Compounding group sues FDA for removing Lilly's weight loss drug from shortage list

[noteablequotable]

Oct 7 (Reuters) - A drug compounding industry group on Monday sued the U.S. Food and Drug Administration over its decision to take Eli Lilly’s (LLY.N), opens new tab blockbuster weight loss and diabetes drugs off its list of medicines in short supply last week.
Shortages of drugs such as Lilly's Mounjaro and Novo Nordisk's (NOVOb.CO), opens new tab Ozempic have fueled demand for compounding facilities' own versions of the medicines.

In a lawsuit in Fort Worth, Texas federal court, the Outsourcing Facilities Association claims the FDA removed Lilly's tirzepatide from the list even though it remains in short supply. Lilly sells the drug under the brand names Zepbound for weight loss and Mounjaro for diabetes.

The FDA did not give the public a chance to weigh in on its decision and trusted assurances from Lilly, "the company that is self-interested in monopolizing the market," that it could meet projected demand, the lawsuit said.

It called the FDA's action "arbitrary, capricious and contrary to law."
The FDA and Lilly did not immediately respond to requests for comment.
Mounjaro had been on the FDA's list of drugs in short supply since late 2022, while Zepbound was added in April.

Compounding facilities create medicines by combining, mixing or altering drug ingredients. Federal regulations allow compounded versions to be sold to meet demand if a drug is in short supply.

If there is no shortage, federal law states that compounded drugs cannot be made "regularly or in inordinate amounts."
The active ingredient in Novo Nordisk's drugs, semaglutide, remains on the shortage list.

https://www.reuters.com/legal/compounding-group-sues-fda-removing-lillys-weight-loss-drug-shortage-list-2024-10-07/

 

[SmokeySquid]

Nothing more American than suing the government for protecting one big businesses interests over the other slightly smaller big businesses interests. Personally, anything to lower the price of medicine and increase safe access for us normal people down here in realville is appreciated.

I do assume this will get stuck in the courts and at the blazing speed the court system here works, we MIGHT be able to get compounded T around the same time that the patent runs out

 

[mopo89]

Nothing more American than suing the government for protecting one big businesses interests over the other slightly smaller big businesses interests. Personally, anything to lower the price of medicine and increase safe access for us normal people down here in realville is appreciated.

I do assume this will get stuck in the courts and at the blazing speed the court system here works, we MIGHT be able to get compounded T around the same time that the patent runs out

I don’t practice in the US and am no longer a litigator so I may be wrong but… it would make sense for them to file a motion for injunctive relief (or whatever the equivalent is) which would be heard on an emergency or expedited basis. Whether it would be granted is anyone’s guess.

 

[mostlydamp]

This is like watching some crazy street fight where the unexpected keeps happening! Having gone to the Chinese market I don't care who wins anymore but it sure is entertaining. It's like the bodybuilder picked a fight with the nerd only to have the nerd rip off his shirt and he's just massive!

Seriously though are there others like me who are fine with whatever happens in this scenario? I'll still have a freezer fulla peptides.

 

[noteablequotable]

This is like watching some crazy street fight where the unexpected keeps happening! Having gone to the Chinese market I don't care who wins anymore but it sure is entertaining. It's like the bodybuilder picked a fight with the nerd only to have the nerd rip off his shirt and he's just massive!

Seriously though are there others like me who are fine with whatever happens in this scenario? I'll still have a freezer fulla peptides.

I feel kinda bad for the FDA because they're getting pressure at both ends and in this climate no one really appreciates the service they provide. Lilly is still suing them over their refusal to classify Reta as a biologic which would prevent compounders from ever getting access to it. Now compounders are suing them over their rationale for ending shortages. Lilly probably would have sued them for not ending it.

I think by the end of this we are likely to see the FDA significantly diminished which probably isn't good for us in the long run.

 

[Tawny83]

This is like watching some crazy street fight where the unexpected keeps happening! Having gone to the Chinese market I don't care who wins anymore but it sure is entertaining. It's like the bodybuilder picked a fight with the nerd only to have the nerd rip off his shirt and he's just massive!

