has initiated legal proceedings against two pharmacies, Strive Pharmacy and Empower Pharmacy, alleging that they are unlawfully compounding versions of its drugs Zepbound and Mounjaro. Lilly argues that these pharmacies are bypassing the Food and Drug Administration’s (FDA) regulations and enticing patients to use their compounded products over Lilly’s FDA-approved options.
The lawsuits were filed in Delaware and New Jersey, highlighting that both Strive and Empower are marketing their compounded drugs as personalized alternatives, which Lilly contends misleads patients into believing that these versions match the rigor of clinical testing and safety standards applied to Lilly’s pharmaceuticals. The company claims that these marketing practices diminish the appeal of its FDA-approved treatments.
In response to the lawsuits, Empower Pharmacy has maintained that providing personalized alternatives to standard commercial drugs is vital for patient welfare and asserted its commitment to offering such formulations. Strive Pharmacy characterized Lilly’s legal actions as an overreach by a major pharmaceutical company that prioritizes its interests over patient access. The pharmacies have indicated their intention to mount a vigorous defense against Lilly’s claims.
Under FDA regulations, compounding pharmacies and outsourcing facilities are permitted to create customized drug formulations under specific circumstances, such as when patients have allergies or cannot tolerate conventional medication formats. However, a recent FDA determination lifted the shortage designation for Zepbound and Mounjaro, which supposedly led to an end to the compounding of tirzepatide—the active ingredient in these medications. Despite this ruling, some pharmacies, including Strive and Empower, continued compounding by modifying dosages or combining the drug with vitamins, actions Lilly argues are simply mass production rather than true personalization.
Both Strive and Empower serve various telehealth platforms, such as Lavender Sky Health and Mochi Health. Mochi Health has commented on the lawsuit, indicating it does not expect any interruptions in patient care and maintains confidence in their clinical practices. Lavender Sky Health has yet to respond to inquiries.
The legal actions mark a significant moment for Lilly, as they represent the first effort to challenge compounding pharmacies since the FDA’s status change for Zepbound and Mounjaro. The outcomes of this litigation could become a critical reference point for other pharmaceutical companies, including Novo Nordisk, whose weight-loss and diabetes treatments such as Wegovy and Ozempic are similarly affected by compounding regulations.
Overall, this situation underscores the tension between pharmaceutical companies and compounding pharmacies. On one side, Eli Lilly seeks to uphold the value and market position of its FDA-approved treatments, emphasizing the importance of regulatory compliance and patient safety. On the other hand, compounding pharmacies argue for the necessity of personalized treatment options, suggesting that a rigid adherence to FDA restrictions may restrict patient access to tailored healthcare solutions.
As the case progresses, developments will likely influence future interactions between large pharmaceutical entities and compounding pharmacies, shaping how treatments are provided and perceived in the healthcare market. Both Eli Lilly’s actions and the responses from Strive and Empower highlight a broader debate within the healthcare industry regarding the balance between innovation, regulation, and patient choice.
