Eli Lilly loses case against Florida compounding pharmacy

Eli Lilly suffered another loss this week in its legal campaign against compounded versions of its popular diabetes and weight loss drug tirzepatide.

A Florida federal judge tossed Lilly’s lawsuit against a Miami compounding pharmacy on Wednesday, ruling that Lilly can’t “use state law as a back door to privately enforce” the Federal Food, Drug, and Cosmetic Act (FDCA). The decision comes just a couple months after another Florida judge dismissed a separate case Lilly brought against a different compounding pharmacy.

Compounded drugs are medicines that have been altered in some way to meet the special needs of a patient. While they aren’t FDA-approved, they are permitted in the US under certain circumstances — for example, if a patient can’t swallow a tablet and needs a liquid formulation. But Lilly argued in its recent lawsuit that RxCompoundStore.com is not genuinely compounding versions of its tirzepatide.

The pharma company accused the pharmacy of “simply unlawfully manufacturing prescription drugs without FDA approval.”

Lilly and rival GLP-1 manufacturer Novo Nordisk have brought a string of lawsuits against wellness centers and compounding pharmacies for what they believe is improper marketing of their diabetes and weight loss products.

Judge Roy Altman wrote in a Wednesday order that the federal government has “‘nearly exclusive’ authority to enforce the FDCA,” which was enacted in 1938 and calls for the FDA to oversee and regulate new drugs. The judge noted that “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.”

He cited Lilly’s “nearly identical” case against Wells Pharmacy Network, which was shot down in a different Florida federal court in February. Altman dismissed the case with prejudice, meaning Lilly cannot refile in that court, adding that “any amendment would be futile.”

Neither Lilly nor RxCompoundStore.com responded to requests for comment as of press time.

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