FDA To Reassess Ban On Cheaper, Compounded Versions of Eli Lilly Weight Loss Drugs

Zinger Key Points
  • FDA resolved tirzepatide shortage but may reconsider allowing compounders to produce copies amid criticism.
  • Eli Lilly issued cease-and-desist letters to companies copying its diabetes and weight loss drugs, Mounjaro and Zepbound.

The U.S. Food and Drug Administration (FDA) is reassessing a decision to ban compounding pharmacies to supply cheaper versions of Eli Lilly And Co’s LLY blockbuster weight loss and diabetes drugs.

What Happened: Reuters highlighted how the FDA had banned compounding pharmacies to supply cheaper versions of the medication, but is now reconsidering that decision.

The compounding groups Outsourcing Facilities Association and FarmaKeio Custom Compounding had filed a complaint against the FDA for the deciaion but the lawsuit has since been put on hold.

The complaint called the FDA’s decision to restrict the compounding of tirzepatide “a reckless and arbitrary decision […] to deprive patients of a vital treatment for type 2 diabetes and obesity.”

Last week, Eli Lilly said it issued hundreds of cease-and-desist letters to telehealth companies, compounding pharmacies, and medical spas, demanding they halt the production, sale, and promotion of products that imitate its drugs, Mounjaro and Zepbound.

The tirzepatide injection, branded as Mounjaro and Zepbound, has been in shortage since 2022.

Price Action: Lilly stock closed at $931.74 on Friday

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