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FDA approves first generic version of EpiPen (washingtonpost.com)
319 points by MBCook 6 months ago | hide | past | web | favorite | 82 comments



From the article

> Other epinephrine injectors have been approved before, but they struggled to gain market share against a brand that used lobbying and marketing to establish a virtual monopoly on the market.

This got me thinking that consumers are at fault as well. But then I read the following from the linked article[0].

> “Their most brilliant maneuver, clearly, was giving them [EpiPens] away to schools and making it the thing that they could say, ‘Well, the nurse knows how to use it,’ ” said R. Adams Dudley, a pulmonologist at the University of California at San Francisco. “What are the parents afraid of? Their child will be away from them, and they won’t be there to use it. If they can say the school nurse knows how to use an EpiPen; she’s never seen an Adrenaclick ... It’s just a fear thing.”

With such (understandable) absolute risk averseness what is the way out?..

[0] https://www.washingtonpost.com/business/economy/2016/08/25/7...


> This got me thinking that consumers are at fault as well.

It's also partially the doctors. If a doctor writes a prescription as "EpiPen," then the pharmacist has to provide a drug with the brand EpiPen. The doctor has to specify "EpiPen or generic equivalent" on the prescription in order for the pharmacist to be able to fill it with a generic. If doctors don't realize that EpiPen is a name brand -- and "EpiPen" is so ubiquitous as to be nearly genericized at the point -- then doctors may not realize the issue.


This isn't typically true -- If a doctor writes a Rx for Lipitor, it'll almost never be filled with the Brand Name Lipitor. All insurance and most formularies expect that the generic will be provided. Doctors have to write "DAW" or "Dispense as Written" on the Rx for the patient to receive the brand name when a generic is available.

AJM Confirming that all states have Generic Substitution laws to lower drug costs: https://www.amjmed.com/article/S0002-9343(10)01087-9/abstrac...


This is the whole point of the article btw : there have been "non-Mylan" EpiPen products on the market in the US for the past year (that are low cost) but they aren't magically associated with the SKU "EpiPen" in the Pharmacy -- you have request them by name. This news is about an alternative autoinjector being approved for that special "Pharmacist can substitute for the real thing regardless" status.

Source : son with severe peanut allergy and insurance that doesn't cover epipens. Made several trips to Canada (for other reasons); bought Epipens there for us and various friends.


But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.


> But to date, delivery devices like the adrenaclick have not been considered equivalent to epipen. Some states permit a substitution in these cases (a 'BX' rating instead of 'AB'), but many do not allow it without getting clarification from the prescriber.

Because, unlike the generic version described in the original article, none of those were generic versions of the EpiPen. They were alternate delivery systems.


Some of the ones pulled in 2007 or 2008 were generic versions of the EpiPen that existed at the time.


But you can only do that if the FDA has said the generic is a perfect substitute, which hasn’t happened on any previous substitutes. This device is the first one to get that label.


Correct, a drug has to be listed as "AB rated" in the FDA Orange book in order to be substituted automatically for the branded version.[1]

AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements

Andrenaclick is "BX rated".[2]

BX Drug products for which the data are insufficient to determine therapeutic equivalence

The new generic version from Teva is "AB rated".[3]

[1]https://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm0790... [2]https://www.accessdata.fda.gov/scripts/cder/ob/results_produ... [3]https://www.accessdata.fda.gov/scripts/cder/ob/results_produ...


Every prescription I've received in the last several years had two signature lines. If the doctor signs on one, it's "dispense as written", and if they sign the other it's "substitution permitted". So it's not like they have to do something special to get DAW.


But how many of the prescriptions you received had the signature on the DAW line? It's typically very uncommon.

In fact, in the hospital setting, a portion of a Physician's reimbursement is tied to the ratio of generics to brand name drugs that their patients were given.

I'm not sure if this is the case for outpatient stuff, but internists are absolutely incentivized to prescribe generics.


None, but that's not the point. I was just saying that there's not an extra hurdle to prescribe DAW like you were implying.


A pill is just a pill, and the FDA accepts many generic drugs as substitutes for the name brand version. But an epipen is not just an epinephrine injector it is, itself, a medical device, and until now your prescription for an "epipen" wouldn't allow you to get a substitute device.

