5 ms·

Why haven't competitors entered the market with cheaper products?

by helloworld 10y ago

FLUX-YOU 10y ago
Patent on the injection system I believe
blackguardx 10y ago
It isn't a free market. There are significant barriers to entry for medical products.
pg_is_a_butt 10y ago
because you're all cowards, and the justice department takes money from the companies who are leveraging a medical survival need to generate profits for a private company who built themselves on grants and research paid with public money.
serge2k 10y ago
> Last year, the drug maker Sanofi recalled a competing product, Auvi-Q, because it may not have been delivering the correct amount of epinephrine, leaving the EpiPen as the primary emergency treatment for severe allergic reactions.
- JunkDNA 10y ago
  To all the folks in this thread suggesting 3D printing and all sorts of other ideas, keep in mind that Sanofi is not some fly-by-night or scrappy startup. They are a major pharmaceutical company with decades of experience manufacturing pharmaceuticals and the quality control that is required and even they couldn't get it right. They actually had a very innovative product. It was much smaller than the EpiPen and used voice prompts to tell you how to administer the drug (people in the heat of the moment sometimes don't remember to leave the EpiPen in long enough for a proper dose to be fully administered). I'm frankly mystified how they botched things so badly that they had to pull the product.
  - snowwrestler 10y ago
    I have to wonder how well expertise in pharmaceutical manufacturing really translates into expertise in manufacturing an auto-injector. The hard part of the EpiPen is not the drug, it's the mechanics.
Animats 10y ago
They did. Windgap[1] took venture capital, took state funding from Massachusetts back in 2012, and didn't ship the product. Cool web site, though. Sanofi tried, but their product misfired at least 26 times and was recalled.[2] Teva tried, and their product was rejected by the FDA because of problems; they're going to try again with a new model in 2017.[3] [1] http://www.windgapmedical.com/ http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-down-teva-s-epipen-copy-putting-mylan-cruise-control http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...
- leereeves 10y ago
  Three companies tried and failed? It sounds like it's harder than we might think to make this work. Given that, and the low volumes, it might not be that profitable even at $600 per sale.
  - ViViDboarder 10y ago
    But that R&D was spent years ago.
    - leereeves 10y ago
      I meant for a new entrant.
  - Animats 10y ago
    The companies that tried to enter the business were drug companies, not device companies. No expertise in volume manufacturing of medical-grade injection-molded plastic devices. There are companies which can do that.[1] There are automatic inspection technologies which can detect even minor flaws.[2] But the typical injection molding vendor isn't that good. Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding. [1] http://www.advancedmt.com/wp-content/uploads/2012/10/amt_medicalsyringe_CS.pdf http://www.advancedmt.com/wp-content/uploads/2012/10/amt_med... [2] http://www.vision-systems.com/articles/print/volume-9/issue-8/features/industrial-automation/automated-inspection-station-rejects-defects.html http://www.vision-systems.com/articles/print/volume-9/issue-...
refurb 10y ago
They have, the products weren't up to snuff and were recalled.
ccleve 10y ago
There are really two villains here, Mylan, of course, but more importantly, the FDA. FDA regulations make the cost of bringing a new medical device to the market absurd. There are no competitors because the time and effort to bring a competing device is so ridiculously high that it doesn't pay to do so. I have a child with a peanut allergy. I am worried every damn day of my life. I see articles about people who die every year because they didn't have an Epipen handy. The numbers of people who die will increase. I want to see FDA bureaucrats hauled to those funerals so they can see what they've done.
- RockyMcNuts 10y ago
  hmmh... what's the reg, specifically? what I see is an unholy alliance between the regulators and industry to extract max profits. if you don't have an approving authority for e.g. Epipens, it seems to be that you get something like the supplements industry which is mostly marketing and exploiting the ignorant. you need some IP protection for the crazy amount of incredibly skilled R&D and massive testing that goes into an Epipen but this is ridiculous. drug and medical device companies merge for maximum market power vs. insurers, who try to merge for maximum market power against drug companies and doctors/hospitals. eventually you'll have just one insurer and one drug company and one hospital company and you can nationalize the whole thing. just kidding, but I see Obamacare failing if it can't evolve, prices continuing to go up, and eventually everyone demanding a single-payer solution.
  - Spooky23 10y ago
    Obamacare is driving regional healthcare provider consolidation as well as insurer consolidation. As drug innovation has slowed, single payer US healthcare will be the solution to these problems. Nationalize some/all of the provider networks and drugs like this become built to spec government bids where buying power drives cost down.
- dfsegoat 10y ago
  So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really? I also find your comment pretty uninformed considering that the FDA just paved the way for generic drug makers to basically "knock-off" super expensive biologic drugs like Humira and Enbrel which were previously covered by similar patents. The FDA has it's problems - but to say that it is an agency staffed by people who don't care ("bureaucrats") who typically have both Ph.D and M.D.s and have dedicated their careers to ensure patients have safe and effective medicine is unfair. edit: grammar.
jevinskie 10y ago
I'm confused about this myself. I used to receive EpiPen brand auto-injectors. At some point, I started receiving Lineage Therapeutics auto-injectors (supposedly an Adrenaclick generic) instead. According to [0] they are _not_ equivalent to EpiPens according to the FDA. I'm not sure if my primary care physician or my old pharmacist (CVS chain) are at fault for not informing me of the differences. My generic prescription costs me, with insurance, $15 for two 0.3 mg autoinjectors. Insurance has covered four twin auto-injector packs (8 individual auto-injectors total) without any hassle. Either way, I have trained and informed myself on the proper use of the generic Adrenaclick auto-injector. From what I gather, the main differences are that there are two safety covers on both sides of the injector (instead of a cover on just the non-needle side) and the method of determining whether a dose was supposedly administered correctly (mainly, the EpiPen's needle cover is extended vs just observing an extended needle on the Adrenaclick). I am left to presume that their therapeutic effectiveness is the same, even though the FDA may not explicitly declare it as so. I will consult my physician and current pharmacist (local, non-chain pharmacy with excellent focus on patient care) to determine if I have any misunderstandings. I have also trained the people most likely to administer epinephrine to myself (family, friends, coworkers) the particular procedures of Adrenaclick administration, so I am not too worried about procedural differences between EpiPens and my generic auto-injector. Still, I am left wondering what the therapeutic difference between an EpiPen and a generic Adrenaclick alternative really is. I do understand that different administration procedures are a problem for training, but I would expect the actual therapeutic effects of both auto-injectors to be similar --- if used administered according to directions. [0]: http://www.pharmacytimes.com/p2p/p2pepinephrine-0910 http://www.pharmacytimes.com/p2p/p2pepinephrine-0910
- stan_rogers 10y ago
  They're not equivalent (that is, it can't be freely substituted by a dispenser) only because the devices are mechanically different. Knowing how to use an EpiPen doesn't mean knowing how to use an Adrenaclick, even if they are aministering the same drug in the same dose using more-or-less the same kind of mechanism. It's that "more-or-less" that's the key; since they differ in the way they're used and administration is quite time-sensitive, you can't assume that a person trained to use an EpiPen will be able to use an Adrenaclick properly when the time comes (or vice versa).
ec109685 10y ago
The epi pen wasn't extremely expensive until recently, so competitors had to take a different and riskier angle to make it in the market. Perhaps now a carbon copy will do well.

