Lilly asks to join lawsuit over compounded versions of its weight-loss drugs

Key Points

  • Eli Lilly has requested to join a lawsuit against the FDA regarding the agency's decision that there is no longer a shortage of Lilly’s weight-loss and diabetes drugs.
  • The lawsuit, filed by compounding pharmacies, challenges the FDA's decision which impacts the production and sale of cheaper, compounded versions of Lilly’s drugs Zepbound and Mounjaro.
  • Lilly argues that it needs to defend its interests directly as it cannot rely solely on the FDA to protect its position in court.

Summary

Eli Lilly has moved to intervene in a lawsuit against the U.S. Food and Drug Administration (FDA) concerning the agency's decision that there is no longer a shortage of Lilly’s weight-loss and diabetes drugs, Zepbound and Mounjaro. The lawsuit, initiated by compounding pharmacies and the Outsourcing Facilities Association, challenges the FDA's October decision, which restricts the production of cheaper, compounded versions of these drugs. Despite the FDA's initial reconsideration and subsequent reaffirmation of no shortage, the compounding industry seeks a court order to reverse this decision. Lilly's involvement stems from its need to protect its interests, as it believes the FDA might not appeal an unfavorable court ruling. Additionally, Lilly has concerns about the legality of compounded drug production by smaller pharmacies even during shortages, a stance potentially at odds with the FDA's views. Meanwhile, the market for compounded versions of similar drugs like Wegovy remains significant, driven by cost considerations for patients not covered by insurance for weight-loss treatments.

cnbc
January 2, 2025
Stocks
Read article

Related news