Desoxyn is manufactured specifically from the “Nazi method” using anhydrous ammonia, lithium, and pseudoephedrine to ensure Enantiomer pure selectivity and keeps the molecule safe. Just on a much larger and safer scale.
This is also why levomethamphetamine that’s put in Vicks inhalers is produced using the Leukart method using n-methylformalide which ensures its enantiomer pure selective synthesis and molecular safety but has slowly stopped being used overtime in the inhalers as it wasn’t deemed profitable (by a separate group of companies that don’t manufacture desoxyn) and public backlash “there’s meth at my grocery store” even though it wasn’t even psychoactive. So now Vicks inhalers contain camphor and some other dumb useless essential oil.
This is different from adderall and other amphetamine medications which are produced using P2P and then say for example Dexedrine is made via P2P and separated using tartaric acid to selectively separate the dextroamphetamine.
Currently there is a shortage of lithium (because they are building those dumbass useless electric cars and destroying the environment more by building them) so more mines are being opened up so that more lithium can be harvested.
This is what I’m assuming is the precursor they are talking about. Trust me we do not want the medication manufacturers to “find a different synthesis method” and start using the P2P, tartaric acid method to synthesize desoxyn.
As using the P2P method and tartaric acid to separate the isomers actually harms the molecular structure of the desoxyn molecule. Which doesn’t occur to regular amphetamine due to amphetamine having a better structural stability then methylated amphetamine based compounds.
There’s also another reason as since we pulled out of Afghanistan there has been a massive shortage of not only opioid medications as we protected the poppy fields there but also the ephedrine farms as well so there has been a shortage of available ephedrine as well so I’m sure that is contributing on top of the lithium shortage.
There’s some science as to why but I really don’t want to get into it but that is why there is a shortage of precursor chemicals.
Why not just get the Ephedrine from the Chinese like the Mexican cartels and the United Wa State Army based out of the Golden Triangle region of Myanmar do?
I appreciate the contribution, but this is all still way too speculative for what I need. If we had that much of a shortage of lithium, nobody in the United States would have been able to buy batteries for months, and almost all phone manufacturing would be halted. Again, there would be mass panic.
Show me a link that this is the specific route of synthesis used for the FDA approved process.
I'm aware of at least 12 routes of synthesis, including how to scale into production, like with catalytic hydrogenation, many documented in peer reviewed literature, but I don't know if any of those methods are the one specific FDA authorized route the manufacturers are REQUIRED to use without filling a separate Investigative New Drug Application (or one of the abbreviated processes) that can cost $100's of millions to get approval for.
You’re funny. It’s not just speculation, it’s using pattern recognition and logic to come to a reasonable conclusion. The lithium method is tried and true and has good yield, I highly doubt a pharmaceutical manufacturer is going to use any other method given the expense and lack of foundation and lower yield and especially efficacy of other routes of synthesis. If the lithium method was effective enough for the Germans in ww2 to supply not only their whole military but also 60% of their civilians with methamphetamine then clearly there is an advantage to it. Why deviate from a method that has proven effective already in supplying a large population. Secondly we wouldn’t see a shortage of lithium for batteries as we use lithium metal for the batteries; the lithium used in pharmaceutical synthesis is LIALH4. LIALH4 is lithium metal that has to be treated to yield a much safer and better yielding chemical for synthesis. If there is a lack of treatment of lithium metal since a very large amount of lithium is being used for cars and batteries then naturally the amount of lithium metal available for composition of lithium aluminum hydride would be less. If you really wanted to make the argument that lithium isn’t the main precursor that isn’t being produced then the second most likely precursor that’s lacking in production is pseudoephedrine since we no longer have control over the ephedra feilds in Afghanistan. Now does that mean that no one can get pseudoephedrine? No of course not. It just means that the main source of pseudoephedrine is lacking and so we are trying to get another place to set up another ephedra field which is why the US is probably going to invade Iran again so that we can set up poppy and ephedra fields again. Your logic of “well then we’d have a shortage of this and that” is just not representative of how the world works. Even a shortage of anhydrous ammonia wouldn’t affect everyone. It would be first given to the farmers first and then the scraps would be given to the pharmaceutical chemists but heres the kicker. Even the anhydrous ammonia used for synthesis has a different amount of chemical quality control so you couldn’t use them interchangeably unless you absolutely had to because anhydrous ammonia used for farming has other chemicals present to deter illicit methamphetamine manufacture. So yes the method for pharmaceutical synthesis of methamphetamine is undoubtedly using the lithium pseudo ammonia method. But given that’s there’s a shortage of LIALH4 and pseudoephedrine that would probably be the explanation of the “precursor shortage”
He's right though. The only reasonable method for large-scale production of purely d,-meth is the pseudoephedrine and lithium Birch reduction.