Why haven't competitors entered the market with cheaper products?

FLUX-YOU 10y ago

Patent on the injection system I believe

blackguardx 10y ago

It isn't a free market. There are significant barriers to entry for medical products.

pg_is_a_butt 10y ago

because you're all cowards, and the justice department takes money from the companies who are leveraging a medical survival need to generate profits for a private company who built themselves on grants and research paid with public money.

serge2k 10y ago

> Last year, the drug maker Sanofi recalled a competing product, Auvi-Q, because it may not have been delivering the correct amount of epinephrine, leaving the EpiPen as the primary emergency treatment for severe allergic reactions.

JunkDNA 10y ago
To all the folks in this thread suggesting 3D printing and all sorts of other ideas, keep in mind that Sanofi is not some fly-by-night or scrappy startup. They are a major pharmaceutical company with decades of experience manufacturing pharmaceuticals and the quality control that is required and even they couldn't get it right. They actually had a very innovative product. It was much smaller than the EpiPen and used voice prompts to tell you how to administer the drug (people in the heat of the moment sometimes don't remember to leave the EpiPen in long enough for a proper dose to be fully administered). I'm frankly mystified how they botched things so badly that they had to pull the product.
- snowwrestler 10y ago
  I have to wonder how well expertise in pharmaceutical manufacturing really translates into expertise in manufacturing an auto-injector. The hard part of the EpiPen is not the drug, it's the mechanics.

Animats 10y ago

They did. Windgap[1] took venture capital, took state funding from Massachusetts back in 2012, and didn't ship the product. Cool web site, though. Sanofi tried, but their product misfired at least 26 times and was recalled.[2] Teva tried, and their product was rejected by the FDA because of problems; they're going to try again with a new model in 2017.[3] [1] http://www.windgapmedical.com/ http://www.windgapmedical.com/ [2] https://www.auvi-q.com/ https://www.auvi-q.com/ [3] http://www.fiercepharma.com/sales-and-marketing/fda-swats-down-teva-s-epipen-copy-putting-mylan-cruise-control http://www.fiercepharma.com/sales-and-marketing/fda-swats-do...

leereeves 10y ago
Three companies tried and failed? It sounds like it's harder than we might think to make this work. Given that, and the low volumes, it might not be that profitable even at $600 per sale.
- ViViDboarder 10y ago
  But that R&D was spent years ago.
  - leereeves 10y ago
    I meant for a new entrant.
- Animats 10y ago
  The companies that tried to enter the business were drug companies, not device companies. No expertise in volume manufacturing of medical-grade injection-molded plastic devices. There are companies which can do that.[1] There are automatic inspection technologies which can detect even minor flaws.[2] But the typical injection molding vendor isn't that good. Consider the typical failure rate of ball-point pens. That's consumer-grade injection molding. [1] http://www.advancedmt.com/wp-content/uploads/2012/10/amt_medicalsyringe_CS.pdf http://www.advancedmt.com/wp-content/uploads/2012/10/amt_med... [2] http://www.vision-systems.com/articles/print/volume-9/issue-8/features/industrial-automation/automated-inspection-station-rejects-defects.html http://www.vision-systems.com/articles/print/volume-9/issue-...

