medicine

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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So shortage being over mean substitutes aren’t allowed which is what these compounders were? Is my understanding right?

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Dr Omar can correct me but substitutes might be wrong word. It’s more similar to like….a generic. It’s the same compounds — not substitutes — but made in violation of the patent at the compounder

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Sorry. I wrote another cast about air traffic controllers and didn’t realize what you replied to. 😂 

Okay, so the patented GLP-1s were officially on shortage. This made the compounding legal to do. Now they are off shortage, and so the compounding becomes illegal again. The shortage is over because (supposedly) there is enough of the patented med to meet demand (I doubt this)