Prescription Drugs

Want to Reduce the Price of EpiPens? Approve Some Competition!

Capitalism isn't to blame. It's the exact opposite.

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Epipens
Anda Chu/TNS/Newscom

Angry lawmakers and Democratic presidential candidate Hillary Clinton are going to want us to see them as heroes for their efforts to shame pharmaceutical company Mylan into lowering the cost of an allergy treatment for some people.

EpiPens, used to provide injections of epinephrine in cases of severe, potentially life-threatening allergy attacks, have been creeping up in price from $100 to $600 per dose since 2009. This has become a political issue right now (at the height of an election cycle—go figure) partly because of attention by Sen. Amy Klobuchar (D-Minn.), whose daughter uses them. Clinton has waded into the debate and called the price hikes "outrageous, and just the latest example of a company taking advantage of its consumers."

It would be more accurate to say that the company is taking advantage of the fact that the federal government's own regulatory scheme has given them a medical monopoly. Clinton wants to cast herself and the government as the cure for this problem. It's actually the cause in any number of ways.

The Wall Street Journal detailed extensively as Clinton threw herself into the conflict that the Food and Drug Administration (FDA) has made it very difficult for competitors to enter the marketplace and push prices downward. Epinephrine is cheap and EpiPens have been around for decades. Their prices should be trending downward not upward. But the FDA's complicated (and ambiguous) process of approving other drug delivery systems has kept competitors off the market. And to be clear, there are other companies trying to participate and demonstrate they can provide safe alternatives:

But no company has been able to do so to the FDA's satisfaction. Last year Sanofi withdrew an EpiPen rival called Auvi-Q that was introduced in 2013, after merely 26 cases in which the device malfunctioned and delivered an inaccurate dose. Though the recall was voluntary and the FDA process is not transparent, such extraordinary actions are never done without agency involvement. This suggests a regulatory motive other than patient safety.

Then in February the FDA rejected Teva's generic EpiPen application. In June the FDA required a San Diego-based company called Adamis to expand patient trials and reliability studies for still another auto-injector rival.

Mylan's CEO, Heather Bresch, is the daughter of Democratic West Virginia Sen. Joe Manchin, by the way. Bresch is pointing the finger (accurately) toward the many different folks who have their hands in the till when it comes to drug sales. Part of the company's solution will be to allow people to order EpiPens directly from Mylan because "more than half the amount paid by the health care system for EpiPens goes to pharmacy benefit managers, insurers, wholesalers and pharmacy retailers, not to the company itself."

Yet, even as it's clear that both a lack of competition and the contributions of heavy regulation and bureaucracy play big roles in driving up drug prices, some people still want to lay the blame on capitalism.

It shouldn't come as a surprise if the ultimate outcome of the fight is some mild reduction of price so that lawmakers (and Clinton) can claim that they've fought the drug companies and won. Few will consider that approving those other delivery systems the Wall Street Journal mentioned might actually drive the costs to consumers down even further. Nobody's going to win votes that way.

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  1. Are libertarians still blaming Shkrelli’s price boosting on the patent system?

    1. Fuck that guy. The fact that less of the red tape and cronyism that the article discusses might make it so other companies could challenge him in a competitive market has little to do with how much that guy sucks.

      1. The fact that Daraprim’s medical patent expired many decades ago is lost on most people. Any company that wants to compete with Turing’s “monopoly” on treating toxoplasmosis encephalitis is free to do so, but these companies have never shown interest in the mere 2,000 patients a year Daraprim treats. Rare diseases don’t get a lot of attention from pharmaceutical companies. It seems silly, then, to vilify one of the few men who is willing to risk money investing in sick people that no one else is trying to help.

        1. Hmm. I’ll give that some reflection — best defense I’ve ever seen for the main; forgive me for letting the assault of ‘boo greedy capitalist monster!’ getting burrowed so deep in my subconscious, but that’s the overwhelming take on the dude that is then subsequently shoved down my throat.

        2. How much is he really risking when the drug already exists? It’s not as if he’s investing money in developing a drug that only 2000 people use.

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    3. It was never patents ? it was the drug trials that was the issue.

      1. Far more interesting? looks like drug companies like Retrophin (formerly employer of Shkreli) have been using the FDC’s Risk Evaluation and Mitigation Strategy to deny competitors access to information on their drugs to keep them from being able to even start drug trials.

        1. What is stopping another company from selling an identical epipen product under a different name? At worst, the maker might hold some patents on the delivery method that are at most 20 years old. So why not sell a product as it was sold 20 years ago? Epipens worked fine back then. My guess is that the FDA considers these old delivery methods outdated and does not allow them. That’s cronyist bullshit, if that’s the case.