Seriously though are there others like me who are fine with whatever happens in this scenario? I'll still have a freezer fulla peptides.

Ain’t got no worries!

 

[SmokeySquid]

Seriously though are there others like me who are fine with whatever happens in this scenario? I'll still have a freezer fulla peptides.

Yes and no. Sure this doesn't really affect me anymore but beyond my own selfishness I can see how this hurts people if cheaper access to medicine isn't secured. But beyond even that, I see no reason to think we couldn't be in this situation in the future when talking about the next big thing.

Imagine they create a drug that completely cures dementia, prevents heart attacks or completely restores hair loss and then imagine they have the precedent to ensure there are never any cheaper methods of accessing said medication. Gotta get the wins now to ensure we can have them again in the future.

 

[exploitedworkerbee]

FDA has been neutered by the Supreme Court’s overturning of Chevron, they don’t get to make these decisions anymore. They basically had to give in or face Lilly in an ugly court battle. Instead they get to face this little compounding pharmacy org in court, which honestly seems better to me if I was calling the shots at the FDA. Dismantling the administrative state is all fun and games until you discover the power vacuum gets filled by entities driven by shareholder value.

 

[noteablequotable]

FDA has been neutered by the Supreme Court’s overturning of Chevron, they don’t get to make these decisions anymore. They basically had to give in or face Lilly in an ugly court battle. Instead they get to face this little compounding pharmacy org in court, which honestly seems better to me if I was calling the shots at the FDA. Dismantling the administrative state is all fun and games until you discover the power vacuum gets filled by entities driven by shareholder value.

That's honestly why I'm concerned about this. The FDA has already been severely hampered, but if you wanted to turn the public against them so that you have cover to take further action against the agency this is pretty much the perfect case. You have the FDA siding with a wealthy megacorp that wants to limit access to critical medication so they can maximize profits on one side, and angry medically vulnerable people on the other. It's a horrible look for the FDA, but they didn't have much of a choice.

 

[AndyPanda]

That's honestly why I'm concerned about this. The FDA has already been severely hampered, but if you wanted to turn the public against them so that you have cover to take further action against the agency this is pretty much the perfect case. You have the FDA siding with a wealthy megacorp that wants to limit access to critical medication so they can maximize profits on one side, and angry medically vulnerable people on the other. It's a horrible look for the FDA, but they didn't have much of a choice.

Power moves like this will lead to more of a crackdown on our gray market.

 

[SmokeySquid]

Power moves like this will lead to more of a crackdown on our gray market.

If the majority can stay on compounded if they win this case, then I would struggle to believe that they would do more than send C&D letters to domestic based vendors and attempt to send letters to overseas vendors.

Now if millions of Americans start using gray because that is the only way to get it at a reasonable price? Yeah, I think they will start putting immense pressure on the government to stop it. My tinfoil hat theory is that they will pressure the DEA to schedule it as a controlled substance so they can start scaring the majority of users away from even attempting to get it, whether that actually makes it harder to get is another story.

 

[meowTime]

If the majority can stay on compounded if they win this case, then I would struggle to believe that they would do more than send C&D letters to domestic based vendors and attempt to send letters to overseas vendors.

Now if millions of Americans start using gray because that is the only way to get it at a reasonable price? Yeah, I think they will start putting immense pressure on the government to stop it. My tinfoil hat theory is that they will pressure the DEA to schedule it as a controlled substance so they can start scaring the majority of users away from even attempting to get it, whether that actually makes it harder to get is another story.

There's no basis to schedule GLP-1s. They cannot be abused and are not addictive.

 

[AndyPanda]

There's no basis to schedule GLP-1s. They cannot be abused and are not addictive.

They do not need to be. The government only needs to say they are.

 

[exploitedworkerbee]

There's no basis to schedule GLP-1s. They cannot be abused and are not addictive.

Tell that to my fridge full of vials and pens

 

[meowTime]

They do not need to be. The government only needs to say they are.

