Judge Blocks Compounded Copies of Diabetes Drugs in Key FDA Ruling

A U.S. federal judge has restricted compounding pharmacies from making copies of Eli Lilly's weight-loss and diabetes drugs due to a lawsuit against the FDA's decision that there's no longer a shortage of the active ingredient tirzepatide. The ruling impacts millions relying on compounded versions for affordability.

In a significant ruling, a U.S. federal judge has barred compounding pharmacies from manufacturing copies of Eli Lilly's widely prescribed weight-loss and diabetes drugs, Zepbound and Mounjaro. The decision responds to a lawsuit challenging the U.S. Food and Drug Administration's (FDA) conclusion that there's no longer a shortage of tirzepatide, the active ingredient.

Previously, due to the FDA's designation of a shortage, compounders were permitted to produce these medications en masse. However, the recent ruling mandates that smaller pharmacies immediately halt production, with larger outsourcing facilities having a deadline until March 19 to comply. These developments stem from the FDA's reliance on Eli Lilly's statements regarding supply sufficiency, which the compounders contest does not reflect patients' true access issues.

The Outsourcing Facility Association expressed shock over the court's decision, which was delivered under seal, leaving them unable to understand the judge's reasoning. Eli Lilly has welcomed the decision as a termination of mass compounding of its products, emphasizing collaboration with regulators to ensure compliance. This comes as compounded drug usage continues amidst insurers' partial coverage of obesity medications.

(With inputs from agencies.)