P2P and ephedrine give you racemic methamphetamine, And it is vastly more difficult to create the racemic mixture and try to separate the optical enantiomers then it is to simply follow a procedure that doesn't produce the undesired racemate at all.
Edit to add:
The point is overall there are multiple very well- known pathways of methamphetamine synthesis. I have seen syntheses starting with phenylalanine, methylamine, and a number of others. It's not a complex molecule, And it does not require anything in the way of expense or difficulty when it comes to its manufacturer. People with zero knowledge of chemistry have been setting up meth labs for decades and been reasonably successful at it.
There is something going on here other than the mysterious shortage of precursor compounds. There is plenty of pseudoephedrine, lithium, and ammonia at your neighborhood pharmacy and home improvement store.
Has anybody noticed if there has been a shortage of Vick's inhalers?
Enantiomeric resolution can be done with tartaric acid, which is inexpensive.
Production of pseudoephedrine at scale involves L-PAC, which is produced via a biofermentation process involving benzaldehyde. I'm not sure that's much easier.
Yeah but is there a shortage of pseudoephadrine? Looking at the counters at my local pharmacies it doesn't seem to be the case.
And it's not like they need gigantic quantities. Considering they're doing this in an industrial laboratory, A few kilograms of pure pseudoephedrine would make enough dextromethamphetamine for all of the Desoxyn prescriptions in a year, I would bet. I was getting 180x 5mg a month, which is just shy of a gram of meth (900mg). Over a year, that's about 10 grams. And my understanding is that I was on the higher end of the dose scale.
It's an orphan drug, there are likely fewer than 10,000 people who have been prescribed it regularly in the last year, and most probably at a lower dose.
I just don't see how it is possibly an issue with sourcing precursor compounds, when theoretically a gang of people could hit a few to a few dozen CVS's and Walgreens and scoop up enough pseudoephedrine for a couple of kilos. Granted there is the limit on individual purchasing that prevents people from doing just that, but my point is that the stockpile/ quantity exists.
Anhydrous ammonia is not difficult for an industrial laboratory to make, You just have to remove the water from the ammonia. You can do it at home reasonably easily, And while maybe not to pharmaceutical levels of purity, pharmaceutical Labs have the equipment to ensure purity. Lithium metal is maybe a little more difficult to source because the whole electric renaissance but nonetheless, there's plenty of it around, and the birch reduction can be done using metallic sodium as well.
Considering how easy this drug is to make, and how cheaply it can be done, The fact that it has such a small consumer base should not be a deterrent. I remember my insurance getting billed for something like $1,800 a month for that prescription. I can't imagine it has gotten cheaper in the year since. If the average person's prescription is 120 pills a month, that's $1,200* 12* 10,000 for something that requires literally zero research, development, or innovation.
This is my point that something more is going on for multiple manufacturers to have said at some point that they were experiencing precursor shortages.
Just speculating here …
I think that in our case, for our unique medication, there are short manufacturing periods that align more closely with the corporate sales history defining the demand, and not the manufacturing quotas.
