FDA to review removal of Eli Lilly weight loss drug from shortage list

The U.S. Food and Drug Administration (FDA) has agreed to reconsider its decision to remove tirzepatide, the active ingredient of Eli Lilly’s (NYSE:LLY) diabetes therapy Mounjaro and weight loss therapy Zepbound, from its shortage list.

In connection with a lawsuit filed by the trade group, the Outsourcing Facilities Association, the FDA said on Friday that until the review is complete, it would not take regulatory actions against compounding pharmacies and facilities making their versions of tirzepatide.

OFA, which represents makers of compounded drugs, said it is “greatly relieved, for our members and the many patients that they serve, that the FDA has agreed to reconsider its decision.”

The group filed the lawsuit on Monday, alleging that the FDA removed tirzepatide from its shortage list even though the popular injectable remained in short supply.

The U.S. District Judge Mark Pittman in Fort Worth, Texas, put the lawsuit on hold in response to the FDA’s decision.

Soaring demand for tirzepatide and semaglutide, the active ingredient of Novo Nordisk’s (NVO) weight loss therapy Wegovy, has fueled shortages, leading to a burgeoning compounding industry that operates under less severe regulatory oversight.

After the agency announced that the tirzepatide shortage was officially over last week, Hims & Hers Health (HIMS), which operates a compounding business targeting low-cost semaglutide, came under pressure.

Since then, WW International (WW) has also forayed into compounding to offer even cheaper semaglutide versions.