Consider the scenarios here. How would someone get a prescription for a non "EpiPen" epinephrine injector? They would have to be very savvy with access to a doctor as well as incredibly price conscious. They would have to convince their doctor to write a prescription for a specific other device. All of which is a very unlikely chain of events.


As I understand, Epipens have a specific legal exception to this law. Epipen prescriptions are not valid for, say, adrenaclick injectors.


I worked at a pharmacy in the US for 8 years. This is simply not quite true, and your telling of it paints a picture that is different from reality.

Doctors have to specify when writing a prescription if an generic is acceptable or not. It is always a deliberate choice with each and every prescription. There is no "Just forgetting." Paper prescriptions, for example, have two different places for signatures. Most doctors know that insurances often require generics.

There are good reasons not to substitute for some medications: Lithium (common for bipolar disorder), for example, sometimes absorbs differently between brands. Even with drugs that have no generics, most doctors will write a prescription saying that a generic is acceptable in case one has been approved without their knowledge. Doctors really only need to know when there are differences with generics vs brand names.

Not only that, but if the doctor requests the brand name, most pharmacies will call the doctor to see if they can switch to a lower-cost generic if the patient requests it. This is done a lot, sometimes simply because the patient doesn't realize the medicacation costs when they are at the doctor's office - they often don't realize the costs until the pharmacy runs the prescription through their insurance.

The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.


I know there's always at least one non-US resident that pipes into these threads with the same generic comments. But I can't help but be 'that guy' this time.

> The same is true if the doctor prescribes something not covered by a patient's drug formulary: some insurances require folks start off with x or y drug and only give special acceptance to drug z if they've tried the other drug.

The U.S. private health insurance system is so weird.


It is, though! I'm in Norway now, and trying to explain the US healthcare generally leaves folks a bit flabbergasted. I am quite happy that I'm no longer in the states - state-sponsored medicine is much simpler and less stressful to deal with.

And to make it weirder: The formularies are generally based on agreements the insurer has made with the drug companies and/or pure cost of medicine if there was no deal to be made. I'd not mind some generally accepted standards in treatment based on patient outcome, so long as the patient doesn't have factors that change the standard treatment, but long-term outcome and cost over time doesn't seem to be the focus. This is likely due to many folks not keeping the same insurance long-term.


It's likely that whatever healthcare system you access has some list that serves a similar purpose. Wikipedia lists some of them:

https://en.wikipedia.org/wiki/Formulary_(pharmacy)


It’s so ubiquitous in fact I’d say it should probably forfeit its protection as a trademark. Same as fax machine, cell phone, etc.


In Australia, the prescription is assumed to allow generics by default.

Whenever you go to get your script filled, the pharmacist will ask "would you like a generic?"

https://www.humanservices.gov.au/sites/default/files/images/...

If you look at the above form box #10 - there is a box a doctor will tick if there is a specific reason not to substitute. In that case the pharmacist will not be able to give you a generic version. But that generally is an exception and not the norm.


That's ridiculous. In my country, it is the law that prescriptions are named by substance/generic name rather than a commercial name, and come with a text saying "You will spend no more than X if you buy a generic.". The pharmacist also must give you the cheapest generic unless you specifically request another.


I've had pharmacist question a prescription because it was a brand name. It was going to cost 250 dollars with insurance. She called the doctor and got the equivalent prescription and it cost 10.


This is not true. Doctors actually have to specifically state that substitution is not allowed; otherwise pharmacies will fill with generic.


Doctors are well aware. But pharma reps treat them well and give them perks so that they don’t write generics. It’s a big kickback scheme.


There are at least two other products on the market and they are easy to use. Just quit buying epi pens. Tell your doctor/school you won't be using it and deal with it.


What are some other alternatives? "Just quitting" EpiPens would be awesome if there were some known alternatives for those who need them to live.


Not to be rude, but in the time it took you to write this comment you could've just typed "epipen alternatives" into Google.


The school may not want to accept that...


Whatever medicine I give the school to administer to my child at the appropriate times has to be observed; the school cannot wantonly withhold the medications I provide them, especially when provided a Dr's note.

If I send my child to school with an "off-brand" epipen with a doctor's note and direct the school to use this instead, they have to observe it -- a nurse is in no way capable of making a drug administration decision without the consult of a licensed medical doctor.


But what if they fuck it up and your kids dies? That's the (not totally irrational) fear - parents want the nurse using something they are already familiar with.


