
FDA promised a ‘lower-cost option’ to EpiPen, but the price isn’t any lower - howard941
https://www.statnews.com/pharmalot/2018/11/27/epipen-teva-pricing-fda/
======
refurb
This article hints at it, but this is the _list price_ that nobody actually
pays. Manufacturers offer discounts to pharmacies that lower the net price.

So in fact, this drug could be cheaper than the Mylan version, but it looks
like they never dug in deeper to find out if it's true.

Second of all, the first generic approved gets 180 days of market exclusivity
whereby the FDA will not approve any other generic versions. This is such that
the generic manufacturer can recoup the investment prior to widespread
competition that drives down prices.

For example, Lipitor went generic and the price dropped only ~10-20%. After
the 180 days, multiple generic companies got approval and now the price is
80-90% lower.

~~~
aeturnum
Uh, sure?

The Mylan version will also probably cost less than list for most people
(though Mylan will get their money, just like the generic maker).

Also, you're correct that the price will come down over time. If the FDA had
said, "this approval is part of a process that will eventually lower the cost
within the next couple of years," then the article would make no sense. That's
not what they said when this generic version was released.

The article is not claiming that generic drugs don't reduce prices. It is
claiming that the narrative from the FDA, that this approval will reduce
costs, is largely false.

~~~
refurb
Yes, the article states that the Mylan product can be purchased for under $150
with a discount.

 _In fact, several large retailers sell EpiPen for $150 when including a
coupon, according to GoodRx._

As for the FDA narrative not being true, how do you know that? The article
doesn't actually state the true cost of the Teva product anywhere, which was
my original point.

~~~
yabatopia
$150 with discount or coupon is still way too expensive. Where I live in
Europe (Belgium) pharmacies sell the EpiPen for just $50. No need for a
coupon, that's the regular price. It's even cheaper for some patients.

~~~
Joeri
In belgium the government sets the maximum price of drugs. The drug company
has to submit a dossier explaining objectively why a particular price that
they propose is reasonable.

~~~
Communitivity
I think that is what we need in the U.S. When I was in college I survived on a
food budget of $100/week during my first year. I have diabetes, and I am
supposed to (though not required) test my blood three times a day, 21 times
per week, at $1 per strip. My Metformin costs me another $22 per week, and a
two other drugs costs me about the same. The result is that a single well-
controlled condition costs me $88 per week, $352 per month.

Put another way, if I was working minimum wage without insurance and no other
income (12% tax bracket), I'd need to work 13.6 hours to cover the drugs for
that one condition, 34% of my take home (roughly, I didn't include state tax,
social security, etc.). Where as one person I would have been above the
poverty threshold of $12.14k in 2018, now I would effectively be below it.

This is why so many people who don't have steady jobs (e.g., the gig economy)
have to choose between drugs and food.

------
Animats
A rule of thumb from the European Union is that it takes four competitors
before prices come down. Two form a duopoly, and it's to the advantage of both
parties not to lower prices. Four have trouble holding prices up. Whoever's
losing market share tends to cut prices.

Antitrust law needs to reflect the rule of four.

~~~
TheSpiceIsLife
Or, a government could just say:

If you want to operate as a pharmaceutical producer / seller in this country,
you have to supply this list of emergency medicines at 10% above the price we
can import from China / India.”

And be done with it.

Edit: fixed a typo

~~~
xvedejas
That's a good way to get _nobody_ operating as a pharmaceutical producer /
seller in this country.

~~~
TheSpiceIsLife
I mean, I'm talking about _maybe a few_ life saving emergency medicines.
Capping the price and allowing / encouraging / requiring other manufacturers
to sell in the market.

~~~
xvedejas
What availability would those producers need to provide? Some quota of
supplies? Low prices don't matter for much if there's a shortage, and there
_will_ be a shortage of cheap emergency medicine if the companies that produce
it can get away without spending too much on the unprofitable requirement.
(and if it were profitable they'd do it anyway, without need for government
requirement)

I worry that requiring a pharma company to provide supplies hurts anyone who
wants to start up a new pharma company. It's easier to comply with government
regulations once you're a big company and have many plants, but new companies
have to be lean or else they'll never make it off the ground.

