EpiPens, useful medical devices which reverse potentially fatal allergic reactions, have recently quadrupled in price, putting pressure on allergy sufferers and those who care for them. Vox writes that this “tells us a lot about what’s wrong with American health care” – namely that we don’t regulate it enough:

The story of Mylan’s giant EpiPen price increase is, more fundamentally, a story about America’s unique drug pricing policies. We are the only developed nation that lets drugmakers set their own prices, maximizing profits the same way sellers of chairs, mugs, shoes, or any other manufactured goods would.

Let me ask Vox a question: when was the last time that America’s chair industry hiked the price of chairs 400% and suddenly nobody in the country could afford to sit down? When was the last time that the mug industry decided to charge $300 per cup, and everyone had to drink coffee straight from the pot or face bankruptcy? When was the last time greedy shoe executives forced most Americans to go barefoot? And why do you think that is?

The problem with the pharmaceutical industry isn’t that they’re unregulated just like chairs and mugs. The problem with the pharmaceutical industry is that they’re part of a highly-regulated cronyist system that works completely differently from chairs and mugs.

If a chair company decided to charge $300 for their chairs, somebody else would set up a woodshop, sell their chairs for $250, and make a killing – and so on until chairs cost normal-chair-prices again. When Mylan decided to sell EpiPens for $300, in any normal system somebody would have made their own EpiPens and sold them for less. It wouldn’t have been hard. Its active ingredient, epinephrine, is off-patent, was being synthesized as early as 1906, and costs about ten cents per EpiPen-load.

Why don’t they? They keep trying, and the FDA keeps refusing to approve them for human use. For example, in 2009, a group called Teva Pharmaceuticals announced a plan to sell their own EpiPens in the US. The makers of the original EpiPen sued them, saying that they had patented the idea epinephrine-injecting devices. Teva successfully fended off the challenge and brought its product to the FDA, which rejected it because of “certain major deficiencies”. As far as I know, nobody has ever publicly said what the problem was – we can only hope they at least told Teva.

In 2010, another group, Sandoz, asked for permission to sell a generic EpiPen. Once again, the original manufacturers sued for patent infringement. According to Wikipedia, “as of July 2016 this litigation was ongoing”.

In 2011, Sanoji asked for permission to sell a generic EpiPen called e-cue. This got held up for a while because the FDA didn’t like the name (really!), but eventually was approved under the name Auvi-Q, (which if I were a giant government agency that rejected things for having dumb names, would be going straight into the wastebasket). But after unconfirmed reports of incorrect dosage delivery, they recalled all their products off the market.

This year, a company called Adamis decided that in order to get around the patent on devices that inject epinephrine, they would just sell pre-filled epinephrine syringes and let patients inject themselves. The FDA rejected it, noting that the company involved had done several studies but demanding that they do some more.

Also, throughout all of this a bunch of companies are merging and getting bought out by other companies and making secret deals with each other to retract their products and it’s all really complicated.

None of this is because EpiPens are just too hard to make correctly. Europe has eight competing versions. But aside from the EpiPen itself, only one competitor has ever made it past the FDA and onto the pharmacy shelf – a system called Adrenaclick.

And of course there’s a catch. With ordinary medications, pharmacists are allowed to interpret prescriptions for a brand name as prescriptions for the generic unless doctors ask them not to. For example, if I write a prescription for “Prozac”, a pharmacist knows that I mean anything containing fluoxetine, the chemical ingredient sold under the Prozac brand. They don’t have to buy it directly from Prozac trademark-holder Eli Lilly. It’s like if someone asks for a Kleenex and you give them a regular tissue, or if you suggest putting something in a Tupperware but actually use a plastic container made by someone other than the Tupperware Corporation.

EpiPens are protected from this substitution. If a doctor writes a prescription for “EpiPen”, the pharmacist must give an EpiPen-brand EpiPen, not an Adrenaclick-brand EpiPen. This is apparently so that children who have learned how to use an EpiPen don’t have to relearn how to use an entirely different device (hint: jam the pointy end into your body).

If you know anything at all about doctors, you know that they have way too much institutional inertia to change from writing one word on a prescription pad to writing a totally different word on a prescription pad, especially if the second word is almost twice as long, and especially especially if it’s just to do something silly like save a patient money. I have an attending who, whenever we are dealing with anything other than a life-or-death matter, just dismisses it with “Nobody ever died from X”, and I can totally hear him saying “Nobody ever died from paying extra for an adrenaline injector”. So Adrenaclick continues to languish in obscurity.

So why is the government having so much trouble permitting a usable form of a common medication?

There are a lot of different factors, but let me focus on the most annoying one. EpiPen manufacturer Mylan Inc spends about a million dollars on lobbying per year. OpenSecrets.org tells us what bills got all that money. They seem to have given the most to defeat S.214, the “Preserve Access to Affordable Generics Act”. The bill would ban pharmaceutical companies from bribing generic companies not to create generic drugs.

Did they win? Yup. In fact, various versions of this bill have apparently failed so many times that FDA Law Blog notes that “insanity is doing the same thing over and over again and expecting different result”.

So let me try to make this easier to understand.