If the school nurse is that incompetent you have bigger problem


I don’t think an incompetent school nurse would be a bigger problem to me than my child dying.


The bigger problem is how many other children receive substandard care.


In England the protected title is "Registered General Nurse" or "Registered Mental Health Nurse" - a registered nurse is qualified to a certain standard and has a professional registration.

Nurse isn't a protected title, so it's possible a school nurse has minimal qualification and no professional registration.

I dunno if it's similar in the US.


I had an EpiPen and various other stuff when I was in 5th grade. I was taught to use it. If a nurse is incapable of administering it properly that person needs to find a new line of work.

It honestly is a completely irrational fear.


Or they fuck up, prick themselves with epinephrine, and die (or at least not have a very good time).


There is no monopoly. Many other epi autoinjectors have entered the market, and were withdrawn - or have clung on without many people know they even exist...

People forget there is also a human factors element:

If the pen is not easy to use, it could lead to an inability to deliver the medication simply because the person can't read the directions while their airway is closing up.

For instance: 1 pen on the market now has a speaker built into the pen which gives voice directions for anyone to be able to administer a dosage to someone who needs it [0].

If the pen mechanism itself is not robust, and delivers inadequate or overdosages - then this is also bad, and is also where other competitors have failed [1].

The EpiPen itself is actually a bit of a work of art because it gets most of these things right on - this is why they've dominated.

0 - https://www.auvi-q.com/ 1 - http://www.twinject.com/


EpiPen was literally granted market exclusivity by the FDA, there was a government enforced monopoly on the particular mechanism, one which was granted on what, as far as I can tell, was a superficial improvement to the safety cap.

Mylan continues to try to restore their exclusive rights.

https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.c...


I think you are misunderstanding "Market Exclusivity" vs. monopoly: Yes the EpiPen mechanism is patented, and people cannot knock it off directly - this is not a monopoly, because competitors have been allowed to create new designs for a long time. [1]

The fact that Auvi-Q, TwinJect and many other Epi-autoinjectors are allowed on the market as New Drug Applications (Non-generic) shows us that the FDA has allowed healthy competition from other Autoinjector designs -- they simply have not been as effective, safe or simple to use, leaving EpiPen as the standard.

1- https://www.fda.gov/drugs/developmentapprovalprocess/ucm0790...


Yeah, thanks for telling me I misunderstand it.

It's not an economic monopoly, but (at least in the case of the EpiPen) it's bad regulation with similar impact.


How much are school nurses in the USA still a thing? I had read recently that many schools have done away with nurses for cost-saving reasons. Instead, there is only one roving nurse for an entire set of schools or the whole district.


This was my experience throughout my K-12 education and I graduated in 2010. Every time I was sick or injured the nurse was at different school, so they'd just send me home. The only exception was when my gym teacher suspected I had a concussion and the nurse drove from another school to examine me.


They sent you home because they didn't want to be responsible for your health/safety.


My local school district has about three schools per nurse overall, but the ratio is a bit different between elementary, middle and high schools. One of the largest parts of their job is training the TAs and other school staff to administer the medications their students need, because it's far too big of a job for the nurses to handle. Our local government has made a halfhearted attempt to fund a new school nurse position for every new school they build, but it hasn't been working well so far.


> This got me thinking that consumers are at fault as well.

When is this ever the case? Especially when the decision results in a comparative loss?


The same strategy used by Microsoft, Mathworks, and drug dealers: Get 'em hooked and you'll have a customer for life.


The way out is for these companies to also educate the public about how to use their autoinjectors. If the half dozen medium-small companies who marketed the EpiPen managed it well before Merck got involved, surely almost anyone else can do the same (if they are not too lazy to do the basic due diligence).


While there are other epinephrine auto-injectors on the market (auvi-q and adrenaclick) the big difference here is that this is considered a "generic" version of the EpiPen. The significance is that pharmacists can recommend that a prescription for an EpiPen be replaced with this, where they cannot with the others on the market. I will also note that the cost of the EpiPen is not due to the drug, it is the patent on the auto-injector which is set to expire in 2025. If you wanted to actually improve this product, you would follow the SpaceX model and allow replaceable cartridges for the auto-injector instead of throwing away the entire housing when the medicine expires every 18 months.