~~~
TheSpiceIsLife
I don't have a wholly formed drop-in solution for the current problem, though
it certainly does seem there _is_ a problem.

No amount of _well-that-isn 't-going-to-work thinking_ is going to _help_.

Try _something_ , if that doesn't work _try something else_.

I believe the fashionable word is _iterate_.

~~~
marcoperaza
Society isn't some laboratory where you can run experiments to your heart's
delight. Decisions have consequences. Harming the market for medical research
is particularly insidious, as its costs are very real but hard to see: all of
the people who will be worse off because the treatments they need are not
invented.

~~~
TheSpiceIsLife
> Decisions have consequences.

Like, for example, the decision to increase the price of an Epipen to US$300
in the USA, whereas the same product in Australia costs AU$100

> Society isn't some laboratory where you can run experiments to your heart's
> delight.

In a way that's what _policy_ and _regulation_ are. Since we can't know the
full consequences of policy and regulation until they're implemented and time
passes. Sure, most policy and regulation aren't willy-nilly.

Trade-offs I guess. Regulate the sale of _some_ emergency medicines so that
those who need them now can afford them at the expense of, what exactly? It's
not like regulating the sale of _one_ medicine is going to break a
pharmaceutical company?

Why do I feel like I'm trying to defend sensible pricing here? Are people
really that allergic to the word _regulation_?

------
aaavl2821
The price will probably be lower, as the article suggests, but there are
currently epipen shortages so teva can charge more until the shortages are
resolved.

Typically the second generic product brings the largest price reduction [0].
However epipen is a unique scenario. I'm not sure how hard it is to develop a
generic epipen, but it is definitely not a straightforward small molecule
generic, so presumably there will be fewer generic versions than you see with
drugs like lipitor. So it is possible that the market resolves to an oligopoly
with 3-5 players that all make decent profits; there is precedent for this (i
think the pancreatic enzymes market is an example)

[0]
[https://www.fda.gov/aboutfda/centersoffices/officeofmedicalp...](https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm129385.htm)

~~~
btilly
A generic epipen is not only not hard to develop, but you can find youtube
videos explaining how to build one yourself.

See [https://spectrum.ieee.org/the-human-
os/biomedical/devices/ha...](https://spectrum.ieee.org/the-human-
os/biomedical/devices/hackers-offer-a-diy-alternative-to-the-600-epipen).

~~~
opencl
It's not even 'building' one, it is literally just buying a commercially
available FDA approved autoinjector and a vial of epinephrine to load into it.

It is really strange that the FDA is totally fine with diabetics buying vials
of insulin and loading their own autoinjectors, but doing the same thing with
epinephrine is apparently extremely dangerous and the FDA doesn't want you to
do it[1].

[1] [https://www.in-
pharmatechnologist.com/Article/2016/09/22/US-...](https://www.in-
pharmatechnologist.com/Article/2016/09/22/US-FDA-warns-against-30-alternative-
to-Mylan-s-EpiPen)

~~~
SlowRobotAhead
Insulin isn’t as dangerous for minor mess ups.

Epi is a drug that is a vascodialator in large muscles and a vascoconstrictor
in small muscles.

If you inject the right amount of insulin in the wrong place, not much
happens. If you inject the right amount of epi in the wrong place like a
finger, you could lose that finger.

You could argue a diabetic’s ability to administer during an event is just as
bad someone in anaphylaxis all day long... one is passed out and the other is
panicking because they are dying...

But epipen’s unique injector is primarily to get the right amount in the right
place. Two part problem it solves over the vial.

~~~
btilly
I bet more people have died because there was no pen present (too expensive)
than would have died from incorrect administration of a cheaper pen. So the
design of the epipen solves a problem, but are we making the right tradeoff in
insisting on using that solution at a high price point?

This is like the fact that TSA searches make another 9/11 less likely, however
people driving instead of flying to avoid the hassle is estimated to have
killed more people than 9/11 itself did. Risk is a funny thing, and isn't
always straightforward to figure out.

