A drug compounding industry group filed a lawsuit against the U.S. Food and Drug Administration (FDA) on Monday over its decision to remove Eli Lilly’s popular weight-loss medications and diabetes drugs from the federal drug shortage list.
The lawsuit, filed by the Outsourcing Facilities Association in a Fort Worth, Texas federal court, challenges the FDA’s removal of tirzepatide. Tirzepatide is the active ingredient in Lilly’s Mounjaro (for diabetes) and Zepbound (for weight loss), despite ongoing supply shortages.
A tirzepatide injection is used to treat type 2 diabetes. Together with diet and exercise, it can help control your blood sugar. Tirzapatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. A tirzepatide injection can also help lose weight in patients with obesity caused by certain conditions.
Related: Obesity Evaluation and Treatment Course
Monopolizing the weight-loss medications market?
The association claims that the FDA based its decision on assurances from Eli Lilly, accusing the agency of acting in an “arbitrary and capricious” manner by trusting the company’s projections without public input. The lawsuit argues that Lilly has a vested interest in monopolizing the market, raising concerns about the FDA’s reliance on the company’s self-reported ability to meet demand.
Mounjaro has been on the FDA’s shortage list since late 2022, with Zepbound added in April. Compounding facilities, which create medications by altering ingredients, are allowed to produce compounded versions of drugs during shortages. If the FDA’s decision stands, these facilities may no longer be able to supply alternative versions of the drugs.
Related: Primary Care Management of Patients Post-Weight-Reduction Surgery
Neither the FDA nor Eli Lilly have responded to the lawsuit or requests for comment. Meanwhile, Novo Nordisk’s semaglutide, another weight-loss drug, remains on the shortage list. Semaglutide is an antidiabetic medication used for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management.
