US judge bars copies of Lilly weight-loss drug

[indolent]

The 503B pharmacies clearly cannot get around compounding restrictions simply by adding something for a specific patient. The 503A pharmacies may do so. Section 503A bars them generally from compounding what is "essentially a copy of a commercially available drug product" except when done irregularly and only manufactured in small amounts.

However, the term “ 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product." Food, Drug & Cosmetic Act, sec. 503A(b)(2). The attorneys for compounding pharmacies will try to make this exception as big as possible and argue that the language of the Food Drug & Cosmetic Act makes the prescribing physician the only person that can decide. That interpretation seems to create such a big loophole that it swallows the rule: A doctor can always ask the compounding pharmacy to tweak the drug in some way. I won't venture an opinion as to what the outcome will be because (1) as far as I can tell, no one really knows right now and (2) this is far outside my area of expertise. However, if a compounding pharmacy is selling tirzepatide with some special additive that supposedly makes it work better, there is a good chance that whatever was added is an attempt to get around compounding restrictions.

AFAIK the compounding pharmacies have been adding one or another B vitamin for that very reason, even during the FDA-declared shortage.

I wonder, though, in a more truly legitimate way, what a patient's recourse is when a doctor wants her to take a dosage of something that's between the offered dosages. For example, starting tirz titration at 1mg instead of 2.5. Or knocking the dosage down a bit for a T2 diabetic who's hit intolerable side effects, but might not get adequate benefit by dropping down a full 2.5mg. I assume compounding is the only solution. So we might see a lot of 2/4/6/8/9.5 mg tirz prescriptions soon...?

 

[keangkong]

AFAIK the compounding pharmacies have been adding one or another B vitamin for that very reason, even during the FDA-declared shortage.

I wonder, though, in a more truly legitimate way, what a patient's recourse is when a doctor wants her to take a dosage of something that's between the offered dosages. For example, starting tirz titration at 1mg instead of 2.5. Or knocking the dosage down a bit for a T2 diabetic who's hit intolerable side effects, but might not get adequate benefit by dropping down a full 2.5mg. I assume compounding is the only solution. So we might see a lot of 2/4/6/8/9.5 mg tirz prescriptions soon...?

Some compounding pharmacies are already doing so.

 

[Batscout]

The 503B pharmacies clearly cannot get around compounding restrictions simply by adding something for a specific patient. The 503A pharmacies may do so. Section 503A bars them generally from compounding what is "essentially a copy of a commercially available drug product" except when done irregularly and only manufactured in small amounts.

However, the term “ 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product." Food, Drug & Cosmetic Act, sec. 503A(b)(2). The attorneys for compounding pharmacies will try to make this exception as big as possible and argue that the language of the Food Drug & Cosmetic Act makes the prescribing physician the only person that can decide. That interpretation seems to create such a big loophole that it swallows the rule: A doctor can always ask the compounding pharmacy to tweak the drug in some way. I won't venture an opinion as to what the outcome will be because (1) as far as I can tell, no one really knows right now and (2) this is far outside my area of expertise. However, if a compounding pharmacy is selling tirzepatide with some special additive that supposedly makes it work better, there is a good chance that whatever was added is an attempt to get around compounding restrictions.

The 503B pharmacies clearly cannot get around compounding restrictions simply by adding something for a specific patient. The 503A pharmacies may do so. Section 503A bars them generally from compounding what is "essentially a copy of a commercially available drug product" except when done irregularly and only manufactured in small amounts.

However, the term “ 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product." Food, Drug & Cosmetic Act, sec. 503A(b)(2). The attorneys for compounding pharmacies will try to make this exception as big as possible and argue that the language of the Food Drug & Cosmetic Act makes the prescribing physician the only person that can decide. That interpretation seems to create such a big loophole that it swallows the rule: A doctor can always ask the compounding pharmacy to tweak the drug in some way. I won't venture an opinion as to what the outcome will be because (1) as far as I can tell, no one really knows right now and (2) this is far outside my area of expertise. However, if a compounding pharmacy is selling tirzepatide with some special additive that supposedly makes it work better, there is a good chance that whatever was added is an attempt to get around compounding restrictions.