Making it personal, in theory my daughter should have 2 epipens close at all
times because if she gets stung on the neck, she could need one. Anywhere else
is OK, the concern is swelling from her allergy cutting off airflow. That
explains one, and the second is in case the first fails to work properly,
which sometimes happens.

In practice there is an epipen for her at school, and at her mother's house,
but not at my house. We shelled out once. But we're not shelling out over and
over again to prevent such an unlikely disaster. (Twice more so that there are
the recommended number of pens at school and both places she lives, then more
as we lose them since they are supposed to always be on us..soon we're talking
about real money!)

~~~
SlowRobotAhead
So... you can can get checked out on and get a script for the vile of epi.
Adjusts typically get .3mg and kids .15mg iirc. For the normal 1mg/mL stuff...
and that’s for anaphylaxis of course, not a heart attack.

That’s cheap and pretty easy to do. The problem is while maybe I’m a superstar
with a vile on someone else, I wouldn’t trust I could do it while my throat
was literally closing, in all scenarios. The pen makes sense a lot of time,
but the vile is good if you know you won’t be the target.

Something you wrote also, 2 pens. If you need one, there is a good chance
you’ll need two. Depends on how fast you can get to a hospital and the
circumstances with the victim.

So in that case, the vile makes even more sense for you to have at home.

------
Sam_Odio
> The pricing appears to undercut a notion promoted by FDA officials that
> approving more generics can help relieve the pocketbook pressure many
> Americans feel over the cost of their medicines.

I'm surprised the author is making the arugment that more competitiion doesn't
drive down prices - despite the large body of evidence to the contrary.

It's accepted belief that when competition fails to drive down pricing among
pharmaceuticals, it's usually due to regulatory decisions. There are several
studies that have been done on this exact topic, one even finds that price
regulation actually leads to higher prices by discouraging market forces [1].

1\.
[https://www.regjeringen.no/globalassets/upload/kilde/hod/hdk...](https://www.regjeringen.no/globalassets/upload/kilde/hod/hdk/2006/0016/ddd/pdfv/291420-vedlegg.pdf)

~~~
Symmetry
Normally competition means companies can make as many of a product as they
want in order to gain market share from each other. FDA regulated drugs often
operate on a production quota system where a given company is only allowed to
manufacture a pre-approved amount. If the FDA decreased the EpiPen quota by
the same amount that the generic was allowed to be produced in then you might
not expect to see any reduction in price. Of course they might have just left
EpiPen's quota the same, the article doesn't have that sort of information and
it might not be publicly available.

~~~
nordsieck
> FDA regulated drugs often operate on a production quota system where a given
> company is only allowed to manufacture a pre-approved amount.

My understanding is that this only applies to Schedule I and II drugs.

The Epipen, along with most other pharmaceutical drugs, do not fall under
those categories.

~~~
stallmanite
Are schedule I drugs allowed to be manufactured at all? I thought schedule I
meant the FDA has determined that no medical use exists.

------
creaghpatr
The former pharma exec working for HHS to negotiate lower drug prices
committed suicide about a month ago.

[https://www.cleveland.com/metro/index.ssf/2018/11/death_of_h...](https://www.cleveland.com/metro/index.ssf/2018/11/death_of_hhs_official_daniel_b.html)

~~~
inetknght
> _suicide_

> _multiple blunt force injuries_

Maybe I'm just a conspiracy theorist but I'm curious to learn more

~~~
lightbyte
>Police say Best was found "unresponsive" near the garage door exit of an
apartment building

A non-conspiracy possibility is he used the garage door to commit suicide, and
the bouncing door is what caused the blunt force injuries

~~~
ams6110
Unlikely. Garage doors have safety mechanisms that will reverse or at least
stop a closing door if there's an obstruction.

My guess was that he jumped from the roof, and was found by the garage door.
That would explain the blunt force trauma.

~~~
SlowRobotAhead
They also don't have anywhere near the amount of torque required to smash a
person.

