Good morning, everybody, and welcome to a different working week. We hope the weekend respite was enjoyable and invigorating, as a result of that oh-so-familiar routine of conferences, deadlines, and messages has returned. However what are you able to do? There is no such thing as a pause button to cease the world, comparable to it’s, from spinning. So this implies one factor: time to dig in to the duties at hand. On that word, we now have assembled a menu of tidbits that will help you get began. In the meantime, we now have additionally fired up the espresso kettle for one more cup of stimulation. Our alternative as we speak is marshmallow magic. Are you able to guess what offers it that magic feeling? In any occasion, we hope your day is just smashing and, as all the time, do communicate if one thing juicy arises. …
Novo Nordisk is halting its collaboration with Hims & Hers Well being over the sale of weight reduction medication, STAT says. The drugmaker argued the telehealth firm engaged in “misleading promotion” and offered “illegitimate, knockoff variations” of its Wegovy weight-loss remedy. Novo maintained that Hims & Hers Well being “failed to stick to the regulation which prohibits mass gross sales of compounded medication beneath the false guise of personalization and are disseminating misleading advertising that put affected person security in danger.” Throughout the previous two years when weight problems therapies have been in scarcity, compounding pharmacies have been allowed to make lower-priced copies for sufferers. However the U.S. Meals and Drug Administration has now barred them from doing so, for the reason that branded medication are now not deemed to be in scarcity. Some compounders have tried to search out workarounds by making what they name “customized” GLP-1 medication which have components or are offered in several dosages than the branded therapies. Hims is among the many telehealth corporations that has continued to supply these “customized” variations.
Current FDA job cuts are making it tougher to plan and run clear conferences — and to make sure that the members of these committees don’t have conflicts of curiosity, STAT experiences. These are among the many said priorities of FDA Commissioner Marty Makary and U.S. Well being and Human Providers Secretary Robert F. Kennedy Jr. In April, HHS fired 3,500 employees on the FDA, together with individuals working in roles that will seemingly assist the administration obtain the said aim of “radical transparency.” Staff processing requests beneath the Freedom of Data Act have been let go, after which rehired a month later. However most of the advisory committee workers, together with the drug middle’s battle of curiosity group, haven’t been introduced again. Attorneys within the commissioner’s workplace now deal with battle of curiosity screenings. Already, no less than three conferences have been postponed or canceled, together with one on flu photographs in February. Some FDA workers planning the conferences are harassed and perplexed by the depletion of sources, particularly due to Makary’s public dedication to rooting out conflicts of curiosity.
This text is unique to STAT+ subscribers
Unlock this text — plus in-depth evaluation, newsletters, premium occasions, and information alerts.
Have already got an account? Log in
To learn the remainder of this story subscribe to STAT+.