    4. Are libertarians still blaming Shkrelli’s price boosting on the patent system?

      Lefties always seem to waste time on guys like this in “proving” capitalism as a flawed system, as if Venezuela and North Korea are somehow devoid of elitest douchebags. Pointing your finger at shitty people does nothing except show that once again, shitty people exist anywhere and everywhere.

    5. The FDA is evil and is mostly at fault for Shkreli’s pricing schemes by keeping competition from entering the marketplace. But he is still a douchebag no matter what he sells his drugs for.

      1. The problem is that the regulatory agencies have become too friendly with the industries they regulate. Big Pharma employs an army of lobbyists to protect their industry.

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  2. Don’t get me started on how impossible the FDA makes it to file to market a generic drug, even after the patent on the original has run out.

    1. THINK OF THE CHILDREN, YOU MONSTER!

  3. wrt that Vox article by Sarah Kliff, I could only get this far:

    The American government is exceptional in that it has no power to regulate drug prices.

    Done.

    1. If only we were a little more like Venezuela we wouldn’t have these problems. Duh.

      1. Yeah, we’d all starve before we had a chance to be stung by a bee and go into anaphylactic shock.

      2. And Bernie Sanders would support limiting the number of competitors, too!
        Hell, we don’t need so many brands of shampoo on grocery shelves… why should there be more than one epipen vendor?!

        /sarc.
        Bernie is an asshole, particularly when it comes to economics [not sarc.]

    2. They are the worst of the worst over there

  4. Libertarians think the answer to many questions is less government and more competition.

    The progressives think the answer is more government. Kliff wants us to be more like (wait for it) Canada and Europe.

    Of course, I think we’re correct, but that doesn’t change the fact we’ll never get progressives to see things our way.

    1. Kliff wants us to be more like (wait for it) Canada and Europe.

      I don’t know about Canada, but as far as Europe is concerned, that means he’d like us to be poorer, more likely to be unemployed, and completely at the mercy of big corporations and churches.

  5. Democrats get it wrong, news at eleven never.

  6. the latest example of a company taking advantage of its consumers

    Still waiting for leftists to give me an example outside of whatever crony industry is making rotations on the 6 o’clock news. You know… a business actually subject to market forces.

    Slightly OT: Every morning, I hear radio spots for Morgan & Morgan and their claims to “fight the establishment.” One of the ads specifically mentioned insurance companies, pharmaceutical companies, and the oil and gas industry. First time I heard it, despite not being fully awake, my first thought was “Aren’t those all beneficiaries of government intervention? Nah, couldn’t be a coincidence.” Of course, they spin it as “the evils of capitalism.”

    1. Story of humanity.

      People always, ALWAYS blamed or were suspicious of business.

  7. Maybe somebody could market epinephrine in an electronic vaporizing device – I’ve heard those things are completely unregulated and any schoolchild can easily get their hands on one in mere seconds.

    1. wouldn’t a epinephrine GUN be even easier. According to Obama they are easier to get than books are.

      1. Oh man, I spit out my coffee…you owe me a new keyboard.

      2. +1,000 High velocity epinephrine therapy!

    2. Well nebulized epinephrine is already a thing medically. Not sure how well it would work for anaphylaxis though, which is what the EpiPen treats. Honestly the EpiPen is way overprescribed, in my opinion. I’ve seen people with no history other than localized swelling from ant bites or bee stings carrying the damn things around.

      The dosing of nebulized epinephrine would probably need to be increased in order to get a significant systemic response and its effects on the respiratory tree might be a little unpleasant. I’ve accidentally gotten some epi on my finger and it felt quite weird for hours.

      Or were you just being sarcastic? ::Slaps sarcasm meter, checks batteries::

      1. I know people with serious risk of death who don’t bother.

        I thought it was interested seeing Mylan PSAs on the TV about the importance of taking your allergies seriously!

      2. If I get stung around the neck by a wasp, I probably won’t make it, unless someone happens to be handy who can open up an airway.

        I don’t carry an epipen, even though I’m around wasps all the damned time. If I carried defenses for everything in nature that COULD kill me, I’d have to ruck everywhere.

        1. You mean you don’t [ruck everywhere]?

      3. Honestly the EpiPen is way overprescribed, in my opinion. I’ve seen people with no history other than localized swelling from ant bites or bee stings carrying the damn things around.

        You don’t watch enough Hollywood movies, apparently. From those, you would have learned that pretty much half of all medical emergencies are “anaphylactic shock”, often precipitated by anything from a blow to the head or a gunshot wound to alien parasites and demonic possession.

        1. You’d also be amazed at how many people, upon visiting their doctor for a bee sting, are also given a prescription for antibiotics.

