FDA Reconsiders Decision on Eli Lilly's Weight Loss Drug Shortage

Background on FDA's Decision

The Food and Drug Administration (FDA) has announced it will reconsider the controversial decision to remove Eli Lilly's blockbuster weight loss and diabetes drug from its official shortage list. This move allows compounding pharmacies to continue producing their own versions amidst the ongoing demand for the medications.

Litigation and Regulatory Actions

A federal court in Texas granted the FDA's request to pause litigation regarding the removal of tirzepatide, which is marketed as Mounjaro for diabetes and Zepbound for obesity. The FDA sought to reassess its previous ruling, following a lawsuit that argued the drug remains in short supply.

• FDA will not take action against compounders while reevaluating its decision.
• Compounded medications are available at lower prices than branded versions.
• The agency has asked plaintiffs to provide further information on tirzepatide’s availability.

Industry Responses

Eli Lilly released a statement emphasizing the importance of patients using only FDA-approved medications, highlighting that compounded versions can pose risks due to lack of regulatory oversight. The company's spokesperson reiterated that all doses of their FDA-approved drugs are currently available.

Implications for Patients

The implications of the FDA's reconsideration are significant for patients who are struggling to access these important medications amidst persistent shortages. Should the FDA ultimately decide to reverse its original ruling again, the Outsourcing Facilities Association indicated they may return to court to protect patient access.