Eli Lilly's Newest Tactic

[Danger1212]

HereKittyKitty said:


How boring am I? I panic bought paper towels and heated bidets.

Click to expand...

Looking back, the bidet and the water pick I grabbed from Costco were probably my smartest panic purchases!

 

[Jerrey]

chmuse said:


Rice and beans and canned foods and bird pellets Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

Click to expand...

It got to the point where thieves regularly broke into highway rest areas just to take their supply of toilet paper.

 

[tubby]

On this particular matter, I'm actually pulling for Lilly to come out on top. Here's my reasoning:

Should they fail to secure that classification, their goal of halting compounding pharmacies from distributing their medication remains, and they won't back off until it's achieved. The outcome would be fresh legislation permitting compounding pharmacies to continue "producing" their formulations, yet restricting API sourcing exclusively to the manufacturer at full retail cost, and in all likelihood eliminating whatever other peptide exceptions currently benefit us.

If that path also fails, their next move would be designing future GLP offerings with far more intricate molecular structures (ones gray market labs would find difficult to replicate correctly) so they qualify for biologics status.

I "hate" pharma just as much as anyone, but hoping they can't defend their patents shows a lack of foresight.

 

[Ragnar]

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

 

[tncc_rn]

Thistley said:

From what I gather, when the FDA declares that a spider must have 8 legs to qualify (i.e., a biologic), and you turn up with a creature that has 7 legs—fine, no problem, but it simply isn't an 8-legged spider.

It's all about stretching out the patent exclusivity. You have to give them credit for their 7-legged creation; I own one myself, purchased from China, and he's incredibly adorable.

The Comprehensive Methamphetamine Control Act of 1996

Best of luck relying on "analogs". The DEA shut that route down many years back....

Don't ask how I know....

 

[tncc_rn]

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

Perhaps this is the sole factor standing between peptides and a move to Biologics status. Still, never underestimate the government's willingness to "revise" legislation when Big Pharma offers sufficient financial incentive.....

 

[homebrew]

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

The statutory text does not mention 40 amino acids. That cutoff came about via guidance rather than through formal rulemaking. Lilly tallies it as 41 amino acids (39 plus 2 additional chains). The FDA counted it as 40 amino acids, allowing 1 chain but not both, and did so without the required case-by-case analysis. The judge found the FDA's classification "arbitrary and capricious" and remanded it for re-assessment.

 

[HereKittyKitty]

chmuse said:


Rice and beans and canned foods and bird pellets Then my job got classified as essential anyway. I had customers tipping me in rolls of toilet paper and a bunch of us stole the gigantic rolls from the store restrooms.

Click to expand...

What you're describing is rationing—not theft.

 

[tncc_rn]

homebrew said:

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

The statutory text does not mention 40 amino acids. That cutoff came about via guidance rather than through formal rulemaking. Lilly tallies it as 41 amino acids (39 plus 2 additional chains). The FDA counted it as 40 amino acids, allowing 1 chain but not both, and did so without the required case-by-case analysis. The judge found the FDA's classification "arbitrary and capricious" and remanded it for re-assessment.

Yikes....guidance. Try asking any gun owner about those ATF "guidance" letters that come out of the Tech Branch. Following "the rules" turns into a total nightmare....

 

[Ragnar]

homebrew said:

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

The statutory text does not mention 40 amino acids. That cutoff came about via guidance rather than through formal rulemaking. Lilly tallies it as 41 amino acids (39 plus 2 additional chains). The FDA counted it as 40 amino acids, allowing 1 chain but not both, and did so without the required case-by-case analysis. The judge found the FDA's classification "arbitrary and capricious" and remanded it for re-assessment.

https://www.wsgr.com/en/insights/fda-releases-final-guidance-transition-of-previously-approved-drugs-to-being-deemed-licensed-biologics.html


What I take away comes from the Biologics Price Competition and Innovation Act (BPCIA) of 2009 plus the Further Consolidated Appropriations Act, 2020, both covered in the article linked above. Below is a straight excerpt that shaped how I read it.

Has the determination of which proteins can qualify as biologics changed?

Yes. Under the BPCIA, a biologic (biologic product) was defined to encompass a "protein (except any chemically synthesized polypeptide) …" In addition, an earlier FDA final guidance spelled out that a protein means "any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size." So at the outset, two conditions applied for a protein to count as a biologic: 1) it had to exceed 40 amino acids in size; and 2) it could not be chemically synthesized. With the Further Consolidated Appropriations Act, 2020, the chemically synthesized exclusion is gone, which could raise the count of proteins eligible to become biologics.

Maybe something is slipping past me in all the legal language, but my reading is that under this definition retatrutide does not exceed 40 amino acids, no matter how Lily frames it or what a judge decides.

 

[HereKittyKitty]

NBA_MiddleAgedGirl said:

byefatlicia said:

birdwhacker said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

Stocking up is generally wise, though it probably won't make much of a difference for gray.

Acting like Gray peps aren't already scribbled on BP dry erase boards would be foolish. Look at what happened in September: CN manufacturing sites were closed and 2 of the largest vendors went down. Customs seizures and shipping problems keep climbing. Crypto access is getting squeezed by banks. My tinfoil hat is starting to buzz.

No doubt about it. While RFK Jr. was in front of Congress for his hearings, he brought up "inspecting" warehouses in China (framed as safety checks). Things are about to get interesting.

He's just trying to line up a side hustle for the day he gets fired. Total grifter.

 

[HereKittyKitty]

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

Discussion is already underway about a PUO classification and eliminating RUO.

 

[BNLFL]

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

I'm already doing it, and I won't stop. My trust in them isn't there. They're nearly as influential as oil giants—maybe even more so. Just look at that China kung fu nonsense. That's simply how I see it. Nothing here is going to waste.

