Sema removed from Compounding?

[jennster]

I'm not sure if anyone has seen this yet, but now they are trying to get sema removed from compounding. They're taking a different angle with the same intentions. Ozempic compounding

 

[touringsedan]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

 

[Lilith]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

And yet, it is so very obviously not complex to compound. If the FDA allows the classification of Reta as a biologic, it seems they are full of it. From what I read, biological have to be derived from living cells and tissues and can’t by lyophilized in a lab, which we already know is absolutely possible.

 

[SmokeySquid]

Trying to have FDA label it is as demonstrably complex to compound would prevent all compounding. This process usually takes 12-18 months, so not anytime soon.
Glad we have research peps!

On another note, Eli Lilly is thinking ahead with Retatrutide and already filed to have it labeled as a biological, this would also prevent compounding out of the gate when it goes retail in 2026.

It's all about making all the profits. But that is why they are in the drug business.

I assume having one component of CagriSema already on the demonstrably complex to compound list, should they succeed in getting it classified as such, would make it much easier to argue the same for future products that they release.

Expect to see every trick in the book pulled out in an attempt to keep this cash cow, aka the American people, paying full price for all of their current and future products. Makes me wonder what lengths they will go to prevent people from using gray market products if enough people move over to them

 

[YoYoFat]

And yet, it is so very obviously not complex to compound. If the FDA allows the classification of Reta as a biologic, it seems they are full of it. From what I read, biological have to be derived from living cells and tissues and can’t by lyophilized in a lab, which we already know is absolutely possible.

Exactly! It’s been so easy to compound it’s been done for over two years without any issue, at least not with respect to the pharmacies following USP guidelines.

And I don’t see FDA classifying Reta as a biologic. They already rejected that request, and EL sued HHS (FDA’s parent agency) over it, and FDA is holding firm.

 

[scarywood75]

I assume having one component of CagriSema already on the demonstrably complex to compound list, should they succeed in getting it classified as such, would make it much easier to argue the same for future products that they release.

Expect to see every trick in the book pulled out in an attempt to keep this cash cow, aka the American people, paying full price for all of their current and future products. Makes me wonder what lengths they will go to prevent people from using gray market products if enough people move over to them

I doubt there's anything realistically they can do to stop China

 

[jennster]

I doubt there's anything realistically they can do to stop China

I think they could place additional scrutiny on our end on stuff being imported in. At this point the researcher is glad to wait the extra time and have things sent to a US warehouse and then routed to them.

 

[onepotatotwopotato]

It's sad really when you think how many people it could help, and illnesses it could prevent, and even worse how cheap it is to make, that they won't make it readily available.. They really don't care about us at all lol

 

[Glp1judd]

It's sad really when you think how many people it could help, and illnesses it could prevent, and even worse how cheap it is to make, that they won't make it readily available.. They really don't care about us at all lol

Yep. Imagine if Jonas Salk gate kept the polio vaccine for profit!

This is shameful.

I honestly think the govt should seize the patent under eminent domain (which includes paying fair price for it) and let the ppl have cheap access via generics.

Would save money day one vs the other medical issues currently treating and long term it’s a no brainer.

 

[CallieKat]

I agree. Governments around the world should pay off the pharma guys and save lives with cheap generics.

 

[SmokeySquid]

Yep. Imagine if Jonas Salk gate kept the polio vaccine for profit!

This is shameful.

I honestly think the govt should seize the patent under eminent domain (which includes paying fair price for it) and let the ppl have cheap access via generics.

Would save money day one vs the other medical issues currently treating and long term it’s a no brainer.

As much as I want to agree because F big pharma, that would set a horrible precedent for innovation in this country. Most of the groundbreaking medical research is done here for a multitude of reasons, key among them is the promise of return on investment (profit) .

A good compromise IMO would be for the government to work out a reasonable price and use the entire pool of potential customers, aka the population, to work out a reasonable price each year like other countries do. Unfortunately, it's more than likely another pipe dream as that would require us to fix our insurance and medical industry first

 

[Glp1judd]

Either way. Threat of eminent domain might help.