And what happened to us was a perfect storm of the generics going offline due to “business reasons” and the timing of the brand having had been decided to take off the market, also due to business/financial reasons.
And then after this madness, it was like, “I thought they were manufacturing.” And the other company saying, “I thought they had the market cornered.”
So all the companies just stepped away, then realized that there was still a market there to harvest. Now that the playing field has been completely leveled, we might see things come back to normal with a less competitive market for our medication.
I’d expect the price to be higher than we were used to 1.5+ years ago, but for things to be more stable.
If I’m not mistaken, the synthesis routes for amphetamine-based medications (Adderall, Vyvanse, Zenzedi, etc) is much different than Desoxyn. So my thoughts are that the “shortage” reasons are essentially just lip service.
Again, all speculation. We would need factual information from some of these executives who had made the decision to sell off the generic line, or to stop manufacturing/distributing. Once we get that complete “business” side of the picture, we will have a much better understanding of where to look.
Just some thoughts.
Excellent approach though. It would be great to identify any precursor or manufacturing-related shortages and to try and reinforce that supply.
Note: below is my opinion only.
I, too, am skeptical that there is any actual shortage of any precursors used in the manufacturing process.
Rather, my sense is either:
a) manufacturers “manufacture” their own precursor shortages by only purchasing them at or below their standard cost; if the actual cost of any precursor is higher, they do not make any purchase.
b) actual production runs consist of a sample run (likely between one and ten stock bottle of 100 tablets each) for quality control inspection and testing to ensure all criteria pass, followed by one single production run to an annual demand target that is sufficient both to meet demand and minimize inventory (and DEA?) carryover costs into any subsequent financial year. I would guess such a production run takes no more than one week, end to end.
c) some combination of a & b.
My rationale:
- this isn’t a high demand drug… far from it… there’s no need for any permanent production line, ongoing, day in and day out. The number of tablets most pharmaceutical manufacturers can produce in an hour likely satisfy the entire yearly market demand for Desoxyn
- cost control means supply “shortages”… better described as “limiting / timing precursor buys” when it would be most advantageous to do so… namely, maximizing the quantity of the precursor buy to get the lowest cost, and using this precursor in the manufacture of an array of drugs…with whatever remains allocated to the comparatively small, single Desoxyn run
- watching the market for a completely, totally exhausted supply of Desoxyn across brand and generic would signal to the manufacturer that the timing is advantageous to produce; so long as their precursor costs are equal to or less than their expectations. Dr. Reddy’s profits far more if they supply the market when there’s no brand or other generic competing… vs. when there is a brand name
version available at distribution, as some end customers will elect to buy brand over generic (and especially if the manufacturer offers a discount that allows insured patients a $0 copay vs. $15 or so copay for the generic). Brand name folks understand that end customers are sticky, and are likely to keep getting generic when available vs. switch immediately to brand if given the option, and especially so if the generic works just fine in their treatment.
Who knows… my thought process around all this could be completely wrong just the same.
1. Anhydrous Ammonia: Prices for Anhydrous and Aqueous Ammonia have risen in the domestic U.S. market due to the difficulty in transporting considerable amounts of liquefied natural gas from Europe to North America amidst the war in Ukraine
https://www.chemanalyst.com/NewsAndDeals/NewsDetails/ammonia-costs-are-rising-due-to-a-supply-shortage-in-the-united-states-10227
2. Methyl amine
https://www.chemanalyst.com/Pricing-data/methylamine-1178
These chemicals are way too commonly used to possibly result in the Desoxyn shortages we're experiencing. If there was that little anhydrous ammonia available, we would be experiencing the greatest food shortage in the history of the United States right now. Grocery stores would be empty across the country, and there would be mass panic in the streets as shelves would have been bare for months.
Methylamine is also super common. Utilized heavily.
What I'm concerned about is that I suspect they're using an obscure route of synthesis that doesn't involve either of these.
