FDA Reconsiders Decision on Compounded Diabetes Drugs Amid Legal Pressure

The FDA has agreed to revisit its decision to prevent compounders from selling versions of Eli Lilly's diabetes and weight loss medications. The federal agency will allow compounding pharmacies to provide these drugs while investigating a potential shortage of their active ingredient, tirzepatide.

The U.S. Food and Drug Administration has decided to reassess its previous stance barring drug compounders from distributing alternative versions of Eli Lilly's popular diabetes and weight loss medications. This reconsideration, announced on Friday, permits compounding pharmacies to continue supplying the drugs pending a review of their active ingredient's availability.

In response to a legal challenge filed by the Outsourcing Facilities Association, a compounding industry advocate, U.S. District Judge Mark Pittman has paused the lawsuit following the FDA's decision. The issue arose after the regulatory agency removed the active ingredient, tirzepatide, from its list of shortages, threatening affordable access for many patients.

Compounded drugs, unlike their brand-name counterparts, do not require prior FDA approval, but can be produced if a drug is in short supply. The lawsuit argues that tirzepatide still faces shortages, and Eli Lilly has taken legal actions against entities selling non-FDA approved versions of its products.

(With inputs from agencies.)