What could be done to lower the cost of expensive generic drugs

[brickbacon]

@Ruken

You wrote that it’s not illegal for companies to sell alternatives. But I can’t sell it tonight. I have a company.

I guess you do not understand the difference between saying it’s not illegal to sell alternatives (which are legal and plentiful), and saying there is no regulations or prohibitions on sales. Maybe I can make this clearer for you. Is it legal to sell guns? Yes, it is. Despite there being regulations on which guns can be sold, and to whom they can be sold, selling guns is legal. This is not a contradiction or incorrect statement despite your ridiculous insinuation. Doubly so because, as I pointed out, there are already alternatives on the market for Epi-pens.

@puddleglum

It is legal to make generic drugs, but they still need to be approved by the FDA. A company with no FDA approved generic competitors has just as much of a monopoly as a company with a patent on a drug.

Agreed, but that de facto monopoly has little to do with the FDA in most cases. Again, there are multiple Epi-pen alternatives. Why can they still charge $600? Because the market is broken, because they are greedy, and most importantly, because the market can bear the price because we are a rich country and few are incentivized to lower the costs.

Again, Daraprim HAD multiple approved competitors IIRC. Most stopped making it because it wasn’t worth it.

@puddleglum

In the US Epipen has one competitor in europe they have eight competitors and of course Europe has cheaper Epipens. Companies have been trying to sell generic Epipens for at least 7 years but no one has been able to get it through the FDA.

And? I fully acknowledge this is a problem. The point though is that this has little to do with prices. Again, I can inject someone using a plain old syringe with epinephrine. Even with one competitor, the epi-pen should not have 98% of the market in a functional market.

@puddleglum

There is plenty of money to be made in generics for small populations as long as the burden to service that market is not too great.

The burden isn’t just approval. It’s going against a huge corporation that can cut prices temporarily for long enough to put you in the poorhouse. It’s going against a name brand when you are not strictly a generic version. It’s investing in something with a really uncertain return. There are so many labs, so many supply chains, so many pharmacies, etc. All of them would rather get a cut of a $600 drug from a company with deep pockets than a $100 one from a unknown company.

It’s the same game plan Apple used for a long time. Don’t want anyone copying your iphone? Buy all the screens in China, and book every boat that can get here by the holiday season. If that doesn’t work, just buy the company trying to upset steal your golden egg. Despite what you are saying, it’s not just a matter of having some competitor.

@puddleglum

Most drugs are cheap to manufacture and the real cost is in creating the drugs and getting them approved. Generics don’t have to create the drugs and if approval was cheap there would be a profitable market for almost any drug. The only reason Daraprim’s strategy worked is that it is so hard to get approval to sell a drug. If it were easy to get a drug approved then trying to corner the market in any particular drug would be pointless.

Why do you think they were able to corner the market? Say I find one of these drugs where there are around 10k scripts a year, and the drug is $5/pill. Say the current market is couple million, but demand is inelastic. Now, evil corp comes in and buys the pill, and jacks up the price to $1000/pill. Sure, it might make sense to come it and undercut this price. Let’s even say the approval times goes from around 4 years to one. By the time I get there, I cannot expect the market to remain $400 million. It, in theory, could go back to $2 million or less. The lower bound makes it not worthwhile for me. Let’s say my break even point is 20% market share of a $50 million market. Why would I invest millions to go against a company with market experience and tens of millions in profits to sink me if need be? At best, you get two companies deciding to be slightly less greedy.

[watchwolf49]

Apparently, Imprimis is now making a substitute Daraprim at [sup]1[/sup]/[sub]750[/sub]th the price {Cite}.

[Fiveyearlurker]

@watchwolf49

Apparently, Imprimis is now making a substitute Daraprim at [sup]1[/sup]/[sub]750[/sub]th the price {Cite}.

Imprimis is long on press releases (which is what your cite is) and short on ever producing a single FDA approved pharmaceuticals. Which, in fairness, is roughly on par with the number of FDA approved drugs from most shell corporations founded for the purposes of mineral exploration.

