FDA Approves First Generic Version of EpiPen (go.com) 136
An anonymous reader quotes a report from ABC News: The U.S. Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto injector for the emergency treatment of allergic reactions. The approval is part of the FDA's "longstanding commitment" to providing access to low-cost generic alternatives, FDA Commissioner Scott Gottlieb said in a statement. It is unclear how much the generic product -- manufactured by Teva Pharmaceuticals -- will cost. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600. The price of two EpiPens was about $100 in 2009. The brand name version is by far the most popular epinephrine auto-injector on the market. "This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," said FDA Commissioner Scott Gottlieb in a statement.
How...soon...can...I...get...it (Score:1)
Need....it.....now
Yahoo! Epi For all! (Score:3)
Generic of course.
I'm just curious, why are Epi Pens not already generic?
Then observe the value of competition... The market works, if you let it.
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Greed.
Any other questions?
Re:Yahoo! Epi For all! (Score:5, Insightful)
Natural monopoly by the incumbent.
Generic: "Hey, we could make generic Epipens for about $100 each. The brand name costs $600. Let's sell them for $200 and undercut"
Incumbent: (Cuts price to $100. Eats small loss per unit)
Generic: (Goes bankrupt)
Incumbent: (Raises price back to $600, recoups losses)
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I don't see the point in having emotions towards it, since it has never exhibited and likely never will.
*laughs in patentsystem*
Re:Yahoo! Epi For all! (Score:5, Informative)
Also, if this were a common and accurate portrayal of events, why am I able to buy generic versions of many other types of drugs and medications? Shouldn't this have happened in ever other instance as well?
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I think you're forgetting the part where the government forbids the sale of the generic completely. As has been the case up until now.
I think you're forgetting that someone has to decide to make a generic and apply for FDA approval first.
Companies look at the natural monopoly and Mylan's anticompetitive history, and don't start the ball rolling on making one.
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why am I able to buy generic versions of many other types of drugs and medications?
Pills are relatively cheap and easy to develop. Mix drug with already-approved filler and you're basically done.
Autoinjectors are more complicated and require more FDA approvals, since it's both a drug and a medical device. That means longer R&D time and R&D cost, which makes it easier for Mylan to harm the competitor much more than Mylan.
Plus, Mylan has been significantly more aggressive on pricing than other companies, so the assumption has been they would be aggressive here too.
Re:Yahoo! Epi For all! (Score:4, Informative)
Generic: "Hey, we could make generic Epipens for about $100 each. The brand name costs $600. Let's sell them for $200 and undercut"
Incumbent: (Cuts price to $100. Eats small loss per unit)
Generic: (Goes bankrupt)
Incumbent: (Raises price back to $600, recoups losses)
Except your price estimates are a bit off. Experts say the actual cost of manufacture to Mylan is likely only $20 to $30 per pen.
http://time.com/money/4481786/how-much-epipen-costs-to-make/
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Actually, there is less than $1 of epinephrine in each Epipen.
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That's not manufacturing costs
And what do you imagine that manufacturing costs of this glorified syringe actually are?
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> Actually, there is less than $1 of epinephrine in each Epipen.
That remark would be relevant if you were only getting the drug. Since you aren't just getting the drug but also the delivery system, that remark is utter nonsense.
This is precisely the kind of inane bullshit that completely pollutes discussion of this issue.
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Actually, there is less than $1 of epinephrine in each Epipen.
It is relevant in any case. It is a statement of fact. You come across like you have a vested interest.
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Actually, there is less than $1 of epinephrine in each Epipen.
It is relevant in any case. It is a statement of fact. You come across like you have a vested interest.
Wow, somebody is systematically going through and modding down this factual information. Paid to do it, I assume.
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Actually, there is less than $1 of epinephrine in each Epipen.
Modding it down does not change the fact. What kind of subhuman does it take to do that, with millions of at risk children unable to pay the ransom?
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Epipens cost $100 each in Australia (that's $72USD). And that's without funding. Epipens are listed on the Pharmaceutical Benefits Scheme so if you actually need them rather than just buying them off the shelf you get them with a doctor's prescription for $38 ($27USD)
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Do you need me to link the definition of "example" for you?
Re:Yahoo! Epi For all! (Score:5, Informative)
Jeebus, I can understand not knowing how the process works, but really you can't make it past the damn headline without incorporating the relevant information ?
FDA Approves First Generic Version of EpiPen
That is why there was no generic on the market, none were improved. Now if you want to go poking fingers about how horrible the system is, the CEO of Meylan (Heather Bresch) is Joe Manchin's daughter and oddly enough the FDA has been curiously well disposed towards his little girl's company
http://fortune.com/2016/09/07/... [fortune.com]
Oh and he's a Democrat by the way, something to remember the next time they promise free healthcare.
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improved should read approved.
