A turbulent series of events surrounding the supply of Eli Lilly’s blockbuster weight loss treatment has raised concerns around how the Food and Drug Administration maintains its list of drug shortages and which sources it relies on, an issue that affects a growing number of Americans.
Earlier this month, the FDA declared an end to the shortage of Lilly’s tirzepatide, sold as Mounjaro for diabetes and Zepbound for obesity, after almost two years. By law, that should have prohibited compound pharmacies from making copies of the drug, as they’re allowed to do so only when the treatment is on the shortage list.
However, some traditional retail pharmacies said supplies of Lilly’s treatment were still unavailable, and a trade group representing compounders took the FDA to court. The agency then made a sudden about-face, saying it would reconsider its decision and allow compounders to continue for the meantime. It marked the first time experts recall the FDA changing course about a shortage decision.
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