I agree with your bit about prescriptions. However I don't think following "the SpaceX model" would be very useful (or even a good idea) here. A few reasons: 1) the housing and needle are dirt cheap to manufacture, and as you said, it's the patent that is expensive and replaceable cartridges wouldn't get around that 2) much of the safety of these things is the clear labeling around expiration and such 3) the risk of improperly replacing a cartridge far outweighs the benefit of reusing a bit of plastic 4) you could only replace un-used epi-pens, as replacing the needle sounds dangerous


> allow replaceable cartridges for the auto-injector

I think the risk of reusing injection equipment is chance of infection. Also a more reasonable solution to the wastage is to do a long term study to extend the expiry date. The drug manufacturer don't do a long study because of the lost time plus potential extra sales.


I am still for single use, but if it is unused and the medicine expires people throw away the entire thing. The reason for replacement every 18 months is that the medicine expires, if you could just replace the medicine if you didn't use it you may see cost savings. However, I am just spitballing here and it is likely that there are reasons why this cannot come to fruition which I have not considered thoroughly.


Most of the cost is just the patent exclusivity plus paying for R&D/testing. If someone invents a new mechanism it will have to start over again and will stay expensive for another decade or two.

The simpler thing is do enough testing to extend the life of the current solution to 3-5 years. The manufacturer will have no incentive to do that unless there is some competition.

https://www.npr.org/sections/health-shots/2017/07/18/5372578...


As far as that goes, we have a long line of safety for this. Many other approved injections for home use have replaceable cartridges. These cartridges often include the pre-measured dose along with a sterile, new needle.


> and allow replaceable cartridges for the auto-injector

A good idea, but also possibly a point of failure (by the end user) in an emergency. Epipens come in pairs for these rare, but possible, occurrences.


The anaphylaxis action plans we've received have all called for a second injection shortly after the first if no improvement is observed. I suppose that could be because most people will have 2 injectors on hand and docs know it.


>I will also note that the cost of the EpiPen is not due to the drug.

Spot-on. I remember when I was doing my anesthesiology residency and I asked the guy who ordered drugs for our department what a 1cc vial or ampoule of epinephrine (an auto-injector delivers precisely that amount) costs; he replied (this was the late 1970s, mind you), "About 10 cents." Even allowing for inflation, I can't imagine it's more than $1/dose today.


Looks like king county is getting them for $9/dose:

https://www.jems.com/articles/print/volume-42/issue-6/featur...


I talked with a Pharmacist a few months ago about the cost of epinepherine, and a 10 dose bottle was $6.


I must say I'm surprised this drug is available in a multidose bottle because of the potential for contamination. I've only ever seen it — in many hospitals large and small, in both California and Virginia, over the past 40 years — in 1cc bottles and ampoules. That is and has long been the default adult SQ and IM dose. In STAT situations it's given IV or, as a last ditch measure attempting to reverse cardiac arrest, via direct intracardiac injection using a long needle.


Or we could reform patent laws. Asthma inhalers are currently egregiously expensive because a change in law prohibited out-of-patent inhalers over the tiny amount of CFCs they contained.


Yes, the EpiPen was first marketed in 1987. It would be quite interesting to see an evaluation of all the patented improvements that have been used to keep alternatives off the market.


A good next step would be to make it easier to buy the injectors. In California, if you’re not a medical professional, you need a first aid and CPR course to buy one. This is for a device whose commercials consist of six year olds explaining how to use it, and one that can be life-saving if someone has an allergic attack in the backcountry (where lots of previously unknown attacks happen, because of unusual foods/insects).


Requiring some base level of medical training sounds reasonable... Epinephrine injections can have dangerous side effects, so making sure the person with the pen knows when to use it sounds like a good policy.

If you're worried about backcountry safety, taking a first aid class is probably more useful than carrying an epipen.


This step makes sense. Random first aid person carrying an injector without proper knowlege on how to use one seems a bit... short-sighted.

Sure, those 6-year-olds know how to use them because they've been trained on how to use them. So have their caregivers. Usually this is because they might need to use one on themselves, a sibling, or a parent - who has a known condition.

The random person that doesn't come in contact with such a relative or housemate, however, might not even properly recognise the reaction. Even when they do, they still need the training on how to use the pen so they know how to respond. The prudent thing to do in these cases is to give a first aid and CPR course to those that wish to have one.