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Oh and he's a Democrat by the way, something to remember the next time they promise free healthcare.
I have never seen anyone (sane) promise "free healthcare" since there is no such thing. What they promise is healthcare for everyone. You know, like every other civilized country on the planet. We SHARE the cost and make it available to all without bankrupting the less wealthy among us in the process. Heaven forbid we share the costs and give a shit about our fellow citizens.
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The FDA doesn't just approve generics that do not exist yet. Someone has to decide to make a generic, and then seek FDA approval.
With Mylan's anticompetitive history, anyone wading into this space knows that Mylan will slash their price to drive the generic out of the market. So no one decided to lose a giant pile of money developing a generic.
This particular company is betting that Mylan has attracted enough scrutiny that they won't be able to do it without antitrust regulators going after Mylan. We'll
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Here's the history of the product
https://www.businessinsider.co... [businessinsider.com]
maybe you should acquaint yourself with the facts before going off on these matters ?
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Oh and he's a Democrat by the way, something to remember the next time they promise free healthcare.
He almost always votes with the Republicans though.
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The issue with the last step is that another company can threaten to restart the cycle
That threat has to be credible to be effective.
We're not talking about something easy-to-make like a pill. An autoinjector is significantly more complex. So higher R&D costs, as well as more FDA approval work.
So another company saying "we're gonna come get you" is not as much of a threat because it's going to take that company longer to develop and get approval for their version. That gives Mylan plenty of time to react and thus cause far more damage to the generic than to their business.
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Who could attribute the high price to the government completely forbidding competition in view of this totally not bullshit explanation.
The government did not forbid competition. Anyone could develop a generic, get it approved and sell it. For decades.
Mylan's anticompetitive history caused companies to decide that losing a giant pile of money developing a generic only to get crushed by the incumbent was not in their best interest. The government's role is a relatively minor increase in development cost.
Re:Yahoo! Epi For all! (Score:5, Insightful)
In part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
Then you get overly specific legislation like when schools are required to have $600 epi-pens on hand rather than $10 pre-filled with epinephrine syringes.
Re:Yahoo! Epi For all! (Score:5, Informative)
part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
As someone who has done this repeatedly, I can tell you that proving equivalency is an order of magnitude cheaper than proving a new design.
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Actually, the FDA came about to say you can't just put any old crap in and call it medicine. Specifically, diethelyne glycol in in a children's Elixir Sulfanilamide formulation. Then it said you couldn't just go giving untested drugs to pregnant women such as thalidomide.
It does seem to have jumped the shark since then, but that is a call to reform (literally) the FDA, not eliminate it categorically.
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No, it pretty much comes out on it's own. Why, are you soliciting for employment?
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I think you could get generic epinephrine auto injectors prior to this.
Epi Pen is a (tm) so how you can have a Generic Trademark is puzzling.
About the only non puzzling thing about pharmaceuticals is the chemistry.
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Why do they charge $600 for an EpiPen? Because they CAN!
Only because they are the only ones supplying them. I say we encourage generic makers to enter the market and fix that issue.
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Wasn't there a threat/article about "capitalism" a few days ago on /. .... ?
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EpiPens are not already generic because every time you change the delivery mechanism, you restart the patent timer. Yeah, they made a minor change to the mechanism to keep it patentable. How that prevents competitors from using the old mechanism is beyond me.
Then, wouldn't the previous delivery system come out of patent and generic manufacturers be enabled to make them? There has got to be more to this.
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That's not how any of this works.
After a patent expires, the specific things covered by that patent become free to use. That's the whole point of the system.
There's no law requiring one to patent all methods used in a device all at once: You can't *force* someone to patent something.
There's also no law preventing one from patenting methods later down the road: The invention doesn't have to be new or previously-unseen to be patentable. It just has to pass the usual muster for a patentable thing. If that
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Read the article. These new ones are not really actually generic either. It's still Mylan screwing over customers. They are simply changing the branding and the branding only and charging less, not a lot less though. It's still going to be about $300 for 2 pens...
They are doing this in a really shitty attempt to save face. It's not going to work.
Your question is a valid one, why is there not a generic? Also, why is another company not creating a generic. This is no different than Chevy vs GMC. The s
Car analogy fail. (Score:1)
This is no different than Chevy vs GMC. The same fucking truck, same features, same materials, built on the same assembly lines, but with different logos and different costs.
I can pretty much guarantee the costs are (exactly) the same. Why are there identical Chevy and GMC (and Cadillac Escalade) trucks? Marketing!.
GMC and Cadillac dealers (usually*) don't sell Chevy. So when a trucking company is buying 50 big trucks but also wants one or two or twenty pickups, the GMC dealer has GMC brand pickup trucks to sell. When traditional Cadillac buyers started buying Chevy Suburbans, and Cadillac dealers had nothing to sell, GM invented Cadillac Escalades for Cadillac dealers to sell.
