Eli Lilly has filed a motion to intervene in an ongoing legal dispute between compounding pharmacies and the U.S. Food and Drug Administration (FDA) over the production of tirzepatide, the active ingredient in the company's blockbuster GLP-1 medications Mounjaro and Zepbound.
The pharmaceutical giant submitted its request on January 1, arguing that it needs to participate in the lawsuit to protect its interests, which it claims are not adequately represented by the existing parties.
Legal Battle Over Compounded GLP-1 Medications
The lawsuit was initially filed in October by the Outsourcing Facilities Association and Texas-based FarmaKeio Custom Compounding against the FDA. The plaintiffs are challenging the agency's decision to remove tirzepatide from its drug shortage list that same month.
While tirzepatide was listed as being in shortage, compounding pharmacies were legally permitted to produce and sell versions of the patent-protected drug to meet market demand. However, in December, the FDA issued a declaratory order confirming the end of the shortage and established a timeline for compounding pharmacies to cease production.
In its filing, Lilly identified several areas where its interests diverge from those of the FDA, despite both entities supporting the end of compounded tirzepatide production.
"While Lilly has no doubt that FDA will defend its declaratory order, FDA has different interests than Lilly as FDA is a government agency tasked with administering the policy goals and objectives of the federal government, creating a reasonable possibility that FDA will not 'adequately represent [Lilly's] interest[s],'" the company stated in its legal documents.
Dispute Over Interpretation of Compounding Laws
A key point of contention involves the interpretation of the Food, Drug and Cosmetic Act regarding drug compounding. Lilly asserts that the law fundamentally prohibits compounding pharmacies from manufacturing copies of commercially available drug products, regardless of whether the medication appears on a shortage list.
The company's legal argument centers on the distinction between "commercial availability" and "drug shortage" status. According to Lilly, citing "legislative history and statutory text," these are separate concepts under the law.
"Plaintiffs have alleged that FDA disagrees and has chosen to allow compounding pharmacies to mass-manufacture copies of commercially available drugs if they are on the shortage list," Lilly stated. "If Plaintiffs are correct, no party in this litigation adequately represents Lilly's interest in seeing the appropriate application of section 503A for tirzepatide."
Regulatory Deadlines Approaching
While the legal battle unfolds, the FDA has established firm deadlines for ending compounded tirzepatide production. State-licensed pharmacists or physicians compounding under section 503A have until February 18 to stop making the drug, while outsourcing facilities operating under section 503B have until March 19.
The case represents a significant challenge to the FDA's authority to manage its drug shortage list and regulate compounding activities. For Lilly, whose GLP-1 medications have become major revenue drivers, the outcome could have substantial commercial implications.
Market Impact and Supply Considerations
Tirzepatide has emerged as one of the pharmaceutical industry's most in-demand medications, with Mounjaro approved for type 2 diabetes and Zepbound for weight management. The drugs' popularity has created persistent supply challenges, which initially led to the shortage designation.
The lawsuit highlights the tension between protecting pharmaceutical innovation through patent enforcement and ensuring patient access to medications during periods of high demand. Compounding pharmacies argue they provide a necessary service during shortages, while Lilly maintains that its intellectual property rights and quality control standards must be protected.
As the case proceeds, healthcare providers and patients using these medications will be watching closely to see how the court's decision might affect future availability and access to GLP-1 receptor agonists, a drug class that has revolutionized treatment approaches for diabetes and obesity.