Imagine that the government creates the Furniture and Desk Association, an agency which declares that only IKEA is allowed to sell chairs. IKEA responds by charging $300 per chair. Other companies try to sell stools or sofas, but get bogged down for years in litigation over whether these technically count as “chairs”. When a few of them win their court cases, the FDA shoots them down anyway for vague reasons it refuses to share, or because they haven’t done studies showing that their chairs will not break, or because the studies that showed their chairs will not break didn’t include a high enough number of morbidly obese people so we can’t be sure they won’t break. Finally, Target spends tens of millions of dollars on lawyers and gets the okay to compete with IKEA, but people can only get Target chairs if they have a note signed by a professional interior designer saying that their room needs a “comfort-producing seating implement” and which absolutely definitely does not mention “chairs” anywhere, because otherwise a child who was used to sitting on IKEA chairs might sit down on a Target chair the wrong way, get confused, fall off, and break her head.

(You’re going to say this is an unfair comparison because drugs are potentially dangerous and chairs aren’t – but 50 people die each year from falling off chairs in Britain alone and as far as I know nobody has ever died from an EpiPen malfunction.)

Imagine that this whole system is going on at the same time that IKEA spends millions of dollars lobbying senators about chair-related issues, and that these same senators vote down a bill preventing IKEA from paying off other companies to stay out of the chair industry. Also, suppose that a bunch of people are dying each year of exhaustion from having to stand up all the time because chairs are too expensive unless you’ve got really good furniture insurance, which is totally a thing and which everybody is legally required to have.

And now imagine that a news site responds with an article saying the government doesn’t regulate chairs enough.

They make very little on it, and on stuff like EpiPen, probably lose money.

This is pure greed and nothing more.

To think it's only greed is naive, possibly stupid.

Don't know if it's true, but I heard yesterday that you can buy the drug at a local drugstore, buy a syringe, and make one yourself on the cheap

simplistic and sophomoric. There is so much more than that at play with drug prices. If you think prices are too high, in general, it's because of the FDA or the DOJ. Both drive the price. Blame a politician, a bureaucrat or a lawyer, not the company that makes and sells the product. They make very little on it, and on stuff like EpiPen, probably lose money.

Lolol. That's the silliest thing I've heard in awhile. Simplistic and sophomoric not to mention ignorant and uninformed describes MY post.

Drugs vs. Chairs

The problem with the pharmaceutical industry is that they’re part of a highly-regulated cronyist system

simplistic and sophomoric. There is so much more than that at play with drug prices. If you think prices are too high, in general, it's because of the FDA or the DOJ. Both drive the price. Blame a politician, a bureaucrat or a lawyer, not the company that makes and sells the product. They make very little on it, and on stuff like EpiPen, probably lose money.

Big fish, You're over your head on this one, son. How many epi shots have you given in your life for allergic reactions? How many times have you pushed epi during a cardiac event? The FDA is a joke and shares a tremendous amount of blame for the prescription drug problems this country faces but this situation IS NOT the fault of the FDA.

Instead of changing my post, which I expected some dipshlt to do, you should educate yourself. It would help you to look less foolish, ignorant and immature.

Their price for epipen is simply unconscionable.

They used to cost $15. (A long time ago). And there's less than a dollar's worth of epinephrine in them. Plus the price of an injector.

It's the safety and convenience you're buying.

It was safe and convenient At $50 too.

Yep.

The greed involved is holding allergic people financially hostage.

It's the sort of move that makes people make bad decisions.

wonder if a convention of states will ever happen. Fed.Gov is out of control.

Then answer my damn question: Why doesn't someone just start making and selling EpiPens and selling them for $20 a pop?

It's a really easy answer.

The manufacturer or the patent owner sets the price not the FDA. Capiche?

simplistic and sophomoric. There is so much more than that at play with drug prices. If you think prices are too high, in general, it's because of the FDA or the DOJ. Both drive the price. Blame a politician, a bureaucrat or a lawyer, not the company that makes and sells the product. They make very little on it, and on stuff like EpiPen, probably lose money.

Lolol. That's the silliest thing I've heard in awhile. Simplistic and sophomoric not to mention ignorant and uninformed describes the quoted post.

The cost of the drug gets mentioned in every complaint about Epi-Pen, but it's really meaningless since it's not just the drug one pays for.

It's the safety and convenience you're buying.

The R&D on them, as well as the FDA studies on them, were done decades ago.

They charge as much as they can get away with. I think they found that point now.

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.

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.

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.

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.

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.

Did you read the part about the CEO of the epi-pen co. being the daughter of the politician Joe Manchin, or the fact the FDA interfered, and the competitors being denied by approval the FDA?

Not to mention the lobbyist.

Can you say pay to play?

We are becoming a banana republic.

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

Historically the price of epi precluded other companies from replicating the product.

The FDA is a major problem, but in this case they don't shoulder the blame for the 500%+ price increases. Politics, cronyism and greed are the culprits in this case.

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.

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.

Pete,

Do you have advisability if that price is subsidized and if so buy how much?

I guess a better way to look at it would be 'not making the profit margin they targeted'. Lots of factors can impact that, including, but not limited to State contracts, federal contracts, litigation, gearing up for a new version of the pen, HR costs, material costs, new EPA or FDA regulations in the manufacturing process................the list is endless.

this is where I usually insert GFY. If only I could be like you. laughing