“We were incorporated in Delaware in January 2006 as Bywater Resources, Inc. in
order to conduct mineral exploration activities. We changed our name to Transdel
Pharmaceuticals, Inc. on September 10, 2007. On September 17, 2007, we acquired
Trans-Pharma Corporation, a privately held Nevada”

[AK84]

I was in the US recently for a wedding and on the day of said wedding, I got bad cold. At the local Walgreene, one box of Tylenol Cold and Flu (24 tablets) costs about $10. Back home in Pakistan, I get Panadol Cold and Flu (aka the same thing) for $2.

Nearly had a stroke.

[Wesley_Clark]

@AK84

I was in the US recently for a wedding and on the day of said wedding, I got bad cold. At the local Walgreene, one box of Tylenol Cold and Flu (24 tablets) costs about $10. Back home in Pakistan, I get Panadol Cold and Flu (aka the same thing) for $2.

Nearly had a stroke.

OTC drugs aren’t terrible here if you buy generics and buy them separately. Cold & flu is probably 3 or 4 OTC meds (dextromethorphan, tylenol, guaifenisen, pseudoephdrine I assume). Those are all pretty cheap if bought individually and generics.

[Tim_T-Bonham.net]

@AK84

Nearly had a stroke.

Don’t do that – the charges for treating one could bankrupt you.

[BigT]

@Fiveyearlurker

Three companies (Teva, Adamis and Sanofi) tried to make an epi pen competitor and failed. Two didn’t get FDA approval and one was recalled when it failed. Anyone reading this thread is welcome to take a stab (see what I did there?) at it if they think there is a way to do it.

I think the solution is that the process of drug approval needs to be streamlined and made less expensive; there would be at least one of those companies devices on the market as an alternative if the process was simplified a bit. Of course, the general public will have to accept that this may come at a sacrifice of safety to some extent.

No need to make a competitor. The autoinjector patent that they are using was filed in 1977, and patents last 20 years in the US.

So they should be able to use the same autoinjector. Sure, maybe they’ve since improved upon it. But the original is still there, so use that.

At least, this is my understanding. But it seems so simple that there must be something wrong…

[BigT]

@Fiveyearlurker

Imprimis is long on press releases (which is what your cite is) and short on ever producing a single FDA approved pharmaceuticals. Which, in fairness, is roughly on par with the number of FDA approved drugs from most shell corporations founded for the purposes of mineral exploration.

“We were incorporated in Delaware in January 2006 as Bywater Resources, Inc. in
order to conduct mineral exploration activities. We changed our name to Transdel
Pharmaceuticals, Inc. on September 10, 2007. On September 17, 2007, we acquired
Trans-Pharma Corporation, a privately held Nevada”

Literally everything I’ve read about it says they are currently offering their Daraprim alternative for $1 as promised, and one article even mentioned them taking 20% of the market.

Of course they haven’t produced an FDA approved pharmaceutical. That’s not what they do. They are a compounding pharmacy. That gets them around the generics problem, as you can legally compound any FDA approved drug with another one.

The real thing you need to point out is that they aren’t FDA regulated, but are regulated on a state level. There have been some contamination problems at compounding pharmacies.

Still, if 20% of Daraprim users are happy with them, that suggests they are doing a good job. Whether that number has been fact checked or just came from a press release, I don’t know.

[puddleglum]

@brickbacon

I guess you do not understand the difference between saying it’s not illegal to sell alternatives (which are legal and plentiful), and saying there is no regulations or prohibitions on sales. Maybe I can make this clearer for you. Is it legal to sell guns? Yes, it is. Despite there being regulations on which guns can be sold, and to whom they can be sold, selling guns is legal. This is not a contradiction or incorrect statement despite your ridiculous insinuation. Doubly so because, as I pointed out, there are already alternatives on the market for Epi-pens.

Agreed, but that de facto monopoly has little to do with the FDA in most cases. Again, there are multiple Epi-pen alternatives. Why can they still charge $600? Because the market is broken, because they are greedy, and most importantly, because the market can bear the price because we are a rich country and few are incentivized to lower the costs.

Again, Daraprim HAD multiple approved competitors IIRC. Most stopped making it because it wasn’t worth it.

And? I fully acknowledge this is a problem. The point though is that this has little to do with prices. Again, I can inject someone using a plain old syringe with epinephrine. Even with one competitor, the epi-pen should not have 98% of the market in a functional market.