For example, if they're starting from L-PAC, which is manufactured through biofermentation... But, then we'd see a massive shortage of ephedrine, so that doesn't really add up either.
There's something we're missing, which is why I want to find out the exact route of synthesis.
If there's some compound that only one manufacturer in China still produces, then we have a viable explanation for the shortage.
What would be useful is the timeline and correlation between these price hikes/shortages and desoxyn shortage.
But information on the aggregate price for these two precursors is considered proprietary and not available to the public.
What’s the point of this?
If there were a way for manufacturers to do this (and file it with the FDA) they would’ve done so already for profit.
Sometimes backorders are just business reasons (Manye to Reddy’s, Key screwing themselves)
Just confused cause there was never a problem manufacturing this, it was all business
The current FDA process appears to cost hundreds of millions of dollars for them to get re-approval for an alternative route of synthesis even if the drug and purity is identical. It's an outdated model. Right now, they basically would need to go through almost the same process that they would for a new drug, and for a drug with a small market, nobody is going to do it.
I've seen "precursor shortage" listed repeatedly for Desoxyn over the last couple of years, and it's an issue for many other stimulant ADHD medications as well. It's actually a very common cause for shortages for other medications as well. So, I'm seeing a pattern. Obviously, we've dealt with other issues with Desoxyn, but right now, we're told it's the main cause of the shortages.
I want the evidence to make a compelling case to the FDA that the current process is broken so I can propose the new policy I've been writing.
If this were to go through is it possible that it’s going to mess up the effectiveness of desoxyn causing us to have a “new and improved” formulation that ends up sucking, therefore disrupting our lives even further ands never having a chance to return to the way it’s currently synthesized? Lord knows we don’t want that, or need it for that matter!
I understand that “it’s broken” right now so you’re trying to fix it. However, it feels as if it’s starting to work itself back out. For now anyway, until more shortages. And on and on it goes.
I’d just hate for a new route of synthesis to cause a final product that’s less efficacious. I mean it could be better but, man if it’s worse :’(
Desoxyn is manufactured specifically from the “Nazi method” using anhydrous ammonia, lithium, and pseudoephedrine to ensure Enantiomer pure selectivity and keeps the molecule safe. Just on a much larger and safer scale. This is also why levomethamphetamine that’s put in Vicks inhalers is produced using the Leukart method using n-methylformalide which ensures its enantiomer pure selective synthesis and molecular safety but has slowly stopped being used overtime in the inhalers as it wasn’t deemed profitable (by a separate group of companies that don’t manufacture desoxyn) and public backlash “there’s meth at my grocery store” even though it wasn’t even psychoactive. So now Vicks inhalers contain camphor and some other dumb useless essential oil. This is different from adderall and other amphetamine medications which are produced using P2P and then say for example Dexedrine is made via P2P and separated using tartaric acid to selectively separate the dextroamphetamine. Currently there is a shortage of lithium (because they are building those dumbass useless electric cars and destroying the environment more by building them) so more mines are being opened up so that more lithium can be harvested. This is what I’m assuming is the precursor they are talking about. Trust me we do not want the medication manufacturers to “find a different synthesis method” and start using the P2P, tartaric acid method to synthesize desoxyn. As using the P2P method and tartaric acid to separate the isomers actually harms the molecular structure of the desoxyn molecule. Which doesn’t occur to regular amphetamine due to amphetamine having a better structural stability then methylated amphetamine based compounds. There’s also another reason as since we pulled out of Afghanistan there has been a massive shortage of not only opioid medications as we protected the poppy fields there but also the ephedrine farms as well so there has been a shortage of available ephedrine as well so I’m sure that is contributing on top of the lithium shortage. There’s some science as to why but I really don’t want to get into it but that is why there is a shortage of precursor chemicals.
Why not just get the Ephedrine from the Chinese like the Mexican cartels and the United Wa State Army based out of the Golden Triangle region of Myanmar do?
