Compounders File Lawsuit Against FDA for Excluding Eli Lilly’s Tirzepatide from Shortage List

The Food and Drug Administration (FDA) has delisted Eli Lilly’s tirzepatide from the shortage list, leading to compunders suing the FDA.

An industry group that deals in compounding products sued the FDA after the agency revoked Lilly’s Mounjaro and Zepbound tirzepatide-based drugs shortage list. The group also says the FDA administration is reckless and arbitrary, as it fails to offer a lawful and proper procedure for banning products. 

Formed and lodged in U.S. District Court in Fort Worth, Texas, the Outsourcing Facilities Association (OFA) accuses the FDA of acting illegally and asks it to rescind the decision. The group also would like an order to restrain the FDA from taking punitive actions against compounders that are making tirzepatide until the current litigation is decided.

The lawsuit complains that the FDA neglected to solicit comments on the matter before reaching its conclusion and that it simply took Eli Lilly’s word that it could handle demand. The suit claims that Lilly has every reason to control the tirzepatide market since it has emerged as a lucrative treatment for both diabetes and obesity. OFA Chairman Lee Rosebush explored the issues arising from FDA action to generate broader impacts such as to the recently affected patients along with physicians and the compounding pharmacies that invested in a development to meet increasing demands due to product shortages and delays.

The FDA refused to speak on the ongoing legal cases.

Mounjaro’s generic copies in the form of compounding pharmacies were first allowed to be produced when the FDA listed tirzepatide as a drug in shortage at the end of 2022. Another drug to be added to the shortage list was Zepbound – an obesity medication – in April this year. These compounded versions have become preferred due to their relatively cheaper and more accessible prices as customers 23 seek these treatments more.

However, when a drug is no longer on the FDA’s shortage list small compounders must stop compounding right away and large compounders who are operating under section 503B of the Food, Drug, and Cosmetic Act have sixty days to stop.

Manufacturers who mimic other substances can still make products similar to Novo Nordisk’s semaglutide which has been on the shortage list since August 2022. The shortages, which may present a challenge to Novo Nordisk’s sales of Ozempic, consisting of semaglutide, extend into the year-end.

It is supported by FarmaKeio Superior Custom Compounding, which the FDA has accused of sterile product recalls and failure to meet regulatory requirements this year.