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Teva is an Israeli company. As far as I can tell, it has no links to Mylan. If you know differently, care to share?
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Generic of course.
I'm just curious, why are Epi Pens not already generic?
Then observe the value of competition... The market works, if you let it.
There is already a generic epinephrine injector that's been around for about 13 years called Adrenaclick. I bought mine from Walmart for about $160, I think.
There's also the Auvi-Q since 2012. https://www.drugs.com/history/... [drugs.com]
https://www.consumerreports.or... [consumerreports.org]
https://www.usatoday.com/story... [usatoday.com]
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Generic of course.
I'm just curious, why are Epi Pens not already generic?
Then observe the value of competition... The market works, if you let it.
Drugs become "generic". EpiPens are a patented, approved, and proven simple and reliable drug delivery system.
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The drug (Epinephrine) is generic and the amount in an EpiPen costs under $1 at the pharmacy. It's super cheap and super available.
The part that's patented is the "auto-injector" part. You know, the bit that you jab into your leg and it injects that drug into you. And that's the part they pumped up the prices up on even though it's probably made up of plastic and
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Mylan has patent protection that lasts through 2025. So why is a generic version coming to market now?
Mylan to launch generic version of EpiPen, at half the cost [statnews.com]
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Because the patent is on the device itself. The drug is generic and has been for many years (hint: you can buy it super cheap - the dispensing fee probably costs more than the drug itself).
If you don't do what the patent says, you can get a new patent on your auto drug dispenser.
Re:Bobbied is a moron. (Score:4, Informative)
Because they existed before 2009, but Mylan changed the design slightly around then and reapplied for a patent on the "new improved" design.
This generic can be exactly the same as a pre-2009 model and still work just fine.
Nationalising Medicine (Score:1)
(Re-)Nationalisation is what happens to industries that devolve into an orgy of obscene rent-seeking.
We need more of this sort of thing to scare the bejesus out of MBAs who have grown docile on a generation of Reganomonics and plant media support.
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[AC to preserve moderation]
Medicine does not fear socialism. It's just another set of government regulations they can capture and use to keep their monopoly going. What medicine really fears is capitalism, which is why you never see international competition, the process that makes everything else we buy cheaper, mentioned as a solution to high prices.
Sucks to be in USA (Score:3, Informative)
Genuine brand named EpiPen's in New Zealand are $NZ120 each. They never skyrocketed like they did in USA.
The government usually replaces used epipens too, as everyone here is covered medically for accidents and anaphylaxis is usually caused by an accident.
Can you even buy Anapen's in USA? They're an alternative available in most countries. They've been around since 2010.
Re: Sucks to be in USA (Score:1)
a pack of 2 epipen autoinjector costs about 50â here in finland
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There are alternatives, but the prescription must state "epinephrine auto-injector", not "EpiPen" - if EpiPen is written, the other cannot be delivered, even if the prescription states that generic substitution is acceptable. I believe this is because it is a device rather than simply a drug.
A vial of epinephrine containing two doses is $5 USD. Often a syringe costs more than the drug.
However the syringe method needs careful attention to dosage amounts.
Less of an issue is properly injecting it, fortunately being intramuscular makes that easier, and training is readily available, but if you are administering it to yourself vs administering to someone else, that's still a couple details in the middle of an allergic reaction that need paid attention on.
Epipen and similar devices are supposed to m
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That's not how this works.
In the US (in all states I'm aware of), a doctor can write a script for Celexa and the pharmacist can fill it with generic citalopram, *unless* the doctor specifies that the name-brand product be used.
Normally, on hand-written scripts, this is signified by the notation DAW, which means "Dispense As Written."
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So? (Score:2)
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Our current government is run by a bunch of leftie vote buyers.
They bought their way into power with free university education and a bunch of other policies they are now realising can't be funded.
One of those vote buying policies was making it harder for foreigners to buy residential property, because they did a survey of people at some house auctions and there were a lot of "Asian sounding names" - so they're blaming foreigners for our high house prices.
Anyone can get medical assistance for accidents here.
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Our current government is run by a bunch of leftie vote buyers.
They bought their way into power with free university education and a bunch of other policies they are now realising can't be funded.
One of those vote buying policies was making it harder for foreigners to buy residential property, because they did a survey of people at some house auctions and there were a lot of "Asian sounding names" - so they're blaming foreigners for our high house prices.
Anyone can get medical assistance for accidents here. I doubt there are many firmware engineer jobs though.
https://www.immigration.govt.n... [immigration.govt.nz]
I'd like to highlight this point. To anyone thinking of coming to New Zealand: Yes, it's looking pretty good right now, but the fundamentals of civil society (innocence until proven guilt, free speech, mens rea, financial privacy) are under heavy assault as a people that like to joke about how bad the US is simultaneously swallow all the legislation the US exports to them. New Zealander's are absolutely not the kind of people that will stand against oppression, they're more laid back (read: cowardly and o
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> What do I need to do to get residency in NZ so I can buy a house there?