Point is, gate keeping these drugs is actually killing people.

And even if you don’t care about ppl, it’s costing billions in unnecessary health costs.

 

[noteablequotable]

And yet, it is so very obviously not complex to compound. If the FDA allows the classification of Reta as a biologic, it seems they are full of it. From what I read, biological have to be derived from living cells and tissues and can’t by lyophilized in a lab, which we already know is absolutely possible.

The FDA isn't going to allow anything, they already told Lilly no and Lilly is suing over it.

 

[touringsedan]

The FDA isn't going to allow anything, they already told Lilly no and Lilly is suing over it.

It could get interesting as the Supreme Court ruling on Chevron will now allow the drug companies to sue and challenge FDA rulings and have a judge decide who is interpreting the ruling correct.

 

[YoYoFat]

I agree. Governments around the world should pay off the pharma guys and save lives with cheap generics.

Elon could do it singlehandedly, but he won't.

 

[YoYoFat]

It could get interesting as the Supreme Court ruling on Chevron will now allow the drug companies to sue and challenge FDA rulings and have a judge decide who is interpreting the ruling correct.

No, that's not the impact of the overturning of Chevron deference here.

Statutes and regulations are two different things. Statutes are passed by Congress; regulations are created by agencies.

Chevron deference was where the courts deferred to agency interpretation of statutes. The overruling of Chevron deference means that the courts will no longer defer to the agencies in their interpretation of statutes, and that the interpretation of statutes will return to the courts (where it appropriately belongs, IMO).

But Auer deference remains. Auer deference is the deference the courts must give to agencies, including FDA, in the interpretation of their own agency regulations.

Courts get to interpret statutes (the overruling of Chevron deference), but agencies still get deference in how they interpret their own regulations.

 

[GimmeABreak]

I doubt there's anything realistically they can do to stop China

I have heard that there are only a handful of raw peptide producers in China.

Could the Chinese government crack down on the peptide producers? Could Lilly or Novo work out some kind of deal with the Chinese government to make this happen? It would likely put a lot of pressure on the gray market companies that are just lyophilizing the peps.

I never underestimate greed as a motivator.

 

[SmokeySquid]

I have heard that there are only a handful of raw peptide producers in China.

Could the Chinese government crack down on the peptide producers? Could Lilly or Novo work out some kind of deal with the Chinese government to make this happen? It would likely put a lot of pressure on the gray market companies that are just lyophilizing the peps.

I never underestimate greed as a motivator.

I imagine that companies in India will be able to fill the void should that happen.

Part of me assumes that China would not care about what an American company wants, especially considering how little has been done to stop fent from getting into the country but I also think, sadly, there is less money involved in stopping fent than there would be to stop Americans from getting gray market drugs.

 

[Glp1judd]

No, that's not the impact of the overturning of Chevron deference here.

Statutes and regulations are two different things. Statutes are passed by Congress; regulations are created by agencies.

Chevron deference was where the courts deferred to agency interpretation of statutes. The overruling of Chevron deference means that the courts will no longer defer to the agencies in their interpretation of statutes, and that the interpretation of statutes will return to the courts (where it appropriately belongs, IMO).

But Auer deference remains. Auer deference is the deference the courts must give to agencies, including FDA, in the interpretation of their own agency regulations.

Courts get to interpret statutes (the overruling of Chevron deference), but agencies still get deference in how they interpret their own regulations.

Aren’t all regulations derived at some point from statute?

 

[scarywood75]

I have heard that there are only a handful of raw peptide producers in China.

Could the Chinese government crack down on the peptide producers? Could Lilly or Novo work out some kind of deal with the Chinese government to make this happen? It would likely put a lot of pressure on the gray market companies that are just lyophilizing the peps.

I never underestimate greed as a motivator.

China never cared about US and they'll never be, also cracking on the gray market wouldn't just affect the US, it's not the only country that buys from them.