Kong, I’m a lawyer too and, while I find all of this quite interesting, I am certainly far from an expert. This all makes me ruminate. If EL and the FDA want to hold hands while skipping into the compounding patent enforcement battleground, I think many of the compounding pharmacies will have problems. It would be hard to argue that a peptide formulation is made by a pharmacy pursuant to a doctor’s prescription for a specific patient’s needs when nearly all the compounded tirzepatide for a particular telehealth provider has the same formulation: i.e. tirzepatide plus B-12 or L- carnitine, or niacinamide. If they litigated then successfully obtained patient records in discovery, it would be hard to claim a specific patient formulation when all patients are receiving the same formulation without supportive clinical documentation. I used Henry, then Mochi, back in my beginning peptide hobby and I imagine the Tirz included B12 or some other additive but there was no documented need for it.

 

[Morbius]

"Use one weird trick to keep your compounding pharmacy open! FDA regulators hate this!"

 

[keangkong]

Kong, I’m a lawyer too and, while I find all of this quite interesting, I am certainly far from an expert. This all makes me ruminate. If EL and the FDA want to hold hands while skipping into the compounding patent enforcement battleground, I think many of the compounding pharmacies will have problems. It would be hard to argue that a peptide formulation is made by a pharmacy pursuant to a doctor’s prescription for a specific patient’s needs when nearly all the compounded tirzepatide for a particular telehealth provider has the same formulation: i.e. tirzepatide plus B-12 or L- carnitine, or niacinamide. If they litigated then successfully obtained patient records in discovery, it would be hard to claim a specific patient formulation when all patients are receiving the same formulation without supportive clinical documentation. I used Henry, then Mochi, back in my beginning peptide hobby and I imagine the Tirz included B12 or some other additive but there was no documented need for it.

What you wrote make sense. I do note that the text of the US code makes the prescriber the person who determines the medical need. I wonder if Eli Lilly or the FDA can override these determinations based upon them being obvious subterfuges. Also, I wonder whether state medical boards would get involved and seek to discipline doctors. These are just thoughts. As a legal research geek, this is enormously interesting for me. I’ve tried to avoid writing about this issue much because I worry my lack of any practical experience in this field would cause me to make uninformed statements. I also wonder whether state regulatory boards, which actually conduct most 503A pharmacy regulation, would simply tell compounding pharmacies that these are subterfuges and must stop. I believe lay people overestimate the considerable power of huge corporations and underestimate the authority of state regulatory bodies, such as those that regulate pharmacies and physicians.

 

[keangkong]

"Use one weird trick to keep your compounding pharmacy open! FDA regulators hate this!"

The FDA usually doesn’t normally take enforcement actions against 503A pharmacies even though the FDA is legally empowered to do so. The FDA leave that to state regulators. If state regulators tell your pharmacy that it can’t do something, it takes an enormously brave person to defy them.

Edit: I added the word normally because I had unintentionally omitted it. I'm sure that at some point the FDA must have taken an enforcement action against 503A pharmacies because legally it has the authority to do so.

 

[Batscout]

The FDA usually doesn’t take enforcement actions against 503A pharmacies even though the FDA is legally empowered to do so. The FDA leave that to state regulators. If state regulators tell your pharmacy that it can’t do something, it takes an enormously brave person to defy them.

You are right about that.

 

[Batscout]

What you wrote make sense. I do note that the text of the US code makes the prescriber the person who determines the medical need. I wonder if Eli Lilly or the FDA can override these determinations based upon them being obvious subterfuges. Also, I wonder whether state medical boards would get involved and seek to discipline doctors. These are just thoughts. As a legal research geek, this is enormously interesting for me. I’ve tried to avoid writing about this issue much because I worry my lack of any practical experience in this field would cause me to make uninformed statements. I also wonder whether state regulatory boards, which actually conduct most 503A pharmacy regulation, would simply tell compounding pharmacies that these are subterfuges and must stop. I believe lay people overestimate the considerable power of huge corporations and underestimate the authority of state regulatory bodies, such as those that regulate pharmacies and physicians.

I don’t have much practical experience with state pharmacy regs either, although I do also have an MHA and work in healthcare. You have raised some excellent points. I will enjoy following the legal path of peptide patents.