Danger1212 said:

Stockpiling peptides brings back memories of the COVID era, when everyone rushed to grab ammo, primers, powder, and anything else that came to mind.

It was the best of times, it was the worst of times…

So, have you built up your supply yet?

 

[Ragnar]

1-/q

HereKittyKitty said:

Ragnar said:

Under the standard classification rules, retatrutide counts as a synthetic peptide built from 39 amino acids. Given that the existing statute sets the Biologics threshold at 40 amino acids, this looks like an open-and-shut situation where the courts ought to toss out Lilys argument. That said, courts do not always adhere to statutes the way they are drafted, so it would not shock me if Lily manages to persuade a judge to read the requirement as 40 amino acids.

When it comes to a broader sweep against gray market peptides, my guess is that AI keeps factoring into the picture. Another route that would actually matter is rewriting laws so peptides cannot be sold to ordinary individuals under the "research use only" label. I am hoping that never comes to pass, but that worry has me thinking about bumping up my 2 year supply.

Discussion is already underway about a PUO classification and eliminating RUO.

This is news to me, though it does sound intriguing. I get that ruo stands for research use only. But what does puo mean?

 

[NBA_MiddleAgedGirl]

HereKittyKitty said:

NBA_MiddleAgedGirl said:

byefatlicia said:

birdwhacker said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

Stocking up is generally wise, though it probably won't make much of a difference for gray.

Acting like Gray peps aren't already scribbled on BP dry erase boards would be foolish. Look at what happened in September: CN manufacturing sites were closed and 2 of the largest vendors went down. Customs seizures and shipping problems keep climbing. Crypto access is getting squeezed by banks. My tinfoil hat is starting to buzz.

No doubt about it. While RFK Jr. was in front of Congress for his hearings, he brought up "inspecting" warehouses in China (framed as safety checks). Things are about to get interesting.

He's just trying to line up a side hustle for the day he gets fired. Total grifter.

Couldn't agree more! With any luck, his name is among those getting the axe shortly. My sense is that he's on his way out.

 

[Danger1212]

BNLFL said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

I'm already doing it, and I won't stop. My trust in them isn't there. They're nearly as influential as oil giants—maybe even more so. Just look at that China kung fu nonsense. That's simply how I see it. Nothing here is going to waste.

Danger1212 said:

Stockpiling peptides brings back memories of the COVID era, when everyone rushed to grab ammo, primers, powder, and anything else that came to mind.

It was the best of times, it was the worst of times…

So, have you built up your supply yet?

Yep, I've done that, plus I've got a few GBs sitting on ice — one of which you had to keep quiet about thanks to my banner status

No clue what I'll do with R140 on my own, though I've got 10 years to figure that out

 

[deluge]

Danger1212 said:


I think my best panic buy was that bidet and the water pick from Costco!

Click to expand...

You're not running those two together, are you? Like, simultaneously?

 

[BNLFL]

Danger1212 said:

BNLFL said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

I'm already doing it, and I won't stop. My trust in them isn't there. They're nearly as influential as oil giants—maybe even more so. Just look at that China kung fu nonsense. That's simply how I see it. Nothing here is going to waste.

Danger1212 said:

Stockpiling peptides brings back memories of the COVID era, when everyone rushed to grab ammo, primers, powder, and anything else that came to mind.

It was the best of times, it was the worst of times…

So, have you built up your supply yet?

Yep, I've done that, plus I've got a few GBs sitting on ice — one of which you had to keep quiet about thanks to my banner status

No clue what I'll do with R140 on my own, though I've got 10 years to figure that out

I'm fairly sure I've got my plan sorted, and I might mix up and go through a whole vial just for fun. I'm still a bit away from hitting my target, though I keep dropping it because of the fat around my midsection and flanks.

 

[Danger1212]

BNLFL said:

Danger1212 said:

BNLFL said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

I'm already doing it, and I won't stop. My trust in them isn't there. They're nearly as influential as oil giants—maybe even more so. Just look at that China kung fu nonsense. That's simply how I see it. Nothing here is going to waste.

Danger1212 said:

Stockpiling peptides brings back memories of the COVID era, when everyone rushed to grab ammo, primers, powder, and anything else that came to mind.

It was the best of times, it was the worst of times…

So, have you built up your supply yet?

Yep, I've done that, plus I've got a few GBs sitting on ice — one of which you had to keep quiet about thanks to my banner status

No clue what I'll do with R140 on my own, though I've got 10 years to figure that out

I'm fairly sure I've got my plan sorted, and I might mix up and go through a whole vial just for fun. I'm still a bit away from hitting my target, though I keep dropping it because of the fat around my midsection and flanks.

Come on, share what you're thinking!

I can already picture the post I'll be writing 1 month from now, once I've reconstituted my R140:

Need Help - RS on 14mg of Reta and Hungry

 

[MikeyMike]

NBA_MiddleAgedGirl said:

byefatlicia said:

birdwhacker said:

CMA Pooky said:

Seeing this, I feel like stocking up on as many kits as my budget allows. Big pharma's greed knows no bounds.

Stocking up is generally wise, though it probably won't make much of a difference for gray.

Acting like Gray peps aren't already scribbled on BP dry erase boards would be foolish. Look at what happened in September: CN manufacturing sites were closed and 2 of the largest vendors went down. Customs seizures and shipping problems keep climbing. Crypto access is getting squeezed by banks. My tinfoil hat is starting to buzz.

No doubt about it. While RFK Jr. was in front of Congress for his hearings, he brought up "inspecting" warehouses in China (framed as safety checks). Things are about to get interesting.

China permitting inspections is something I just can't picture.