Lilly asks to join GLP-1 compound lawsuit

Eli Lilly filed a motion on Jan. 1 to join a lawsuit over whether compounding pharmacies can make and sell copies of its GLP-1 drugs, arguing that it needs to participate in the case to defend its interests.

The Outsourcing Facilities Association, which represents sites that manufacture compounded medications, and Texas-based compounding pharmacy FarmaKeio Custom Compounding filed the lawsuit in October. The plaintiffs are suing the FDA for removing tirzepatide, the GLP-1 drug that Lilly sells as Mounjaro and Zepbound, from the agency’s shortage list that month. While tirzepatide was on the shortage list, compounding pharmacies could legally manufacture and sell the patent-protected drug to meet demand. In December, the FDA aware a declaratory order confirming the end of the shortage and giving compounding pharmacies 60 to 90 days to stop manufacturing tirzepatide.

Lilly’s request to intervene, which was the first reported by Reutersmaintains that the lawsuit could affect its interests and that none of the existing parties adequately represents those interests. The FDA is the defendant in the case, but Lilly identified areas where its interests diverge from those of the agency.

“While Lilly has no doubt that the FDA will defend its declaratory order, the FDA has different interests than Lilly, as the FDA is a government agency charged with managing the policy goals and objectives of the federal government, creating a reasonable possibility that the FDA will not ‘adequately represent (Lilly’s) interests,’” the drugmaker wrote in its legal filing.

Lilly is also concerned that the FDA may disagree with its interpretation of a section of the Food, Drug, and Cosmetic Act on drug compounding. The company states that the law does not allow compounding pharmacies to “manufacture copies of commercially available pharmaceutical products, and that conclusion is in no way dependent on whether tirzepatide is currently on the shortage list.”

The law says state-licensed pharmacists can make “essentially a copy” of an FDA-approved drug if the product is not “commercially available,” Lilly said. Citing “legislative history and legal text,” Lilly said “commercial availability is not the same as drug shortages,” but the FDA may see things differently.

“Plaintiffs have alleged that the 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 said. “If the plaintiffs are correct, neither party in this litigation adequately represents Lilly’s interest in seeing the proper application of section 503A to tirzepatide.”

The lawsuit advances in parallel with regulatory actions. The FDA has given State-licensed pharmacists or physicians who compound under section 503A until February 18 to stop manufacturing tirzepatide. Subcontracting facilities, which are covered by section 503B of the law, have until March 19 to stop production. the demand represents a challenge to the FDA’s power to remove therapies from the drug shortage list.