Lilly Suffers Legal Loss in Tirzepatide Case Against Compounding Pharmacy

 Lilly Biotechnology Center in San Diego, CA

Pictured: Eli Lilly's Biotechnology Center in San Diego, California/iStock, JHVEPhoto

A Florida judge on Tuesday dismissed Eli Lilly’s case against a compounding pharmacy, finding that the drugmaker cannot use state law in its campaign against reformulated versions of the company’s top-selling weight-loss and diabetes medication tirzepatide.

U.S. District Judge Roy Altman wrote in his ruling that in asking the courts to bar the defendant—a compounding pharmacy named RXCompoundStore.com—from marketing its own compounded version of tirzepatide, Lilly is trying to preempt federal law.

“We think Eli Lilly is using state law to enforce the terms of the FDCA [Federal Food, Drug, and Cosmetic Act], which … is a task generally ‘reserve[d] to the FDA,’” Altman wrote, adding that the court will not allow Lilly “to use state law as a back door to private enforce the FDCA.”

“As the Supreme Court has made clear, ‘the FDCA and its regulations provide the United States with nearly exclusive enforcement authority,’” the judge’s ruling states. “Given the federal government’s ‘nearly exclusive’ authority to enforce the FDCA, courts around the country have generally refused to encroach on that authority by adjudicating claims that a party has (or has not) complied with the FDCA.”

Lilly launched its legal offensive against several compounding pharmacies in September 2023, alleging that RXCompoundSTore.com—along with other compounding pharmacies that are defendants in separate lawsuits—were violating the FDCA by selling altered versions of tirzepatide that have not yet been approved by the FDA.

Compounded drugs refer to medicines that have been chemically altered or combined with other components. These altered versions of drugs can have drastically different tolerability, safety and efficacy profiles. While the FDA cannot guarantee the quality of compounded drugs, their use is permitted under some niche circumstances, like when a patient is allergic to one component of an approved drug.

At the time of the filing of the lawsuits, Lilly said that the compounded forms of tirzepatide may pose health risks to consumers, and that the lawsuits aimed to “protect patient safety and stop the unlawful marketing and sale of non-FDA approved compounded products.”

Lilly competitor Novo Nordisk, which markets Ozempic and Wegovy, has also been going after compounding pharmacies and wellness clinics for selling altered version of semaglutide. The pharma has filed at least two rounds of legal complaints—one in June 2023 and another in July—seeking to block the sale of these counterfeit products.

In February 2024, the Danish drugmaker claimed an early victory in its legal campaign, with a Miami court in the Southern District of Florida issuing a permanent injunction against Ekzotika Corporation, blocking it from suggesting that any of its compounded semaglutide products are authentic or approved by the FDA.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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