refurb 10y ago

They have, the products weren't up to snuff and were recalled.

ccleve 10y ago

There are really two villains here, Mylan, of course, but more importantly, the FDA. FDA regulations make the cost of bringing a new medical device to the market absurd. There are no competitors because the time and effort to bring a competing device is so ridiculously high that it doesn't pay to do so. I have a child with a peanut allergy. I am worried every damn day of my life. I see articles about people who die every year because they didn't have an Epipen handy. The numbers of people who die will increase. I want to see FDA bureaucrats hauled to those funerals so they can see what they've done.

RockyMcNuts 10y ago
hmmh... what's the reg, specifically? what I see is an unholy alliance between the regulators and industry to extract max profits. if you don't have an approving authority for e.g. Epipens, it seems to be that you get something like the supplements industry which is mostly marketing and exploiting the ignorant. you need some IP protection for the crazy amount of incredibly skilled R&D and massive testing that goes into an Epipen but this is ridiculous. drug and medical device companies merge for maximum market power vs. insurers, who try to merge for maximum market power against drug companies and doctors/hospitals. eventually you'll have just one insurer and one drug company and one hospital company and you can nationalize the whole thing. just kidding, but I see Obamacare failing if it can't evolve, prices continuing to go up, and eventually everyone demanding a single-payer solution.
- Spooky23 10y ago
  Obamacare is driving regional healthcare provider consolidation as well as insurer consolidation. As drug innovation has slowed, single payer US healthcare will be the solution to these problems. Nationalize some/all of the provider networks and drugs like this become built to spec government bids where buying power drives cost down.
dfsegoat 10y ago
So, The FDA, because they require drug and device makers to demonstrate efficacy and safety by going through a rigorous clinical trial process, are evil? Really? I also find your comment pretty uninformed considering that the FDA just paved the way for generic drug makers to basically "knock-off" super expensive biologic drugs like Humira and Enbrel which were previously covered by similar patents. The FDA has it's problems - but to say that it is an agency staffed by people who don't care ("bureaucrats") who typically have both Ph.D and M.D.s and have dedicated their careers to ensure patients have safe and effective medicine is unfair. edit: grammar.

jevinskie 10y ago

I'm confused about this myself. I used to receive EpiPen brand auto-injectors. At some point, I started receiving Lineage Therapeutics auto-injectors (supposedly an Adrenaclick generic) instead. According to [0] they are _not_ equivalent to EpiPens according to the FDA. I'm not sure if my primary care physician or my old pharmacist (CVS chain) are at fault for not informing me of the differences. My generic prescription costs me, with insurance, $15 for two 0.3 mg autoinjectors. Insurance has covered four twin auto-injector packs (8 individual auto-injectors total) without any hassle. Either way, I have trained and informed myself on the proper use of the generic Adrenaclick auto-injector. From what I gather, the main differences are that there are two safety covers on both sides of the injector (instead of a cover on just the non-needle side) and the method of determining whether a dose was supposedly administered correctly (mainly, the EpiPen's needle cover is extended vs just observing an extended needle on the Adrenaclick). I am left to presume that their therapeutic effectiveness is the same, even though the FDA may not explicitly declare it as so. I will consult my physician and current pharmacist (local, non-chain pharmacy with excellent focus on patient care) to determine if I have any misunderstandings. I have also trained the people most likely to administer epinephrine to myself (family, friends, coworkers) the particular procedures of Adrenaclick administration, so I am not too worried about procedural differences between EpiPens and my generic auto-injector. Still, I am left wondering what the therapeutic difference between an EpiPen and a generic Adrenaclick alternative really is. I do understand that different administration procedures are a problem for training, but I would expect the actual therapeutic effects of both auto-injectors to be similar --- if used administered according to directions. [0]: http://www.pharmacytimes.com/p2p/p2pepinephrine-0910 http://www.pharmacytimes.com/p2p/p2pepinephrine-0910

stan_rogers 10y ago
They're not equivalent (that is, it can't be freely substituted by a dispenser) only because the devices are mechanically different. Knowing how to use an EpiPen doesn't mean knowing how to use an Adrenaclick, even if they are aministering the same drug in the same dose using more-or-less the same kind of mechanism. It's that "more-or-less" that's the key; since they differ in the way they're used and administration is quite time-sensitive, you can't assume that a person trained to use an EpiPen will be able to use an Adrenaclick properly when the time comes (or vice versa).

ec109685 10y ago

The epi pen wasn't extremely expensive until recently, so competitors had to take a different and riskier angle to make it in the market. Perhaps now a carbon copy will do well.