Eli Lilly Seeks to Intervene in FDA Lawsuit Over Compounded Tirzepatide to Safeguard Interests

Eli Lilly's Legal Move:
Eli Lilly has filed a motion to join a lawsuit between a compounding pharmacy trade group and the FDA over the agency's decision regarding compounded versions of tirzepatide, a weight loss drug235.

Reason for Intervention:
Lilly aims to protect its interests, as it cannot be certain that the FDA will adequately defend its rights in the lawsuit25.

FDA Concerns:
The FDA has expressed concerns about unapproved GLP-1 drugs used for weight loss, including compounded versions of semaglutide and tirzepatide, due to reports of adverse events and dosing errors1.

Adverse Events:
The FDA has received numerous reports of adverse events related to compounded semaglutide and tirzepatide, including nausea, vomiting, diarrhea, abdominal pain, and constipation1.

Regulatory Issues:
The FDA has warned against the illegal sale of unapproved drugs containing semaglutide, tirzepatide, or retatrutide, which are falsely labeled as "for research purposes" or "not for human consumption"1.

Legal Battle:
Compounding pharmacies face an uphill battle in the fight over tirzepatide, with Eli Lilly's intervention adding a new layer of complexity to the legal proceedings35.

Sources:

1. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss

2. https://www.fidelity.com/news/article/default/202501021412RTRSNEWSCOMBINEDL1N3NY0IR1

3. https://endpts.com/compounding-pharmacies-face-an-uphill-battle-in-fight-over-tirzepatide/

5. https://endpts.com/eli-lilly-seeks-to-join-lawsuit-over-end-of-tirzepatide-shortage/