The burden isn’t just approval. It’s going against a huge corporation that can cut prices temporarily for long enough to put you in the poorhouse. It’s going against a name brand when you are not strictly a generic version. It’s investing in something with a really uncertain return. There are so many labs, so many supply chains, so many pharmacies, etc. All of them would rather get a cut of a $600 drug from a company with deep pockets than a $100 one from a unknown company.

It’s the same game plan Apple used for a long time. Don’t want anyone copying your iphone? Buy all the screens in China, and book every boat that can get here by the holiday season. If that doesn’t work, just buy the company trying to upset steal your golden egg. Despite what you are saying, it’s not just a matter of having some competitor.

Why do you think they were able to corner the market? Say I find one of these drugs where there are around 10k scripts a year, and the drug is $5/pill. Say the current market is couple million, but demand is inelastic. Now, evil corp comes in and buys the pill, and jacks up the price to $1000/pill. Sure, it might make sense to come it and undercut this price. Let’s even say the approval times goes from around 4 years to one. By the time I get there, I cannot expect the market to remain $400 million. It, in theory, could go back to $2 million or less. The lower bound makes it not worthwhile for me. Let’s say my break even point is 20% market share of a $50 million market. Why would I invest millions to go against a company with market experience and tens of millions in profits to sink me if need be? At best, you get two companies deciding to be slightly less greedy.

You mention injecting someone with a syringe full of epinephrine. A company tried to get that approved as an alternative to the Epipen and was not able to get it approved. When the FDA is not approving a 2,000 year old technology, it is obvious that there is a problem.
If you reduce the approval time from four years to two months then it become pointless for companies to jack up prices since any windfall profits would just invite competitors to join the market.

[Ruken]

@puddleglum

You mention injecting someone with a syringe full of epinephrine. A company tried to get that approved as an alternative to the Epipen and was not able to get it approved. When the FDA is not approving a 2,000 year old technology, it is obvious that there is a problem.

No I think it was an autoinjector. The drug itself is plenty available (although I don’t if you can get a home prescription for epinephrine), but medical device in question is less so. Adrenaclick is still available, but it works a little different so pharmacies can’t just sub it out like they could if another brand of pyrimethamine were available.

[Ruken]

@brickbacon

I guess you do not understand the difference between saying it’s not illegal to sell alternatives (which are legal and plentiful), and saying there is no regulations or prohibitions on sales. Maybe I can make this clearer for you. Is it legal to sell guns? Yes, it is.

Yes, it is legal to sell guns. Any number of companies and individuals can sell guns, without having that individual gun brand approved by ATF. Show me the legal alternatives to Daraprim. Let’s count them. It doesn’t matter if I’m already an approved drug manufacture. I could be Chuck Pfizer risen from the grave, with the entire company at my disposal. I’m still filling out an ANDA. And waiting. puddleglum wrote that prices rise when it is illegal for companies to sell alternatives. And until you get that approval, it is illegal for your company to sell an alternative. For years. That’s not a patent issue.
There are plenty of manufacturers of pyrimethamine. That’s why it’s cheap. Except here.

Yes, there appears to be a compounding pharmacy loophole. That should provide some downward pressure, but not as much as if there were substantial legal competition.

[Fiveyearlurker]

@BigT

Literally everything I’ve read about it says they are currently offering their Daraprim alternative for $1 as promised, and one article even mentioned them taking 20% of the market.

Of course they haven’t produced an FDA approved pharmaceutical. That’s not what they do. They are a compounding pharmacy. That gets them around the generics problem, as you can legally compound any FDA approved drug with another one.

The real thing you need to point out is that they aren’t FDA regulated, but are regulated on a state level. There have been some contamination problems at compounding pharmacies.

Still, if 20% of Daraprim users are happy with them, that suggests they are doing a good job. Whether that number has been fact checked or just came from a press release, I don’t know.

Literally everything I see about Imprimis is coming from Imprimis. I see no evidence from anywhere other than press releases, articles quoting press releases and articles quoting the Imprimis CEO that they are selling anything at all. I’m OK with being wrong here, but I can’t find any independent numbers to support that Imprimis is doing anything but getting some press.