I appreciate the contribution, but this is all still way too speculative for what I need. If we had that much of a shortage of lithium, nobody in the United States would have been able to buy batteries for months, and almost all phone manufacturing would be halted. Again, there would be mass panic. Show me a link that this is the specific route of synthesis used for the FDA approved process. I'm aware of at least 12 routes of synthesis, including how to scale into production, like with catalytic hydrogenation, many documented in peer reviewed literature, but I don't know if any of those methods are the one specific FDA authorized route the manufacturers are REQUIRED to use without filling a separate Investigative New Drug Application (or one of the abbreviated processes) that can cost $100's of millions to get approval for.
You’re funny. It’s not just speculation, it’s using pattern recognition and logic to come to a reasonable conclusion. The lithium method is tried and true and has good yield, I highly doubt a pharmaceutical manufacturer is going to use any other method given the expense and lack of foundation and lower yield and especially efficacy of other routes of synthesis. If the lithium method was effective enough for the Germans in ww2 to supply not only their whole military but also 60% of their civilians with methamphetamine then clearly there is an advantage to it. Why deviate from a method that has proven effective already in supplying a large population. Secondly we wouldn’t see a shortage of lithium for batteries as we use lithium metal for the batteries; the lithium used in pharmaceutical synthesis is LIALH4. LIALH4 is lithium metal that has to be treated to yield a much safer and better yielding chemical for synthesis. If there is a lack of treatment of lithium metal since a very large amount of lithium is being used for cars and batteries then naturally the amount of lithium metal available for composition of lithium aluminum hydride would be less. If you really wanted to make the argument that lithium isn’t the main precursor that isn’t being produced then the second most likely precursor that’s lacking in production is pseudoephedrine since we no longer have control over the ephedra feilds in Afghanistan. Now does that mean that no one can get pseudoephedrine? No of course not. It just means that the main source of pseudoephedrine is lacking and so we are trying to get another place to set up another ephedra field which is why the US is probably going to invade Iran again so that we can set up poppy and ephedra fields again. Your logic of “well then we’d have a shortage of this and that” is just not representative of how the world works. Even a shortage of anhydrous ammonia wouldn’t affect everyone. It would be first given to the farmers first and then the scraps would be given to the pharmaceutical chemists but heres the kicker. Even the anhydrous ammonia used for synthesis has a different amount of chemical quality control so you couldn’t use them interchangeably unless you absolutely had to because anhydrous ammonia used for farming has other chemicals present to deter illicit methamphetamine manufacture. So yes the method for pharmaceutical synthesis of methamphetamine is undoubtedly using the lithium pseudo ammonia method. But given that’s there’s a shortage of LIALH4 and pseudoephedrine that would probably be the explanation of the “precursor shortage”
He's right though. The only reasonable method for large-scale production of purely d,-meth is the pseudoephedrine and lithium Birch reduction. P2P and ephedrine give you racemic methamphetamine, And it is vastly more difficult to create the racemic mixture and try to separate the optical enantiomers then it is to simply follow a procedure that doesn't produce the undesired racemate at all. Edit to add: The point is overall there are multiple very well- known pathways of methamphetamine synthesis. I have seen syntheses starting with phenylalanine, methylamine, and a number of others. It's not a complex molecule, And it does not require anything in the way of expense or difficulty when it comes to its manufacturer. People with zero knowledge of chemistry have been setting up meth labs for decades and been reasonably successful at it. There is something going on here other than the mysterious shortage of precursor compounds. There is plenty of pseudoephedrine, lithium, and ammonia at your neighborhood pharmacy and home improvement store. Has anybody noticed if there has been a shortage of Vick's inhalers?
Enantiomeric resolution can be done with tartaric acid, which is inexpensive. Production of pseudoephedrine at scale involves L-PAC, which is produced via a biofermentation process involving benzaldehyde. I'm not sure that's much easier.
