Introduction to the Lawsuit
Eli Lilly, a pharmaceutical giant, has filed a lawsuit against Empower Pharmacy, a Houston-based compounding pharmacy, for allegedly selling "knockoff" versions of its weight loss and diabetes drugs. The lawsuit, filed in the District Court of New Jersey on April 1, claims that Empower Pharmacy is producing and selling potentially dangerous versions of Eli Lilly’s injectable medications, Mounjaro and Zepbound, which contain the active ingredient Tirzepatide.
The Accusations
Eli Lilly accuses Empower Pharmacy of deceiving consumers into believing they are purchasing safe and effective medicines to treat their obesity. The pharmaceutical company claims that Empower Pharmacy’s Tirzepatide ODT, an injectable and tablet form of the drug, has not gone through the same approval process as Mounjaro and Zepbound, making it potentially unsafe for consumption. Eli Lilly states that "Tirzepatide ODT is an untested knockoff that exposes patients to safety risks without any clinical data showing that it even works."
Empower Pharmacy’s Response
Empower Pharmacy claims to be an FDA-registered 503B outsourcing facility, which means it is not required to receive FDA approval for its compounded drug products. However, the FDA has stated that registration does not guarantee compliance with Good Manufacturing Practice (GMP) requirements or exemption under section 503B. On April 2, the FDA sent a warning letter to Empower Pharmacy, claiming that it failed to meet the conditions of section 503B following an inspection.
Background on the Shortage
The lawsuit comes several months after the FDA announced that a shortage of Mounjaro and Zepbound had been resolved. The drugs gained popularity in 2024 due to their ability to promote weight loss, causing a nationwide shortage. In response, the FDA permitted compounded versions of the brand-name drugs to be produced.
Eli Lilly’s Statement
An Eli Lilly spokesperson stated that Empower Pharmacy had already been told by the FDA to stop production of its Tirzepatide ODT. The spokesperson emphasized that "FDA and a federal court have both made clear that compounders ‘must cease production’ of compounded tirzepatide knockoffs" and that Empower Pharmacy is "breaking the law and deceiving patients" by continuing to sell the drug.
Other Developments
In February, several compounding pharmacies sued the FDA for removing Mounjaro, Zepbound, and other similar name-brand medications from the shortage list. As of Tuesday, Empower Pharmacy had not filed a response to Eli Lilly’s lawsuit and has until April 24 to do so. Eli Lilly has also sued Strive Pharmacy for similar accusations.
Conclusion
The lawsuit between Eli Lilly and Empower Pharmacy highlights the ongoing debate between pharmaceutical companies and compounding pharmacies. While Empower Pharmacy claims to be operating within the bounds of FDA regulations, Eli Lilly argues that the pharmacy’s actions are putting patients at risk. The outcome of this lawsuit will likely have significant implications for the pharmaceutical industry and the production of compounded medications. As the case continues to unfold, it is essential to prioritize patient safety and ensure that medications are produced and distributed in a safe and regulated manner.