------
misiti3780
I recently found out I have an allergy but do not know what it is. I tried to
buy an EpiPen in NYC and I was told

1\. 2 pens cost > $400 usd

2\. They have not had any in NYC for over 2 months because of shortages

~~~
dboreham
Hmm...odd. We previously would buy my son's EpiPens in Canada (when in Canada
for other reasons), but recently CVS has had an equivalent product that we've
bought. I forget the price but the fact I forget it tells me it was
reasonable.

...<digs pen out>...ok, it is made by "Impax" and labeled "epinephrine
injection, USP"

~~~
niftich
The product you got at CVS [1] is made by Impax and is an FDA 'Authorized
Generic' [2] for Adrenaclick, also made my Impax. It's effectively Adrenaclick
with the branding intentionally omitted, and the CVS out-of-pocket price is
109.99 USD for pack of two.

[1] [https://www.cvs.com/content/epipen-
alternative](https://www.cvs.com/content/epipen-alternative) [2]
[https://www.fda.gov/drugs/developmentapprovalprocess/howdrug...](https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm126389.htm)

------
russdill
This hopefully surprises no-one. Teva and Mylan are very similar companies
with very similar profit strategies:

[https://www.fool.com/investing/2017/10/11/mylan-deals-a-
blow...](https://www.fool.com/investing/2017/10/11/mylan-deals-a-blow-to-teva-
pharmaceutical.aspx)

~~~
russdill
This also comes as Teva, Mylan (and others) are facing a price fixing lawsuit:

[https://www.beckershospitalreview.com/pharmacy/20-generic-
dr...](https://www.beckershospitalreview.com/pharmacy/20-generic-drugmakers-
must-answer-price-fixing-lawsuit.html)

And also a criminal probe (not sure what the status of these are):

[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)

------
dpeck
What happened to the lower cost generic offering that CVS was touting all over
last year? Is it not pushing down prices across the board?
[https://arstechnica.com/science/2017/01/cvs-just-
announced-a...](https://arstechnica.com/science/2017/01/cvs-just-announced-a-
super-cheap-generic-alternative-to-epipen/)

~~~
gamblor956
They have been offering it for more than a year in stores...

[https://www.cvs.com/content/epipen-
alternative](https://www.cvs.com/content/epipen-alternative)

------
warent
Do you suppose it could be feasible to create a nonprofit organization which
produced low price EpiPens that made just enough to cover expenses?

~~~
nathancahill
Four Thieves Vinegar Collective:
[https://motherboard.vice.com/en_us/article/43pngb/how-to-
mak...](https://motherboard.vice.com/en_us/article/43pngb/how-to-make-your-
own-medicine-four-thieves-vinegar-collective)

Discussion on HN:
[https://news.ycombinator.com/item?id=17629436](https://news.ycombinator.com/item?id=17629436)

~~~
sigstoat
part of what you're paying for with your drugs is quality control to ensure
that you 1) made what you wanted to make 2) didn't contaminate it with
something you didn't want.

~~~
morpheuskafka
You should take a look at the documents I FOIAd from FDA (the parts they
didn't redact that is--apparently my appeal will take 3 years to be
processed). Median Medical Technologies, Inc. (a Pfizer company that produces
and owns patents for the EpiPen) violated numerous safety rules and breached
aseptic manufacturing multiple times, and did not appropriately investigate
failures.

Here's one of their violation letters, I was told that sanctions were still
being considered for the latest inspection.

[https://www.fda.gov/iceci/enforcementactions/warningletters/...](https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm574981.htm)

[https://drive.google.com/drive/folders/1BgduIfkAL4SaYVQu1yyJ...](https://drive.google.com/drive/folders/1BgduIfkAL4SaYVQu1yyJXp08q9kJJGa7?usp=sharing)

------
dev_dull
So, why not just import these pens from UK or Canadian producers who make them
at scale and for much cheaper? Or better yet, create a joint venture to
manufacture them cheaply in places like India?