Note, that I would support this sort of approach to generics, but it goes along with the idea that if people want this as an alternative, there is almost certainly a cost at the level of safety. The Epi Pen alternative, Auvi-Q, was recalled when it turned out to be delivering the wrong dose. That was caught at the level of the FDA. If we turn to compounding companies, we have to accept that the level of scrutiny will be lower. I’m not saying that is the wrong move, just that there is no opportunity for 100% safe and 100% cheap, and we have to make a decision as to where the sweet spot is.

[Ruken]

@Fiveyearlurker

Literally everything I see about Imprimis is coming from Imprimis. I see no evidence from anywhere other than press releases, articles quoting press releases and articles quoting the Imprimis CEO that they are selling anything at all. I’m OK with being wrong here, but I can’t find any independent numbers to support that Imprimis is doing anything but getting some press.

Their website does have different doses of it (mixed with another drug) for sale, but it asked for login information before I could get information about price and availability.

[brickbacon]

@puddleglum

You mention injecting someone with a syringe full of epinephrine. A company tried to get that approved as an alternative to the Epipen and was not able to get it approved. When the FDA is not approving a 2,000 year old technology, it is obvious that there is a problem.

This is false. Why did you think this was true?

@puddleglum

If you reduce the approval time from four years to two months then it become pointless for companies to jack up prices since any windfall profits would just invite competitors to join the market.

It probably isn’t possible to approve a drug in 2 months. It’s not as if the FDA has limitless resources.

@Ruken

Yes, it is legal to sell guns. Any number of companies and individuals can sell guns, without having that individual gun brand approved by ATF.

Rather, guns and arms that can be sold to (certain) civilians are regulated by other government agencies. You missed the point though.

@Ruken

Show me the legal alternatives to Daraprim.

There aren’t multiple alternatives because people didn’t want to sell it anymore prior to the market for it being increased. It has nothing to do with legality. People willingly stopped manufacturing it. More importantly, there is at least one alternative now.

More importantly, this is going to keep happening because the market incentives are broken. Now, about 80% of drugs are generics. Jacking up the prices is increasingly where the money is going to come from because making new drugs that are mildly more efficacious is much riskier and expensive. Think about this. If the demonstrated market for Daraprim is not X but rather 55X, why would you think a competitor who enters the market wants to shrink the market back down to X? Competition might make it 20X or 10X, but the incentives mean no one is desirous to compete on price alone.

@Ruken

puddleglum wrote that prices rise when it is illegal for companies to sell alternatives.

Wrong, he wrote:

@puddleglum

Generally the reason drug prices are high is that it is illegal for companies to sell alternatives, leaving one company with a monopoly.

It is in fact NOT illegal to sell alternatives. Why cannot comprehend basic English is beyond me, but the above statement is false. First, because there is no prohibition on selling alternatives; they just need to be approved. Second, for every drug discussed and more, there actually is a commercially available alternative.

@Ruken

Their website does have different doses of it (mixed with another drug) for sale, but it asked for login information before I could get information about price and availability.

They must be doing this illegally since it’s illegal to sell alternatives, right?

[puddleglum]

@brickbacon

This is false. Why did you think this was true?

It probably isn’t possible to approve a drug in 2 months. It’s not as if the FDA has limitless resources.

It is in fact NOT illegal to sell alternatives. Why cannot comprehend basic English is beyond me, but the above statement is false. First, because there is no prohibition on selling alternatives; they just need to be approved. Second, for every drug discussed and more, there actually is a commercially available alternative.

They must be doing this illegally since it’s illegal to sell alternatives, right?

Adamis pharmaceuticals filed an application to get a pre filled syringe of epinephrine approved by the FDA in May of 2014. That application has still not been approved. That is why I think the FDA is not approving a syringe of epinephrine.
Epinephrine is a 100 year old drug, syringes are a 2,000 year old technology. Why does it take over 4 years to get a syringe full of epinephrine approved. It should only take months.
It is only legal to sell approved drugs, if there are no approved alternative drugs then it is illegal to sell alternatives. Why cannot comprehend basic English indeed.

[brickbacon]

@puddleglum

Adamis pharmaceuticals filed an application to get a pre filled syringe of epinephrine approved by the FDA in May of 2014. That application has still not been approved. That is why I think the FDA is not approving a syringe of epinephrine.