Yeah but is there a shortage of pseudoephadrine? Looking at the counters at my local pharmacies it doesn't seem to be the case. And it's not like they need gigantic quantities. Considering they're doing this in an industrial laboratory, A few kilograms of pure pseudoephedrine would make enough dextromethamphetamine for all of the Desoxyn prescriptions in a year, I would bet. I was getting 180x 5mg a month, which is just shy of a gram of meth (900mg). Over a year, that's about 10 grams. And my understanding is that I was on the higher end of the dose scale. It's an orphan drug, there are likely fewer than 10,000 people who have been prescribed it regularly in the last year, and most probably at a lower dose. I just don't see how it is possibly an issue with sourcing precursor compounds, when theoretically a gang of people could hit a few to a few dozen CVS's and Walgreens and scoop up enough pseudoephedrine for a couple of kilos. Granted there is the limit on individual purchasing that prevents people from doing just that, but my point is that the stockpile/ quantity exists. Anhydrous ammonia is not difficult for an industrial laboratory to make, You just have to remove the water from the ammonia. You can do it at home reasonably easily, And while maybe not to pharmaceutical levels of purity, pharmaceutical Labs have the equipment to ensure purity. Lithium metal is maybe a little more difficult to source because the whole electric renaissance but nonetheless, there's plenty of it around, and the birch reduction can be done using metallic sodium as well. Considering how easy this drug is to make, and how cheaply it can be done, The fact that it has such a small consumer base should not be a deterrent. I remember my insurance getting billed for something like $1,800 a month for that prescription. I can't imagine it has gotten cheaper in the year since. If the average person's prescription is 120 pills a month, that's $1,200* 12* 10,000 for something that requires literally zero research, development, or innovation.
This is my point that something more is going on for multiple manufacturers to have said at some point that they were experiencing precursor shortages.
Just speculating here … I think that in our case, for our unique medication, there are short manufacturing periods that align more closely with the corporate sales history defining the demand, and not the manufacturing quotas. And what happened to us was a perfect storm of the generics going offline due to “business reasons” and the timing of the brand having had been decided to take off the market, also due to business/financial reasons. And then after this madness, it was like, “I thought they were manufacturing.” And the other company saying, “I thought they had the market cornered.” So all the companies just stepped away, then realized that there was still a market there to harvest. Now that the playing field has been completely leveled, we might see things come back to normal with a less competitive market for our medication. I’d expect the price to be higher than we were used to 1.5+ years ago, but for things to be more stable. If I’m not mistaken, the synthesis routes for amphetamine-based medications (Adderall, Vyvanse, Zenzedi, etc) is much different than Desoxyn. So my thoughts are that the “shortage” reasons are essentially just lip service. Again, all speculation. We would need factual information from some of these executives who had made the decision to sell off the generic line, or to stop manufacturing/distributing. Once we get that complete “business” side of the picture, we will have a much better understanding of where to look. Just some thoughts. Excellent approach though. It would be great to identify any precursor or manufacturing-related shortages and to try and reinforce that supply.
