Judge rules against compounding group; Hims’ shares fall

From STAT’s Elaine Chen: A federal judge this week ruled against a compounding trade group that wanted to continue making copies of Eli Lilly’s obesity drug tirzepatide (sold under the brand names Mounjaro and Zepbound).

For background: The FDA last year took tirzepatide off its shortage list, which meant compounding pharmacies could no longer legally make copies of the branded treatment. But the Outsourcing Facility Association, a compounding trade group, sued the FDA, arguing that the agency’s move was arbitrary and unlawful. The trade group sought a preliminary injunction that would prevent the FDA from taking actions against its members making tirzepatide copies, but the judge has now denied the request. The judge’s order is sealed and could not be viewed by STAT.

In a statement, OFA chairman Lee Rosebush said the group is considering all of its options, including an appeal. He would not comment on any particular aspect of the order until it is unsealed by the court.

The ruling is a blow to compounders, which saw a surge in demand from patients over the last two years as patients could not access the branded treatments due to shortages and their high costs. The same trade group has also filed a lawsuit against the FDA for recently taking Novo Nordisk’s semaglutide (sold under the brand names Ozempic and Wegovy) off its shortage list.

Hims and Hers has been one of the most prominent telehealth companies connecting patients to compounded weight loss drugs.

Though it was not offering compounded tirzepatide and recently said it would stop making exact copies of semaglutide, the company said it will still prescribe other forms of compounded semaglutide “when there is clinical necessity for that personalization.” Though the judge’s ruling does not have a direct impact on Hims, it indicates the difficult legal environment for companies involved with compounding. Hims’ shares dropped 16% yesterday.

The ruling, meanwhile, represents a win for Lilly and Novo, which have both been trying to combat the rise of compounding. Both have started selling their drugs direct-to-consumer at a lower price, as a way to draw patients away from compounders. Just yesterday, the telehealth company Teladoc announced a new partnership with Lilly’s DTC platform that allows Teladoc users to get streamlined access to tirzepatide.

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