FDA Reconsiders Sale of Compounded Diabetes and Weight Loss Drugs

The FDA has decided to reconsider its previous decision that barred drug compounders from selling their versions of Eli Lilly's weight loss and diabetes drugs. This comes after a lawsuit by the Outsourcing Facilities Association. The reconsideration allows continued access to cheaper drug alternatives amid ingredient shortages.

The U.S. Food and Drug Administration has opted to review its earlier stance, which prohibited drug compounders from selling their versions of Eli Lilly's popular weight loss and diabetes treatments. The agency's move comes in light of a lawsuit filed by the Outsourcing Facilities Association, representing the compounding industry.

Under this reconsidered policy, pharmacies and facilities can continue distributing compounded versions as the FDA assesses whether there's a shortage of the active ingredient, tirzepatide. These compounded alternatives provide a more affordable option compared to brand-name counterparts. The federal review temporarily halts the legal proceedings initiated against the FDA's previous decision.

Persistent shortages of Lilly's drugs, alongside high demand for affordable alternatives, have prompted a reassessment of drug accessibility rules. While compounded drugs bypass standard FDA approval, federal guidelines permit their sale when genuine shortages occur. Meanwhile, Lilly has taken legal action against unauthorized sellers of its brand-name drugs.

(With inputs from agencies.)