STAT+: Pharmalittle: We’re reading about Novo ending Hims deal, FDA transparency, and more

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so-familiar routine of meetings, deadlines, and messages has returned. But what can you do? There is no pause button to stop the world, such as it is, from spinning. So this means one thing: time to dig in to the tasks at hand. On that note, we have assembled a menu of tidbits to help you get started. Meanwhile, we have also fired up the coffee kettle for another cup of stimulation. Our choice today is marshmallow magic. Can you guess what gives it that magic feeling? In any event, we hope your day is simply smashing and, as always, do keep in touch if something juicy arises. …

Novo Nordisk is halting its collaboration with Hims & Hers Health over the sale of weight loss drugs, STAT says. The drugmaker argued the telehealth company engaged in “deceptive promotion” and sold “illegitimate, knockoff versions” of its Wegovy weight-loss treatment. Novo maintained that Hims & Hers Health “failed to adhere to the law which prohibits mass sales of compounded drugs under the false guise of personalization and are disseminating deceptive marketing that put patient safety at risk.” During the past two years when obesity treatments were in shortage, compounding pharmacies were allowed to make lower-priced copies for patients. But the U.S. Food and Drug Administration has now barred them from doing so, since the branded drugs are no longer deemed to be in shortage. Some compounders have tried to find workarounds by making what they call “personalized” GLP-1 drugs that have additives or are sold in different dosages than the branded treatments. Hims is among the telehealth companies that has continued to offer these “personalized” versions.

Recent FDA job cuts are making it more difficult to plan and run transparent meetings — and to ensure that the members of those committees do not have conflicts of interest, STAT reports. These are among the stated priorities of FDA Commissioner Marty Makary and U.S. Health and Human Services Secretary Robert F. Kennedy Jr. In April, HHS fired 3,500 workers at the FDA, including people working in roles that would seemingly help the administration achieve the stated goal of “radical transparency.” Workers processing requests under the Freedom of Information Act were let go, and then rehired a month later. But many of the advisory committee staff, including the drug center’s conflict of interest team, have not been brought back. Lawyers in the commissioner’s office now handle conflict of interest screenings. Already, at least three meetings have been postponed or canceled, including one on flu shots in February. Some FDA employees planning the meetings are stressed and perplexed by the depletion of resources, especially because of Makary’s public commitment to rooting out conflicts of interest.

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