The cost of the non-Epipen / generic auto-injectors are still very high. Usually at least $109 for a 2-pack, from what I can tell, and often $200+ in some places. How much will these cost without insurance? Sometimes there are coupons available from the manufacturer, I guess. But why should I need to jump through these hoops? These injectors lose efficacy over time and need to be replaced regularly for those that need to have them available for a severe allergy.

Epinephrine costs maybe $5 for a dosage. It's been sold for over 100 years. It's a WHO essential medicine for anaphylaxis, and is life saving for humans and pets. It's the same thing with other critical hormones like insulin.

The market for this stuff (even with generics) doesn't work. We know how much these drugs cost to manufacture and it's very little. Essential medicines with overwhelming human impact need to have strict pricing regulation that makes them available worldwide at close to the manufacturing cost.


GoodRx estimates cash prices (they are the PBM for the transaction, not insurance). They say $109 at a couple places:

https://www.goodrx.com/adrenaclick?drug-name=adrenaclick&for...


I've always had high-deductible insurance and for many years I specifically had allergists write me prescriptions for generic Adrenaclick. I've been to Rite Aid, Walgreens, Target, and CVS and they always magically fill it with a name brand Epi-pen. The pharmacy techs always refuse to fix it saying they can only fill it with the brand name. I have to insist on speaking to the actual pharmacist who apologizes, corrects the issue, and explains to the pharmacy tech how it works.

My physicians are writing the prescription properly. One year out of frustration I made my doctor actually write "Adrenaclick" and "may substitute with generic" and they still filled it with an Epi and the tech tried to argue with me that "Adrenaclick" was another word for "Name brand Epi-pen"

Last 2 years my allergist let me know Auvi-Q will give you them for free as long as you have any commercial insurance. They submitted the paperwork, I answered one call confirming my address and I got four Auvi-Q injectors in the mail the next day. Glad I didn't have to pay $100+ and argue at the pharmacy.


> This approval means patients living with severe allergies who require constant access to lifesaving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.

I live in Canada, and there are already drug shortages. You cannot buy any EpiPens in Canada. Period. For whatever reason, we are all out. I had an allergic reaction this week, and took a gamble to go the emergency room before the anaphylaxis really kicked in, because I only have one (expired) EpiPen left and want to save it until I'm really desperate. Each EpiPen costs $35 to manufacture,and I have no idea how a multi-billion dollar company like Mylan can have a manufacturing shortage of a life-saving drug, especially given their 17x (!) profit margin. I'm usually not a religious person, but I can only hope there's a hell so those corporate executives can rot in it.


Is Adrenaclick available in Canada?


IMO the AuviQ was a much better device. It was more compact and included audio instructions on how to use it. I'm glad to see someone is trying to bring it back.


Does this use the same autoinjector as the EpiPen? Because as I understand it generic epinephrine autoinjectors already exist, but they use a different autoinjector technology that isn't as easy to use as an EpiPen.

Edit: We talked about them when we were using the EpiPen trainers in the first aid class I took.


The main barrier to other auto-injectors, as I understand it, is that doctor's prescriptions for "EpiPens" couldn't be used to purchase them. With these that apparently isn't the case.


Mind you, the patient could ask for a prescription for the alternative products, and the doctor could suggest it. If the patient doesn't, it's probably out of ignorance. If the doctor doesn't... it could be ignorance too.


Just going to leave this here

It Costs $30 to Make a DIY EpiPen, and Here's the Proof - MIT Technology Review MIT Technology Review

https://www.google.com/amp/s/www.technologyreview.com/s/6024...



And then there is this: https://www.nytimes.com/2018/02/24/us/politics/pharmacy-bene...

The trick is getting people who need epipens to ask the pharmacist if they have the generic version available.


I'll just leave this here https://www.bloomberg.com/news/articles/2018-04-24/generic-d... (Teva and Mylan)


Ah, the beauty of the free market at work! This is an awesome accomplishment and I hope to see more things like this!


For anyone who wants a good background on why this is a big deal:

http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-dr...


Is this old news? I bought a generic epipen in 2016


Your generic EpiPen was actually a Mylan EpiPen with a different sticker and a slight discount. (but somehow cost 2-3 times what an EpiPen cost 5 or 10 years ago). This was manufactured by Teva and will provide actual competition to Mylan.


do we really need auto-injectors? what about a syringe that is administered much faster than a normal syringe? (slight distinction)




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