8 ms·

Your usage of the term 'feedstock' here is confusing, and it seems like you're probably operating under the erroneous assumption that contract manufacturer supp

Your usage of the term 'feedstock' here is confusing, and it seems like you're probably operating under the erroneous assumption that contract manufacturer supplies commissioned by Novo Nordisk are somehow being routed to compounding pharmacies, which isn't the case. In practice, there are generic manufacturers for semaglutide, and many other peptides still protected by US patents, mostly located in China. The more reputable of these manufacturers produce these drugs at levels of purity rivaling the 'name brand'. These manufacturers export lyophilized product en masse to middlemen that operate in the grey/black-market 'research chemical' sales market, or ship to compounding pharmacies. The consumers purchasing on the grey/black market reconstitute the drug at home (which requires a trivial level of effort), and assume some extra degree of risk in terms of product purity and sterility. Consumers wanting an extra level of assurance for product quality purchase from a compounding pharmacy that ostensibly is conducting its own assessments of product purity, and following best practices for sterile reconstitution.

andrewla 2y ago
I don't think this is true. Henry's, one of the compounding pharmacies, says that they get the chemicals from legitimate licensed producers of feedstock [1]. There is a compounding loophole, but there is no loophole for patent encumbrances -- if a compounding pharmacy is violating NN's intellectual property, then can just sue them directly; they don't have to pursue the regulatory crackdown they're going for now. There are companies that do grey/black market reconstitutions, like Pivotal Peptides. But they are not compounders. The compounders are legally selling the real thing directly to customers. Do you have a specific source that indicates that any compounding pharmacy is getting its feedstock illegally from China? [1] https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/kr9ggwr/ https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/..., discovered via https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole
- cthalupa 2y ago
  Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-maker-novo-nordisk-sues-nine-spas-clinics-pharmacies-over-copycat-drugs-2024-05-30/ https://www.reuters.com/business/healthcare-pharmaceuticals/... https://www.fiercepharma.com/pharma/lilly-files-complaints-against-8-companies-making-and-selling-compounded-versions-mounjaro https://www.fiercepharma.com/pharma/lilly-files-complaints-a... Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss https://www.fda.gov/drugs/postmarket-drug-safety-information...
  - andrewla 2y ago
    Hey, thanks -- this is great stuff! I tried looking around at these links but I couldn't find the actual lawsuit itself, and I'm curious what they specifically say. There's a difference between saying that a compounding pharmacy is selling junk claiming that it is semaglutide (that is, making false claims that may reflect on NN when the substance is ineffective), vs. claims that the drug is being produced in violation of their intellectual property rights for the synthesis of the drug.
    - throwup238 2y ago
      You can just search for the the phrase "Novo Nordisk v [company name]". For example: NOVO NORDISK INC. v AESTHETIC MAISON LLC and AESTHETIC CASA LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-Aesthetic-Maison-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK INC. v MEDIOAK PHARMACY LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK A/S AND NOVO NORDISK INC. v BOF MEDICAL CENTER, INC.: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-BOF-Medical-Center-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... In the Aesthetic Maison and Medioak pharmacy cases, Novo Nordisk alleges that they're selling a product claiming to contain semaglutide without a prescription or FDA approval. In the BOF Medical case, they're claiming "trademark infringement, false advertising, and unfair competition." They're not suing for damages, just injunctive relief ordering the defendants to stop. It doesn't look like it even matters to their cases whether the products contain real semaglutide.
  - fargle 2y ago
    > Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? > Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? because $ $$$$$$$$$$$$ that's why. not safety. MONEY. while there may be some very shady sources of fake grey/black market semiglutide that should be avoided, there are also the legal "compounders" who produce white-ish/grey market semiglutide. in the later case, it's the same active ingredient. the FDA, in it's infinite infallible wisdom (and $$$$$$$ pressure from pharma) refuses to acknowledge that while there is a tiny risk that the different buffers, processing methods, delivery and non-active ingredients, etc. have "not been studied" and might not be "less effective", that these are really small risks. tiny. i feel like the FDA deliberately conflates the dangers of questionable overseas knock-offs with the legitimately pure, regulated, legal products of compounders. are these guys violating a patent or two? meh? (note: this is a tort, but is not illegal) so sue them. but is it safe? it's as safe as anything else the FDA allows. meanwhile we keep supporting a system of patents in medicine (and software) that are actively doing exactly the opposite of what the system was put in place for: stifling innovation instead of encouraging it. padding the rich cats pockets instead of giving the small guys a chance.
- sithadmin 2y ago
  You're massively misunderstanding that Reddit post, and it doesn't help that the 'HenryMedsInfo' account is misconstruing how the pharma manufacturing supply chain works. For one, the FDA does not 'license' any manufacturer, period. They do enforce safety and quality standards, but this is not controlled through some sort of a general license, and operates on a per-facility basis. DMF listing (which isn't a 'license') does not necessarily have any relation to whether that manufacturer is supplying a brand name provider. The 'license' that account is posting about a complete fiction. There is not a license granted here in any government context, nor a license between NN and the manufacturers the post discusses. > The compounders are legally selling the real thing directly to customers. This is debatable. They are not selling 'OEM' NN product to consumers. Also - stop talking about 'feedstock'. It's weird. It's not standard industry lingo and obscures whatever the hell it is you're talking about (precursors? lyophilized product? something else?)
  - andrewla 2y ago
    I'll stop saying feedstock -- I thought I saw that in the astralcodexten article but I am mistaken. When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow. The reddit post was the closest thing I've seen to an answer to the question "where are they getting it". So if they are not getting it from producers under license from NN, where are they getting it? Why isn't the legality of that path under active legal attack? There must be some fig leaf at least that they can use to say how they got the substance when the patent is still in force, otherwise judges would immediately shut them down with an injunction.
    - sithadmin 2y ago
      >When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow >So if they are not getting it from producers under license from NN, where are they getting it? They're obtaining it from pharma labs with the right equipment and talent to produce it. The synthesis process is well understood, it's not like it's a Novo Nordisk secret. > Why isn't the legality of that path under active legal attack? It is.
    - 2y ago

