Sema compounding issues?

philly_gal82

philly_gal82

Active member
Has anyone else heard they are trying to stop sema from being compounded? Sounds like they're trying a new approach, but same goal. Ozempic alternatives are at risk.
 
If successful, they'll get the FDA to classify it as too complex to compound, blocking all compounding. Takes a year or so, so not immediate.

Also, I saw that Lilly is aiming to get Retatrutide labeled as a biological from the start, preventing compounding when it's released in '26.

It's all about the money, which is the nature of the pharmaceutical business.
 
It doesn't seem complex to compound to me. Classifying Reta as a biologic seems like a stretch. Biologics are derived from living cells, not freeze-dried in a lab.
 
If one part of CagriSema gets classified as demonstrably complex, it'd probably make it easier to argue the same for future products.

They'll use every trick to keep us paying top dollar. I wonder how far they'll go to block gray market options if enough people switch 🤔
 
Exactly! It's been pretty simple to compound for a couple of years now, with no issues as long as pharmacies follow proper guidelines.

And I doubt the FDA will call Reta a biologic. They already refused, and Lilly sued. The FDA seems firm.
 
Maybe they'll crack down harder on imports here. A friend doing research is willing to wait longer now to have stuff sent to a US warehouse first.
 
It's sad when you think about how many people it could help, and diseases it could prevent, especially since it's so cheap to produce. They just don't care about us at all.
 
Yeah. Imagine if Jonas Salk hoarded the polio vaccine for profit!

It's a disgrace.

I think the government should just seize the patent and pay them a fair price, then let everyone have cheap access via generics.

It'd save money immediately and long-term.
 
I want to agree, but that would set a bad example for medical innovation. Most major research happens here because of potential profits.

A good middle ground would be the government negotiating a reasonable price based on the entire population. But that's unlikely since we need to fix insurance first 🙃
 
Either way, the threat of eminent domain could help.

The point is, withholding these drugs is killing people.

Even if you don't care about people, it's costing billions in healthcare.
 
No, that's not how the Chevron thing works.

Statutes are laws passed by Congress; regulations are agency rules.

Chevron deference was about courts deferring to agency interpretation of statutes. Overruling it means courts interpret statutes again.

Auer deference, where courts defer to agencies on their own regulations, still stands.
 
I heard there are only a few raw peptide manufacturers in China.

Could China crack down on them? Could Lilly or Novo make a deal with China? It'd pressure gray market companies that just process the peps.

Never underestimate greed.
 
Companies in India could fill the gap if that happens.

China probably doesn't care what an American company wants, especially with how little they've done to stop certain things from getting into the country. But sadly, there's probably more money in stopping Americans from getting gray market drugs.
 
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