~~~
Symmetry
That would be quite illegal, those UK and Canadian epiphendrine injectors
haven't been subject to FDA regulation. It would be a really good idea,
granted, but there are plenty of less radical ways to solve the problem. It
doesn't seem to have a positive effect on health outcomes (due to effects on
availability) but US drug regulations are pretty much the tightest in the
world and allowing foreign imports would be a relaxation of that.

~~~
amyjess
Unless the drug in question is a controlled substance, it's only illegal to
sell Rx-only medications, not to buy them. On the extremely rare chance
customs confiscates your shipment (which in practice only happens one week a
year, during Operation Pangea), all that will happen to you is that your
package will be empty.

I'm not linking them here (just because I don't want to get YC/HN in trouble),
but there are a number of highly-reputable online pharmacies in India and
Vanuatu that sell non-controlled medications and ship to the US. I haven't
checked whether or not they sell EpiPens, but I wouldn't be surprised. I'm
aware of them because they are very popular in the transgender community due
to high barriers to accessing medical care by legitimate means.

------
pravda
Why would the price be any lower?

If it costs $12.53 to manufacture an EpiPen equivalent, and the market price
of the EpiPen is $300, it would make no sense to sell it for any price other
then $300.

~~~
mtgx
Can you really say the "market price is X" when there's only been one company
making it?

Either way, I think there are some hidden forces here that keep these prices
so high. Like if the FDA would open the _market_ to competitors from Europe,
or even countries like India, I think that "market price" you say would
dramatically lower.

I think the U.S. pharmaceuticals market both lacks competition from generics,
as well as has some weird laws like "Medicare can't negotiate prices with
pharma companies," which only encourages pharma companies to raise their
prices as much as possible.

The law I mention is almost solely responsible for all the "drug X increased
price by 5,000%" headlines you've seen lately. Pharma companies have figured
out they can shamelessly rob taxpayers and nobody will do a thing about it, as
long as they donate to the right politicians (from both parties).

~~~
niftich
It's worth noting that the Teva device that's the subject of the article is
what the FDA considers an 'Authorized Generic'. From the press release [1]:

> _" An authorized generic is made under the brand name’s existing new drug
> application using the same formulation, process and manufacturing facilities
> that are used by the brand name manufacturer. The labeling or packaging is,
> however, changed to remove the brand name or other trade dress. In some
> cases, a company may choose to sell an authorized generic at a lower cost
> than the brand-name drug product."_

While this is different from what common language calls a 'generic drug' [2],
in some cases either kind of "generic" could, may, or must be substituted by
pharmacists, depending on various circumstances and the particular state's
regulatory regime [3].

This interacts with the epinephrine autoinjector market in two ways. First,
there is little upside for the manufacturer of the authorized generic to make
the list price significantly lower, as the list price is rarely paid by the
end-user out of pocket, and frequent mandatory substitution laws cause makers
of Authorized Generics to gain marketshare as long as they're slightly cheaper
than the brand

Second, Authorized Generics of combination devices are only subsitutable for a
corresponding brand, so different devices like Auvi-Q and Adrenaclick are
technically a different market entirely: the doctor's prescription will note
the exact sort of device. Therefore, while there are other epinephrine
autoinjectors, the marketshare among them is decided in doctor's offices and
insurance plans, rather than by direct consumer choice through the end-user's
own spending.

[1]
[https://www.fda.gov/newsevents/newsroom/pressannouncements/u...](https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm617173.htm)
[2]
[https://www.fda.gov/drugs/developmentapprovalprocess/howdrug...](https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm126389.htm)
[3] (2008) (for illustration only)
[https://www.uspharmacist.com/article/generic-substitution-
la...](https://www.uspharmacist.com/article/generic-substitution-laws)

~~~
paulie_a
You can tell your doctor to prescribe a cheaper alternative. If the doctor has
no reason to not do so, time to get a new doctor.

------
tracker1
Limit patent licensing for medical patents for prescribed medications to $15
each, or $1/day which ever is less. Limit patent licensing to $50 for
prescribed devices.

Reduce extension patents on medications or medical devices to no more than 5
years (same for software).

Make it take an act of congress to change/raise those amounts in the future
with a super majority.

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

It all goes back to the original problem. Even when the FDA gets their act
together and let a single competitor compete it still has a ripple effect.