You aren't rich enough to buy a house there.
Before you decide to relocate yourself to a place, you might want to actually get somewhat of a clue about it. You don't even have to visit. You can simply read the local press.
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> What makes your think Orange Julius Caesar had anything to do with this?
This didn't happen during the administration of your lord and savior.
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This is also the first thing that the FDA has done right in the last decade. It's a small step in the right direction anyway. Still doesn't restore my trust in the organization though. Getting rid of GRAS would go a long way to healing a lot of open wounds.
I'm not advocating you trust the FDA, but I wonder why you think getting rid of GARS would be a good idea?
Generally speaking (pun intended) GARS may not have been subject to the rigor of other additives, but they DO have significant amounts of research, study and actual use history that indicates they are indeed safe for use. So which substances on the GARS list do you object to? Whey? Helium? Nitrogen? Maybe Citric Acid or Nitrous Oxide? Something else?
Why do you object to these specific things?
Re: The only thing this administration's done righ (Score:2)
Good news! (Score:1, Interesting)
Now this needs to be approved for Canada as well... Not only are they super expensive, they aren't even in stock! We are seriously experiencing Shortages on EpiPens up here it's ridiculous.
Win the battle, lose the war (Score:3, Insightful)
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and no one talks about what is really needed in the US: the government as the only buyer of drugs. If drugs are such that there is only one supplier, with patent protections that give a monopoly on production, there should be a single buyer, that would negotiate an acceptable price, and then this buyer sells to all pharmacies at cost, which leads to an equitable distribution.
Because that works so well at cost reduction for other things the government is the sole buyer of, like military equipment?
"Popular" (Score:4, Insightful)
It's not like Mylan raised the price of their epipens to 600 bucks because they're the Apple of EpiPens here. People either had to cough up the cash or die. Consider that an EpiPen costs $30 to manufacture. [time.com] (yeah yeah sure, there's shipping costs and the like. But I'm pretty sure they weren't using SpaceX to ship their EpiPens from Pensylvannia, to the rest of the US)
Re:"Popular" (Score:4, Funny)
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I don't think Epipen injectors are like my Albuterol inhaler that the generic doesn't work worth a damn, but the name brand one works every time. My doctor writes "no generic" on my prescription each time, but the pharmacist at my local Rite Aid every time still tries to push the generic.
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It's great fun when a powerful senator is your dad and can lean on the FDA.
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I can appreciate those of us who aren't helpless helping out those who genuinely are. However, there is no reason for those of us that are independent adults who can fend for ourselves to be wards of the state. We are not children. Not only should we be able to fend for ourselves, we should be able to help fend for others.
Beyond that, if you want the likes of Trump, Cruz, and Ryan to have MORE control over your health care you are simply nuts.
If you are looking for some kind of "bargain" then all you are go
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You can't suck money and resources out of the system and expect the same results.
Of course you can. All you have to do is say the results are the same or better, then to your supporters that's the new reality. Whether they actually are is immaterial, since anything contradicting your narrative is just Fake News. Lying enemy of the people? Fake News. Congressional Budget Office? Fake News. Congressional Research Service? Fake News!
Now do Insulin (Score:4, Insightful)
Apparently Insulin has shot up in recent years. It seems crazy it should cost much at all, it's been made forever...
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Not forcing anyone (Score:2)
It's not forcing anyone to "make drugs at cost", it's allowing more than one company to make especially widely used drugs - for drugs that have been around a very long time, thus profits have been long recovered for R&D.
The whole intent behind patent and copyright systems is that eventually everyone gets to make use of inventions, so too should be true of drugs.
Basically, it's just allowing competition where before there was none. Doesn't get much more American than that.
First generic? CVS is already there (Score:2)
CVS has been selling a generic version of the EpiPen since the beginning of 2017.
https://www.pharmacytimes.com/... [pharmacytimes.com]
free market ftw (Score:1)
Free markets accomplish things, people.
I have been suffering from (HERPES) disease (Score:1)
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Should a cup of Starbucks cost a quarter?
No, but if you'll die if you don't get one, then it shouldn't cost $600.
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Wait... you mean all my coworkers aren't serious about dying if they don't get their Starbucks in the morning???
Ask them for the hospital bill as proof, I can show you mine.
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> No, but if you'll die if you don't get one, then it shouldn't cost $600.
That will be a fun way to ensure that nobody ever makes anything useful for you EVER.
$600 really isn't that much in this area really. You clearly have don't have enough real experience here to have ANY sort of perspective at all.
Attitudes like yours ultimately kill people.