You do realize a PRE-FILLED syringe is different from using a new syringe to inject someone, right? Once again, your contention is false.

@puddleglum

Epinephrine is a 100 year old drug, syringes are a 2,000 year old technology. Why does it take over 4 years to get a syringe full of epinephrine approved. It should only take months.

Because there are hundreds of other people in line and because you don’t understand what you are talking about since you clearly do not understand the process. Here is some of what happened which you can get just by searching:

In March of 2015, the FDA issued a CRL regarding the Adamis NDA. The substance of the CRL related to the Chemistry, Manufacturing and Controls (“CMC”) section, or more specifically, the volume of dose delivered by the syringe, including the ability to deliver volume within the levels contained in the labeling claim and as required by the FDA. No other safety or efficacy issues were raised, and the NDA remained open until the issues could be resolved. Adamis took approximately five months to re-engineer the design of the product, manufacture prototypes, and test the new design. In August 2015, Adamis had a telephonic meeting with the FDA to present details of the new design and discuss the preliminary data. Following that meeting, Adamis continued preparations for manufacture of a commercial-ready product as well as testing and validation. Once completed, Adamis revised the NDA to include details of the new design and delivered volume data, and then in December resubmitted the application.

Because of the improvements that were made to the PFS in response to the FDA’s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. The Company believes that it can finalize the study protocols with the FDA and complete the additional testing within a relatively short period of time at an immaterial cost, and submit the data back to the FDA sometime in the second half of 2016. It should be noted that the Company has successfully completed the “volume delivery” issue that was associated with the initial CRL. The FDA has indicated that the NDA will remain open until these issues are resolved.

Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We look forward to working with the FDA to resolve the remaining issues. Our goal is to submit the protocols for these studies to the FDA within a matter of weeks and begin the testing as soon as we receive their feedback. We are confident that we can deliver all of the data requested by FDA and will continue to work closely with the agency to facilitate their continued review of our NDA. Adamis remains committed to bringing the epinephrine PFS to market.”

@puddleglum

It is only legal to sell approved drugs, if there are no approved alternative drugs then it is illegal to sell alternatives. Why cannot comprehend basic English indeed.

HELLO! There are approved alternatives. Did you miss that glaringly obvious fact? More importantly, the prohibition is against UNAPPROVED DRUGS, not alternatives. This is why I cannot sell an unapproved pain killer for which there are already a handful of alternatives. This, again, is why there are many drugs with many alternatives, including epi-pins and daraprim. I’ll try one more time to analogize this for you and the other slow people: is it illegal to practice medicine or the law because you have to be licensed to do so?

More germane to the point, this is, again, not really why generic drugs are expensive, and more competition is not really going to fix this issue.

[Ruken]

@brickbacon

There aren’t multiple alternatives because people didn’t want to sell it anymore prior to the market for it being increased. It has nothing to do with legality. People willingly stopped manufacturing it. More importantly, there is at least one alternative now.

There are, right now, multiple manufacturers of pyrimethamine tablets. Only one has FDA approval. If the others cannot sell their tablets legally in the United States, then it is illegal for them to sell them in the United States. It might not be in four years, but right now is not four years from now.

[Ruken]

@brickbacon

I’ll try one more time to analogize this for you and the other slow people: is it illegal to practice medicine or the law because you have to be licensed to do so?

Credentialism is a common means of decreasing competition. If it were ever so extreme as to restrict the legal providers of these services to one company, then yes, it would be illegal for anyone else to provide these services.

[Jonathan_Chance]

@brickbacon

HELLO! There are approved alternatives. Did you miss that glaringly obvious fact? More importantly, the prohibition is against UNAPPROVED DRUGS, not alternatives. This is why I cannot sell an unapproved pain killer for which there are already a handful of alternatives. This, again, is why there are many drugs with many alternatives, including epi-pins and daraprim. I’ll try one more time to analogize this for you and the other slow people: is it illegal to practice medicine or the law because you have to be licensed to do so?

More germane to the point, this is, again, not really why generic drugs are expensive, and more competition is not really going to fix this issue.

You will calm the heck down. No warning issued but anything further will earn them.

[dropzone]

@AK84

Nearly had a stroke.

That would’ve been the Phenylephrine HCI. It’ll mess with your blood pressure.