Houston-based Empower Pharmacy is certainly one of two compounding pharmacies sued by the pharmaceutical big Eli Lilly earlier this month for allegedly promoting “knockoff” variations of its weight reduction and diabetes medication.
Eli Lilly filed the lawsuit towards Empower Pharmacy within the District Courtroom of New Jersey on April 1. In accordance with courtroom paperwork, Eli Lilly accuses Empower Pharmacy of allegedly promoting probably harmful variations of its medication Mounjaro and Zepbound — two injectable medicines containing Tirzepatide. Empower Pharmacy produces each an injectable and pill type of its Tirzepatide drug.
“Empower makes and sells two tirzepatide knockoff medication that deceive shoppers into believing they’re buying medicines which can be secure and efficient to deal with their weight problems,” Eli Lilly claims within the lawsuit. “Tirzepatide is the energetic ingredient present in Lilly’s Mounjaro and Zepbound, that are the one FDA-approved Tirzepatide medicines.”
Eli Lilly claims that since Empower’s “Tirzepatide ODT” has not gone by means of the identical approval course of, it’s probably unsafe.
“Tirzepatide ODT, against this, is an untested knockoff that exposes sufferers to security dangers with none scientific knowledge displaying that it even works,” Eli Lilly claims within the lawsuit. “By promoting Tirzepatide ODT, Empower is actually conducting a mass testing experiment on shoppers.”
Empower Pharmacy didn’t instantly reply to a request for remark Tuesday, however claims on its web site that it’s an FDA-registered 503B outsourcing facility. In accordance with the FDA, outsourcing services that comply underneath part 503B will not be required to obtain FDA approval of their compounded drug merchandise.
Nevertheless, the FDA additionally stated that 503B “Registration of an outsourcing facility doesn’t imply that FDA has decided that the outsourcing facility is in compliance with CGMP necessities or that it has met the situations for its drug merchandise to qualify for the exemptions underneath part 503B.”
On April 2, the FDA despatched a warning letter to Empower Pharmacy claiming that it failed to satisfy the situations of part 503B following an inspection.
Eli Lilly’s authorized actions towards Empower and different compounding pharmacies come a number of months after the FDA introduced {that a} scarcity of Mounjaro and Zepbound had been resolved.
Mounjaro and Zepbound gained immense recognition in 2024 after the medication’ means to advertise weight reduction.
This prompted a nationwide scarcity of the medication. In response to the scarcity, the FDA permitted compounded variations of the brand-name medication to be produced, in keeping with the Related Press.
In a press release to Houston Public Media, an Eli Lilly spokesperson stated Empower Pharmacy had already been instructed by the FDA to cease manufacturing of its Tirzepatide ODT.
“FDA and a federal courtroom have each made clear that compounders ‘should stop manufacturing’ of compounded tirzepatide knockoffs,” the spokesperson stated in a press release. “Anybody persevering with to promote mass compounded tirzepatide, together with by referring to it as ‘customized,’ ‘tailor-made’ or one thing related, is breaking the legislation and deceiving sufferers. We’ll proceed to take motion to cease these unlawful actors and urgently name on regulators and legislation enforcement to do the identical.”
In February, a number of compounding pharmacies sued the FDA for eradicating Mounjaro, Zepbound and different related name-brand medicines from the scarcity checklist, in keeping with Reuters.
As of Tuesday, Empower Pharmacy had not filed a response to Eli Lilly’s lawsuit. The Houston-based pharmacy has till April 24 to reply, courtroom data present.
Eli Lilly additionally sued Attempt Pharmacy for related accusations.