      4. the problem with nebulizing epinephrine is that if one is having an allergic reaction,the first thing is your airways get restricted. So you can’t breathe in the drug to be absorbed.
        that’s why it has to be injected.

    3. Would not work well for a number of reasons. Not the least of which is that one of the life-threatening symptoms of anaphylaxis is a closing off of the airway. IIRC it has been tested using epinephrin metered dose inhalers with poor general response.

      The other problem with vapers is the heat – epinephrine is not a super stable molecule and rapidly oxidized from heat or light.

    4. It is actually absorb-able through direct injection. It is used through administration (via an endotracheal tube) into the lungs. It can be used during cardiac arrest, along with cardiac compression, according to ACLS protocol. It may still be fraught with delivery problems.

  8. Capitalism killed my dog!

  9. This is another example of where libertarians fail despite having the winning argument.

    There is no question that lack of competition and government regulation are to blame for this particular drug to end up being the only option on the market, thus its cost becoming astronomical. Yet no one (except for free marketers) sees how this is so despite all the voices shouting at them to look at the evidence.

    It’s just too easy for everyone to blame the rich greedy fat cat Male Republican Female Democrat .

    1. It’s to be expected that politicians will offer up sacrificial lambs. Unfortunately it is to be expected that mass media will never question the necessity of sacred cows.

    2. Well, obviously the “greed” story is much easier to sell.

      Note that “greed” is a subjective reference and drive emotions.

      Free-market explanations are logic based. By the time you finish your 5 sentence free-market explanation, a politician can shout “greed” 50 times and amp up voters’ emotions.

  10. Few will consider that approving those other delivery systems the Wall Street Journal mentioned might actually drive the costs to consumers down even further. Nobody’s going to win votes that way.

    But, allowing other delivery systems wouldn’t allow the daughter of a connected Senator (wasn’t he one of the ones who backed Obamacare, by the way?) to run a company. So, ultimately, it’s for the children.

  11. We did it with a hypodermic and a vial of adrenaline and an onion tied to our belts.

    1. Which was the style at the time.

    2. Hypodermic needles are bad! War on drugs and all that!

  12. KDW over at National Review Online pretty much nails it (excert):

    Mrs. Clinton is a bum and a crook who used the State Department as a funnel to guide the money of favor-seeking business interests at home and abroad into the Clinton Foundation, a sham charity that exists to pay six-figure salaries to Clintons (Chelsea is full-time executive there) and their courtiers.

    These people are parasites. They make: nothing. They create: nothing. They produce: nothing. But they feel perfectly justified ? they positively glow with moral frisson ? standing between the people who create and build and the people who benefit from those creations. And they don’t just stand there: They stand there with their hands out. I don’t know how much Heather Bresch has in the bank, but without checking, I’ll bet you five dollars it is a good deal less than the Clintons have piled up in “public service.”

    1. Color me sceptical that Breach’s position as CEO is not because it gives the company an in with the political class. She s not a producer but a junior member of the Aristocracy of Pull.

      1. Completely agreed. Hell, her career path into the CEO suite was through the Government Relations department.

    2. Of course they feel perfectly justified?they make it possible, for without their cooperation, it would be impossible.

  13. High prices in one of the most highly regulated industries on the planet? Geez, who cudda predicted it? Must need more regulation to block out any new competitors control greedy corporations. Yup.

  14. “creeping up in price from $100 to $600 per dose since 2009”. Have Reason subscriptions crept up 500% since 2009? Just askin’

    And, yes, some competition could help.

  15. Thank goodness for the FDA. It weren’t for them Vioxx and Fen-phen would have actually made it to market and many people would have suffered.

  16. I heard a long report on this on the NBC news last night. Never did they identify the senator father as being a Democrat. You can believe if this was, say, one of Rand Paul’s or Jeff Flake’s kids, it would have been mentioned over and over again.

  17. I work in the aerospace industry, in the jet engine certification end of things. Everything that is needed for certification is agreed upon with the government before starting. Yes, there is a huge difference between turbofans and drugs, but in the case of the EpiPen, it’s only a delivery system of a long-used drug, and the patents have expired! The FDA should look into the FAA methodology, which will certainly streamline the process.

    1. IIRC,the government owns the design on the EpiPen. it was made for military use originally,for battlefield conditions,where one might only have one hand to administer a life-saving or pain-killing drug.
      So I see no reason why multiple companies cannot make EpiPens loaded with epinephrine.

  18. I work in Pharma and I hear hospitals complain all the time about the price of my product. And then they mark it up 3x.

    I guarantee you that every hospital that complains to me about pricing makes more money off the product than we do.

    The more clever hospitals will sometimes find ways to get us to charge them more. So their 3x multiple goes farther.

    It’s really unbelievable.

