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Omar pfp
Omar
@dromar.eth
Big news today: GLP-1 shortage is over. This will have big implications for compounding pharmacies, patients but much much more Essentially, FDA declared not that Ozempic/Wegovy (semaglutide) shortage resolved, meaning compounded GLP-1s are no longer allowed, tanked HIMS stock. For perspective, ~25% of GLP-1s are compounded, serving millions of patients. And a big source of revenue for compounders that have shifted biz models, but even more so developed these into robust treatments (ex: B12/sema combo) Compounders are now challenging in court to continue production, tirzepatide is already in court, semaglutide cases likely will join in. During this time, while the current lawsuit ongoing, FDA is maintaining its enforcement discretion. Now here is where this turns another corner:
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Omar pfp
Omar
@dromar.eth
The new administration. FDA nominee Marty Makary is CMO of Sesame a telehealth co. offering compounded GLP-1s. And with the recent ruling on federal agencies restriction of power and Trump admin overall adverse to any regulation. We coul see a potential shift in FDA approach to compounding & drug access This battle may set precedent for FDA regulation but how we regulate medications.
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Syed Shah🏴‍☠️🌊 pfp
Syed Shah🏴‍☠️🌊
@syed
So shortage being over mean substitutes aren’t allowed which is what these compounders were? Is my understanding right?
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dthinks
@dthinks
Generics of drugs are generally allowed; however, they typically have to wait a certain amount of time before they can be produced.
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