
FDA approves first generic version of EpiPen - MBCook
https://www.washingtonpost.com/news/to-your-health/wp/2018/08/16/fda-approves-first-generic-version-of-epipen/
======
forkerenok
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...](https://www.washingtonpost.com/business/economy/2016/08/25/7f83728a-6aee-11e6-ba32-5a4bf5aad4fa_story.html)

~~~
da_chicken
> 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.

~~~
mikeyouse
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...](https://www.amjmed.com/article/S0002-9343\(10\)01087-9/abstract)

~~~
mjcl
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.

~~~
chimeracoder
> 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.

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

------
pg_bot
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.

~~~
pkaye
> 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.

~~~
pg_bot
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.

~~~
pkaye
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...](https://www.npr.org/sections/health-
shots/2017/07/18/537257884/that-drug-expiration-date-may-be-more-myth-than-
fact)

------
MaxGabriel
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).

~~~
Johnny555
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.

------
jly
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.

~~~
maxerickson
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...](https://www.goodrx.com/adrenaclick?drug-
name=adrenaclick&form=package&dosage=2-auto-injectors-
of-0.3mg&quantity=1&days_supply=&label_override=epinephrine%20\(Adrenaclick\))

------
uberduber
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.

------
MrBingley
> 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.

~~~
amluto
Is Adrenaclick available in Canada?

------
joezydeco
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.

------
jschwartzi
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.

~~~
Symmetry
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.

~~~
cryptonector
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.

------
smokelegend
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...](https://www.google.com/amp/s/www.technologyreview.com/s/602422/it-
costs-30-to-make-a-diy-epipen-and-heres-the-proof/amp/)

~~~
blacksmith_tb
Recently on HN, too:
[https://news.ycombinator.com/item?id=17629436](https://news.ycombinator.com/item?id=17629436)

------
ChuckMcM
And then there is this:
[https://www.nytimes.com/2018/02/24/us/politics/pharmacy-
bene...](https://www.nytimes.com/2018/02/24/us/politics/pharmacy-benefit-
managers-gag-clauses.html)

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

------
russdill
I'll just leave this here
[https://www.bloomberg.com/news/articles/2018-04-24/generic-d...](https://www.bloomberg.com/news/articles/2018-04-24/generic-
drug-companies-said-to-face-first-charges-in-u-s-probe) (Teva and Mylan)

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

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

[http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-
dr...](http://slatestarcodex.com/2016/08/29/reverse-voxsplaining-drugs-vs-
chairs/)

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

~~~
ksherlock
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.

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