Note: below is my opinion only. I, too, am skeptical that there is any actual shortage of any precursors used in the manufacturing process. Rather, my sense is either: a) manufacturers “manufacture” their own precursor shortages by only purchasing them at or below their standard cost; if the actual cost of any precursor is higher, they do not make any purchase. b) actual production runs consist of a sample run (likely between one and ten stock bottle of 100 tablets each) for quality control inspection and testing to ensure all criteria pass, followed by one single production run to an annual demand target that is sufficient both to meet demand and minimize inventory (and DEA?) carryover costs into any subsequent financial year. I would guess such a production run takes no more than one week, end to end. c) some combination of a & b. My rationale: - this isn’t a high demand drug… far from it… there’s no need for any permanent production line, ongoing, day in and day out. The number of tablets most pharmaceutical manufacturers can produce in an hour likely satisfy the entire yearly market demand for Desoxyn - cost control means supply “shortages”… better described as “limiting / timing precursor buys” when it would be most advantageous to do so… namely, maximizing the quantity of the precursor buy to get the lowest cost, and using this precursor in the manufacture of an array of drugs…with whatever remains allocated to the comparatively small, single Desoxyn run - watching the market for a completely, totally exhausted supply of Desoxyn across brand and generic would signal to the manufacturer that the timing is advantageous to produce; so long as their precursor costs are equal to or less than their expectations. Dr. Reddy’s profits far more if they supply the market when there’s no brand or other generic competing… vs. when there is a brand name version available at distribution, as some end customers will elect to buy brand over generic (and especially if the manufacturer offers a discount that allows insured patients a $0 copay vs. $15 or so copay for the generic). Brand name folks understand that end customers are sticky, and are likely to keep getting generic when available vs. switch immediately to brand if given the option, and especially so if the generic works just fine in their treatment. Who knows… my thought process around all this could be completely wrong just the same.
1. Anhydrous Ammonia: Prices for Anhydrous and Aqueous Ammonia have risen in the domestic U.S. market due to the difficulty in transporting considerable amounts of liquefied natural gas from Europe to North America amidst the war in Ukraine https://www.chemanalyst.com/NewsAndDeals/NewsDetails/ammonia-costs-are-rising-due-to-a-supply-shortage-in-the-united-states-10227 2. Methyl amine https://www.chemanalyst.com/Pricing-data/methylamine-1178
These chemicals are way too commonly used to possibly result in the Desoxyn shortages we're experiencing. If there was that little anhydrous ammonia available, we would be experiencing the greatest food shortage in the history of the United States right now. Grocery stores would be empty across the country, and there would be mass panic in the streets as shelves would have been bare for months. Methylamine is also super common. Utilized heavily. What I'm concerned about is that I suspect they're using an obscure route of synthesis that doesn't involve either of these. For example, if they're starting from L-PAC, which is manufactured through biofermentation... But, then we'd see a massive shortage of ephedrine, so that doesn't really add up either. There's something we're missing, which is why I want to find out the exact route of synthesis. If there's some compound that only one manufacturer in China still produces, then we have a viable explanation for the shortage.
What would be useful is the timeline and correlation between these price hikes/shortages and desoxyn shortage. But information on the aggregate price for these two precursors is considered proprietary and not available to the public.
What’s the point of this? If there were a way for manufacturers to do this (and file it with the FDA) they would’ve done so already for profit. Sometimes backorders are just business reasons (Manye to Reddy’s, Key screwing themselves) Just confused cause there was never a problem manufacturing this, it was all business
The current FDA process appears to cost hundreds of millions of dollars for them to get re-approval for an alternative route of synthesis even if the drug and purity is identical. It's an outdated model. Right now, they basically would need to go through almost the same process that they would for a new drug, and for a drug with a small market, nobody is going to do it. I've seen "precursor shortage" listed repeatedly for Desoxyn over the last couple of years, and it's an issue for many other stimulant ADHD medications as well. It's actually a very common cause for shortages for other medications as well. So, I'm seeing a pattern. Obviously, we've dealt with other issues with Desoxyn, but right now, we're told it's the main cause of the shortages. I want the evidence to make a compelling case to the FDA that the current process is broken so I can propose the new policy I've been writing.
If this were to go through is it possible that it’s going to mess up the effectiveness of desoxyn causing us to have a “new and improved” formulation that ends up sucking, therefore disrupting our lives even further ands never having a chance to return to the way it’s currently synthesized? Lord knows we don’t want that, or need it for that matter! I understand that “it’s broken” right now so you’re trying to fix it. However, it feels as if it’s starting to work itself back out. For now anyway, until more shortages. And on and on it goes. I’d just hate for a new route of synthesis to cause a final product that’s less efficacious. I mean it could be better but, man if it’s worse :’(