    1. We just got bitched out for using too much Ofirmev. It drives me nuts. They complain about the side effects of opioids, so we use more NSAIDS and then they complain about cost. You can’t win.

      1. You can’t win

        You can’t break even

        You can’t quit the game

        All major life philosophies depend on negating one of the above statements;

        Capitalism says you can win

        Socialism says you can break even

        Religion says you can quit the game.

        -old cynics’ saying

  19. My kid has allergies and we are required to provide a two pack of un-opened EpiPen at the beginning of the school year, along with every other kid that has allergies. I do not doubt the nurse’s office has over 200 EpiPens in storage, all but one or two are unused and then tossed when they expire. In a more reasonable universe you would say your kid has allergies and the school would say, no problem we have a few EpiPens in the event we need them instead of wasting a couple hundred a year.

    1. But then the school would have to budget $1,000 instead of making the parents pay $50k!

      To be fair, each kid has their own script at a specific dosage. They might overlap a lot, but that’s probably beyond the scope of the school’s ability to deal.

      We drop off a few hundred worth of emergency seizure meds.

      1. There are only two dosages, normal Epi-pen or Epi-pen Jr.

        The frightening thing is that they are all stored away from the kid, and in need they will have to sort through the entire collection to find the one with his/her name on it.

        Foolish and dangerous do not begin to describe bureaucracies.

        1. Oh, and an FYI PSA:

          If someone is turning blue from anaphylaxis DO NOT WORRY ABOUT THE DOSE just give them whatever you have on hand.

          And if/when they start to hyperventilate have them breath into a paper bag.

    2. it seems to me that a school nurse ought to be able to use a plain old syringe and bottle of epinephrine and give a suffering child the dosage listed on their medical bracelet or tag. One bottle of drug and a few dozen syringes ought to cover the kids for a full school year. syringes don’t expire,either.

  20. Klobuchar vs. Manchin, steel cage match, no holds barred!

    1. Any way to have both of them lose?

      My wife voted for her last time because “she’s nice.” Every time she bitches about barrycare i remind her.

  21. Gary Johnson crashed through the wall like Kool aid man

    “It’s not capitalism, it’s the regulatory scheme and lack of competition! People don’t actually pay 600 bucks for epipen when take advantage of various vouchers and programs!”

    Wait, that hasn’t happened yet.

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  23. There already is a cheaper alternative.

    Impax Laboratories produces a branded epinephrine autoinjector, Adrenaclick, and also produces a generic epinephrine autoinjector.

    http://www.consumerreports.org…..ternative/

  24. “Epi pens” is tantalizingly close to being a penis anagram. Just saying, as they say

    1. I am guessing “tantalizingly” tells us more about you than we wanted to know.

  25. At those prices it is much cheaper to provide widespread training in the administration of subcutaneous epinephrine. Every EMT in the country can do it. There is little to no reason we cannot train teachers, coaches, lifeguards, restaurant personnel, etc. to do the same.

    Because single dose vials of epinephrine are dirt cheap.

    Ditto for naloxone. Because that is the next thing that is going to be stupidly priced – Evzio.

    1. Exactly this. SubQ has been used by diabetes patients for decades – until autoinjection systems ($$) became available to the general public.

    2. There is excellent reason we cannot train teachers; the typical Teaches’ College graduate is a mouth-breathing idiot who probably doesn’t have opposable thumbs.

  26. Some real competition, my goodness, that is the sort of thing that might upset our elected things gravy train, all the bribery and the assortment of “cumshaw” they thrive on, and so enjoy.

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  28. Since the 1905 Chinese boycott of US goods for morphine dumping, big pharma and government prohibitionists have been the pincers that crush freedom to squeeze blood and money from voters. Children are shot and jailed by rabid prohibitionists on the strength of testimony from expert witness prostitution to protect dangerous drugs whose makers pay revenue bribes to avoid competition.
    Only the libertarian party offers to break the cycle by legalizing relatively safe enjoyable and therapeutic drugs and decriminalizing addictive and politically dangerous drugs (lest they become another corporate industry with equity in purchased politicians). These lying lobbyists’ act, posing before Reason as aggrieved victims of gratuitous government coercion, is as convincing as it is honest.

  29. Part of the company’s solution will be to allow people to order EpiPens directly from Mylan because “more than half the amount paid by the health care system for EpiPens goes to pharmacy benefit managers, insurers, wholesalers and pharmacy retailers, not to the company itself.”

    Given the price increases, this can’t possibly be true.

  30. On another blog,a guy posted the URL for an Israeli company that fills mail-order prescriptions here in the US (legally),and they were charging only $88 for an EpiPen. (which still seems pretty high to me….)

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  33. It was never patents ? it was the drug trials that was the issue
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