Scheduling has other implications that Lilly does not want.

Government isn't going to schedule the magic anti-obesity injections in a society where 70% are overweight or obese.

 

[mostlydamp]

Yes and no. Sure this doesn't really affect me anymore but beyond my own selfishness I can see how this hurts people if cheaper access to medicine isn't secured. But beyond even that, I see no reason to think we couldn't be in this situation in the future when talking about the next big thing.

Imagine they create a drug that completely cures dementia, prevents heart attacks or completely restores hair loss and then imagine they have the precedent to ensure there are never any cheaper methods of accessing said medication. Gotta get the wins now to ensure we can have them again in the future.

I actually think you are right that we may be in this situation in the future. I guess I have a more skeptical view of our future though. I'll leave behind all the silliness and colorful comparison. I have seen so very much much death and pain in the world that nobody cares about. I truly believe that corporations own our government and Healthcare system and there is nothing we can do about that. I work for a great heathcare organization and at its best it's just a shell to make money. People get hurt and it gets brushed under the rug. Employees get ground down to nothing by a horrifyingly abusive patient base that is angry and an uncaring management. Having been selfless for decades and gotten little reward, actually been bitten, clawed, screamed at, punched, and threatened regularly I have become selfish in this, yes. Do you blame me?

I hope we can get this win too, but am not hopeful that it would change anything. Doing for myself is all I can do because in the US healthcare is geared toward not helping me but taking my money.

 

[noteablequotable]

I actually think you are right that we may be in this situation in the future. I guess I have a more skeptical view of our future though. I'll leave behind all the silliness and colorful comparison. I have seen so very much much death and pain in the world that nobody cares about. I truly believe that corporations own our government and Healthcare system and there is nothing we can do about that. I work for a great heathcare organization and at its best it's just a shell to make money. People get hurt and it gets brushed under the rug. Employees get ground down to nothing by a horrifyingly abusive patient base that is angry and an uncaring management. Having been selfless for decades and gotten little reward, actually been bitten, clawed, screamed at, punched, and threatened regularly I have become selfish in this, yes. Do you blame me?

I hope we can get this win too, but am not hopeful that it would change anything. Doing for myself is all I can do because in the US healthcare is geared toward not helping me but taking my money.

That sounds like a horrible work environment. Are you still stuck there?

 

[AndyPanda]

Scheduling has other implications that Lilly does not want.

Government isn't going to schedule the magic anti-obesity injections in a society where 70% are overweight or obese.

Fingers crossed!

 

[ZakAP]

I actually think you are right that we may be in this situation in the future. I guess I have a more skeptical view of our future though. I'll leave behind all the silliness and colorful comparison. I have seen so very much much death and pain in the world that nobody cares about. I truly believe that corporations own our government and Healthcare system and there is nothing we can do about that. I work for a great heathcare organization and at its best it's just a shell to make money. People get hurt and it gets brushed under the rug. Employees get ground down to nothing by a horrifyingly abusive patient base that is angry and an uncaring management. Having been selfless for decades and gotten little reward, actually been bitten, clawed, screamed at, punched, and threatened regularly I have become selfish in this, yes. Do you blame me?

I hope we can get this win too, but am not hopeful that it would change anything. Doing for myself is all I can do because in the US healthcare is geared toward not helping me but taking my money.

I feel this so much. I am so jaded. You are not alone in thinking this AT ALL.

 

[mostlydamp]

That sounds like a horrible work environment. Are you still stuck there?

I worked in several jobs as a nurse before finding somewhere that is better, but these things still happen regularly. I visit people at home. The other night a confused patient was handed a package that turned out to have a handgun in it and his daughter managed to get it away from him before he killed himself or her or both. Or me. I still have people act horribly toward me in those other ways, just less. It's inescapable when dealing with the public in healthcare. Other healthcare people will likely chime in with similar stories, but maybe they will let their sad emojis on my post replace this becoming a long thread about the horrors of healthcare lol