No More Shortages: FDA Clears Lilly's Weight-Loss Drug

The U. S. Food and Drug Administration (FDA) announced that there are no longer shortages of Eli Lilly’s popular weight-loss and diabetes drugs. This decision stops the widespread sale of cheaper, unapproved copies made by compounding pharmacies. The FDA will not take action against these pharmacies for the next 60 to 90 days, though, giving them time to transition patients to FDA-approved medicines. Compounding pharmacies previously relied on the FDA's shortage list to legally reproduce these drugs. In October, the FDA first declared an end to the shortage but hesitated later, surprising many businesses and pharmacies. Lilly encourages people to stop using and selling unapproved versions of their drug, tirzepatide, marketed as Zepbound for weight loss and Mounjaro for diabetes. However, not everyone agrees with the FDA’s decision. Scott Brunner, CEO of the Alliance for Pharmacy Compounding, believes the data might not be complete enough to claim the shortage is over. Despite this, Novo Nordisk’s rival weight-loss drug, Wegovy, is still listed as in shortage.

Compounded versions of Wegovy are widely used, with hundreds of thousands of patients taking them, according to an Alliance survey. Telehealth company Hims & Hers Health offers these versions but declined to comment, with its shares dropping after the FDA’s announcement. This move by the FDA might signal the end of cheap, unapproved drug versions. The decision could affect prescription volumes only modestly in 2025, according to Bernstein analyst Courtney Breen. Lilly has been defending its drug supply claims in court, arguing that it can meet demand without public input. Many patients pay out of pocket for cheaper, compounded versions of these drugs because insurers often don’t cover them for weight loss. Lilly has been cracking down on companies selling compounded versions, sending cease-and-desist letters and filing lawsuits.

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