Home Forums Hunting & Shooting Hunter's Campfire Epi-pen 'splaining, Reverse VOX Style

That's right IB. Epinephrine is not new, isn't subject to recovering R&D costs nor is it an uncommon or highly specialized drug. In fact the opposite is true

Pure selfish, uncaring greed is the only motivation. Mylan does present a compelling argument FOR government mandated price controls however with this bullchit.

OK I will try to not be a dick (I'm good at that).

It takes $2,000,000 to $3,000,000 to get the FDA to go through the approval process... and up to 10 years in a lot of cases. It also takes so much paperwork to give to the FDA that it has to be delivered in a semi. That paperwork has tied up in it millions in research and lawyer and other associated costs.

That is the main barrier to which I refer, and the FDA is part of the federal government.

Another barrier is lawsuits brought by the patent holder. Of course they don't want any other entrants to the market- they want the monopoly/corner on the market so they can continue to make big bucks. How do they make more money? Raise prices since there's no other competitors. When your 20 years runs out on the patent, other generics can enter the market and you no longer have the market cornered.

As I understand it (and could be wrong on this point), others (henceforth 'little guy') have tried to enter the market but the patent holder sued the little guys successfully and somehow demonstrated to a judge that their patent was somehow infringed. This is the name brand meds vs. generic meds stuff you hear about all the time- generic is cheaper because the patent ran out and little guys entered the market.

Now in this case we have the courts and the FDA (henceforth: tha guvment) preventing the little guy from bringing his generic to market. This leaves the patent holder with their corner on the market. So why did the price go up?

1) Patent holder still has a monopoly on the market
2) Patent holder's CEO has responsibility to the shareholders and the board of directors to make stock go up and to make the company money, so they raise prices on the captive market (I'm not saying it is right, but a CEO that doesn't maximize profits is quickly replaced). This is why the price is now what I would call an unconscionable $630.

Is it right or ethical? I'd lean to 'no' at $630 a pop. But the bottom line is tha guvment (via primarily the FDA's high $$ barrier and the court's upholding patent infringement) is fugcking this all up.

I'm sure it's slightly more complicated, but to understand the problem you have to first understand why basic supply/demand isn't working like it should. Once you understand one outfit controls the entire supply, things become a little more clear. Once you understand how that one outfit remains the sole supplier, you see how the whole supply/demand thing works and prices are raised.

I'll quote Sam again:


Only thing I disagree with is his last sentence. They're making plenty off this particular EpiPen product- it's dirt cheap.

The government gives you a 20 year patent when you 'invent' a new medicine. This allows the inventing outfit to hold a 20 year monopoly to recoup their operating costs (lawyers, researchers, 'ransom' $2-3M to the FDA, other operating costs, etc). After that other manufacturers can move in and undercut the market (unless they get their asses sued off and lose).

Do I agree with the $630 price? Of course not. But the patent holder has managed to keep their monopoly, right or wrong. And they can charge whatever they want. If I were the CEO of that company, I'd be charging a first-born for the EpiPen too, lest I get my ass fired. It's only because they can charge it that they do. They can only charge that price because the government has kept competitors out of the market. If someone brought another equivalent product to market for $20, no one would ever buy a $630 EpiPen.

not all of us can be a brain trust like you. I only spent years and years in the business. I think I have a dang good idea of how it works, and who is responsible for pricing.

EPI-PENs did cost more than the price I gave. I found an old bill. Like $40 for the bill I found. I corrected the original post.

No, it's a new drug because it is in a new format. The FDA isn't going to rubber stamp it without researching it, regardless of whether it's the same active ingredient+delivery method or not. That's not how the FDA works. If you don't like it, talk to your congress critters.

They can only get away with charging that much, because tha guvment has the infrastructure in place (FDA and courts) keeping a high barrier to entry in the market.

You guys, please stop letting your emotions get in the way of seeing clearly here just because someone is charging an exorbitant price because they can. That's called capitalism. The problem is tha guvment keeping competitors out of the market for one reason or another.

I worked in the medical industry long enough to see how tha guvment was screwing people over... and that was before Obamacare. Dying of cancer and there's a miracle drug that may cure you but it isn't FDA approved yet? TOO STINKING BAD!!! They're not going to rush approve it, even "if it can save just one life."

ETA Sam, I'd not mind hearing why you think this company might be losing money selling EpiPens @ $630 a pop.