------
scottshea
My daughter has used the Auvi-Q as an alternative. In addition to the active
injectors they provided a test one that helped her when the time came:
[https://www.auvi-q.com](https://www.auvi-q.com)

I have not heard of any issues with Auvi-Q since it was reintroduced

~~~
anonymous54249
I asked my son's allergist about those, and was surprised to learn that they
cost an order of magnitude more than epi pens. He wouldn't prescribe them
because he refuses to support that kind of pricing.

BTW epi pens also come with a tester.

(We have insurance so we pay a small copay for epi pens and auvi-q would be
free.)

~~~
scottshea
Interesting. Our allergist said almost the exact opposite in that they refused
to prescribe EpiPen because it was so much higher than Auvi-Q.

And I wonder when EpiPen started issuing testers. We had them for years (me
first, then my daughter) and never got one.

~~~
lostcolony
Cost to patient, or cost to insurance. Auvi-Q is much greater cost to
insurance, less to patient. The former is still a major concern given how that
leads to increased premiums and general medical pricing inflation, even if it
briefly benefits the individual.

------
Shivetya
Well the part that matters the most is that the FDA has increased the number
of generics approved and as long as that statistic keeps improving without
putting anyone at risk it is a good thing.

------
pessimizer
There was not a chance that the price of EpiPen was going to go down. Manchin
exists, and Democrats were going to have to drive change. Once Shkreli was
jailed for charges completely unrelated to drug pricing, all of the gas was
taken out of the media panic. Bresch was an excellent choice for a CEO, even
without an MBA.

In my experience 99.9% of people I talk to think that Shkreli went to jail for
drug overpricing, take some patriotic joy from that fact, and think that one
of the results of his jailing is that EpiPens are cheaper. It's like how
everybody thought that Saddam did 9/11.

------
tmaly
I think the article should state clearly if the price is with or without
health insurance.

I bought a generic epipen this year for my daughter and the co-pay was $4.

~~~
munk-a
I agree that this article is misleading but the cost to consume is super hard
to get to in most cases. Most pharma companies don't know what price the end
consumer ends up paying due to all the complications of the convoluted health
insurance system, to find the cost and prior authorizations of a drug you may
need to consult a dozen separate documents, and if you've got spousal
insurance all that complication doubles or more.

------
pkaye
Why is there such an increasing demand for EpiPen type products? Are more
people becoming allergic to stuff?

~~~
tropdrop
Yes. Food allergy in children has increased 50% from 1999 to 2011 [1].

1\.
[https://www.foodallergy.org/sites/default/files/2018-04/FARE...](https://www.foodallergy.org/sites/default/files/2018-04/FARE-
Food-Allergy-Facts-Statistics.pdf)

~~~
londons_explore
When the cause of food allergies is discovered, a lot of people are going to
laugh at how quite so many people could be affected before we found out which
chemical causes them.

~~~
tracker1
With the number of changes in farming and GMO products, production soil, other
effects of industrial farming, etc, etc, it's not surprising. More diversity
in marriage and resulting younger generations can also change/increase allergy
profiles as well, since you may now have reactions to things that effect
either parent or to a greater extent.

It's complicated, to say the least. Also, you can go most of your life with
smaller reactions to something before it starts to get bad. (Discovered legume
allergy at 40yo)

------
timwaagh
i think it could be much worse. the fact that there is a competitor means the
former monopolist cannot raise prices of their 'lets avoid a scandal' $300
version back up to 600, which is closer to the profit maximising price for the
product in a monopoly market.

------
shmerl
Why should adrenaline shot be so crazy expensive? Nothing about it sounds
complicated.

~~~
Unibod
Possibly my first post, so sorry if I have make faux pas. In the UK the
national health service [NHS] engages nationally to negotiate price. They have
the concept of the value of a medicine compared to the improved quality of
life it brings. As a result generic medicines are priced against their value.

This means that an epipen is priced at £45 or about $60. Google Lloyds
pharmacy epipen - UK only search.

I rather like this approach to healthcare, I am not sure about transnational
ability to buy this - but to those that need it I hope you can make it work.

My observation is that the UK approach to healthcare has some advantages in
its approach, it is not without faults but value for money [affordability] is
embedded in delivery.