andrewla 2y ago

I don't think this is true. Henry's, one of the compounding pharmacies, says that they get the chemicals from legitimate licensed producers of feedstock [1]. There is a compounding loophole, but there is no loophole for patent encumbrances -- if a compounding pharmacy is violating NN's intellectual property, then can just sue them directly; they don't have to pursue the regulatory crackdown they're going for now. There are companies that do grey/black market reconstitutions, like Pivotal Peptides. But they are not compounders. The compounders are legally selling the real thing directly to customers. Do you have a specific source that indicates that any compounding pharmacy is getting its feedstock illegally from China? [1] https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/kr9ggwr/ https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/..., discovered via https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole

cthalupa 2y ago
Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-maker-novo-nordisk-sues-nine-spas-clinics-pharmacies-over-copycat-drugs-2024-05-30/ https://www.reuters.com/business/healthcare-pharmaceuticals/... https://www.fiercepharma.com/pharma/lilly-files-complaints-against-8-companies-making-and-selling-compounded-versions-mounjaro https://www.fiercepharma.com/pharma/lilly-files-complaints-a... Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss https://www.fda.gov/drugs/postmarket-drug-safety-information...
- andrewla 2y ago
  Hey, thanks -- this is great stuff! I tried looking around at these links but I couldn't find the actual lawsuit itself, and I'm curious what they specifically say. There's a difference between saying that a compounding pharmacy is selling junk claiming that it is semaglutide (that is, making false claims that may reflect on NN when the substance is ineffective), vs. claims that the drug is being produced in violation of their intellectual property rights for the synthesis of the drug.
  - throwup238 2y ago
    You can just search for the the phrase "Novo Nordisk v [company name]". For example: NOVO NORDISK INC. v AESTHETIC MAISON LLC and AESTHETIC CASA LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-Aesthetic-Maison-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK INC. v MEDIOAK PHARMACY LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK A/S AND NOVO NORDISK INC. v BOF MEDICAL CENTER, INC.: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-BOF-Medical-Center-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... In the Aesthetic Maison and Medioak pharmacy cases, Novo Nordisk alleges that they're selling a product claiming to contain semaglutide without a prescription or FDA approval. In the BOF Medical case, they're claiming "trademark infringement, false advertising, and unfair competition." They're not suing for damages, just injunctive relief ordering the defendants to stop. It doesn't look like it even matters to their cases whether the products contain real semaglutide.
- fargle 2y ago
  > Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? > Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? because $ $$$$$$$$$$$$ that's why. not safety. MONEY. while there may be some very shady sources of fake grey/black market semiglutide that should be avoided, there are also the legal "compounders" who produce white-ish/grey market semiglutide. in the later case, it's the same active ingredient. the FDA, in it's infinite infallible wisdom (and $$$$$$$ pressure from pharma) refuses to acknowledge that while there is a tiny risk that the different buffers, processing methods, delivery and non-active ingredients, etc. have "not been studied" and might not be "less effective", that these are really small risks. tiny. i feel like the FDA deliberately conflates the dangers of questionable overseas knock-offs with the legitimately pure, regulated, legal products of compounders. are these guys violating a patent or two? meh? (note: this is a tort, but is not illegal) so sue them. but is it safe? it's as safe as anything else the FDA allows. meanwhile we keep supporting a system of patents in medicine (and software) that are actively doing exactly the opposite of what the system was put in place for: stifling innovation instead of encouraging it. padding the rich cats pockets instead of giving the small guys a chance.
sithadmin 2y ago
You're massively misunderstanding that Reddit post, and it doesn't help that the 'HenryMedsInfo' account is misconstruing how the pharma manufacturing supply chain works. For one, the FDA does not 'license' any manufacturer, period. They do enforce safety and quality standards, but this is not controlled through some sort of a general license, and operates on a per-facility basis. DMF listing (which isn't a 'license') does not necessarily have any relation to whether that manufacturer is supplying a brand name provider. The 'license' that account is posting about a complete fiction. There is not a license granted here in any government context, nor a license between NN and the manufacturers the post discusses. > The compounders are legally selling the real thing directly to customers. This is debatable. They are not selling 'OEM' NN product to consumers. Also - stop talking about 'feedstock'. It's weird. It's not standard industry lingo and obscures whatever the hell it is you're talking about (precursors? lyophilized product? something else?)
- andrewla 2y ago
  I'll stop saying feedstock -- I thought I saw that in the astralcodexten article but I am mistaken. When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow. The reddit post was the closest thing I've seen to an answer to the question "where are they getting it". So if they are not getting it from producers under license from NN, where are they getting it? Why isn't the legality of that path under active legal attack? There must be some fig leaf at least that they can use to say how they got the substance when the patent is still in force, otherwise judges would immediately shut them down with an injunction.
  - sithadmin 2y ago
    >When I say "the real thing" I mean that they are selling semaglutide, which they are obtaining somehow >So if they are not getting it from producers under license from NN, where are they getting it? They're obtaining it from pharma labs with the right equipment and talent to produce it. The synthesis process is well understood, it's not like it's a Novo Nordisk secret. > Why isn't the legality of that path under active legal attack? It is.
  - 2y ago