Just now saw on news one can buy "personal amount" of brand name Epi pens in Canada, no prescription, for just over $100 and bring them back across border no problem. Helps to live near the border I imagine to keep costs down for consumers.

Probably already a thriving black market.

Why does it need replacing 2x annually? Drug deteriorates?

Yeah, that's true. And a company can count on an expense of 100-300 million to jump through the FDA hoops for approval.

At least, according to the companies. And I'm a bit curious about how much review and confirmation of the data presented by the company actually is done by the FDA.

So they can sell $10 worth of product and packaging (if that) in Canada for a $100 profit , but not in the US? Even with R&D. And pay CEO 19m a year.

If they weren't turning a profit in Canada, would they be there ?

Yeah I know about loss leader stuff and this ain't it.

I was talking about MYLAN itself. They don't have ANY of those costs to take into consideration.

More Brand Products

PRODUCT LOWEST UNIT PRICE
Epipen 0.3mg
Product of United Kingdom — Manufactured by: MEDA PHARMACEUTICALS $112.71 USD/pen
Epipen 0.3mg
Product of Canada — Manufactured by: Pfizer $158.52 USD/pen
Epipen 0.3mg
Marketed as Jext Pre-Filled Pen 300mcg in United Kingdom — Manufactured by: ALK-Abello This product is currently on back order.
Epipen 0.3mg
Product of New Zealand — Manufactured by: Mylan Pharmaceutical $131.11 USD/pen
Epipen 0.3mg
Marketed as Epipen Twin pack in United Kingdom — Manufactured by: MEDA PHARMACEUTICALS $113.70 USD/pen
No generic alternatives are available for this drug.


Above from a Canada Drug website.

The $2-3M to which I referred was just to get the process started and to the point where you basically drop off the drug at the FDA's doorstep. I did not mention the additional monies needed to get everything to the point where the FDA grants approval.

Just because they 'can' does not mean they 'should'.

Greedy bastards price gouging the piss out of folks unfortunate enough to have life threatening allergic reactions...or have children unfortunate enough to have life threatening allergic reactions.

If you have such a dang good idea of how it works then why are you being a dumb ass? I know you're a grumpy, down in the mouth old restauranteur with nothing positive to ever say about anything so tell us your experience with epinephrine and the restaurant business. One doesn't need to be a "brain trust" to know when you're full of shlt. Most of the time people pass over your negative Bullshlt but sometimes it's fun to call you on it. You are wrong but too old and pissed off at the world to admit it. Go buy a clue and STFU unless you think you can substantiate your Bullshlt.

BTW Sammy, epi is short for epinephrine not epicurean. I'm sure you make a mean tuna fish sandwich but I'll pass on taking pharmaceutical and medical advice from a guy that spent his life slinging food for a living.

PS...I also won't seek your advice on woman, marriage or happiness. You'd be smart to stick to things you know. The cooking forum is your huckleberry.

Epipen is a symptom of the problem of greed in our healthcare system. Surgeries that cost 300,000 and medications that double over night and health care premiums that are unaffordable and double every year. Not to mention the medicsl procedures found ineffectual and unnecessary every year. Our healthcare system is terrible

I did not read every post on this thread, but here goes. Any time the Government mandates anything, look for a big price increase. I read in one post where Schools were mandated to keep so much on hand, and it has a shelf life, so they have to buy new ones, even when they were not used, so bend over, everybody. miles

Miles, Very true that's why I'm surprised by the big democrat supporters like Sammy. The Mylan CEO is the daughter of demorat Manchin of WVa. She's raised the price of the product, bonuses herself and used millions to lobby for schools to keep her product on every campus across the country. Big government looking to line their pockets at the cost of Anerican lives. It's unacceptable to anyone but a democrat, of which this forum has a lot, somem wear interesting disguises.

That's only the beginning. She is also a donor to the Clinton Foundation. And Obama had the Dept of Education mandate school districts to purchase Epi pens every year, even thought students cannot use them legally as they have to have a prescription and provide their own. When the government starts buying things from producers the cost shoot up due to paper work and other stipulations that have to be accommodated per contract.

They bought out the only other producer of Epi pens and created a monopoly that has gone unchallenged until now.

There are 8 competing verions in the EU. Only one has made it past the FDA. Therein lies the crux...