US Patients Battle EpiPen Prices And Regulations By Shopping Online (cnn.com)

"The incredible increase in the cost of EpiPens, auto-injectors that can stop life-threatening emergencies caused by allergic reactions, has hit home on Capitol Hill," reports CNN. Slashdot reader Applehu Akbar reports that the argument "has now turned into civil war in the US Senate": One senator's daughter relies on Epi-Pen, while another senator's daughter is CEO of Mylan, the single company that is licensed to sell these injectors in the US. On the worldwide market there is no monopoly on these devices... Is it finally time to allow Americans to go online and fill their prescriptions on the world market?
Time reports some patients are ordering cheaper EpiPens from Canada and other countries online, "an act that the FDA says is technically illegal and potentially dangerous." But the FDA also has "a backlog of about 4,000 generic drugs" awaiting FDA approval, reports PRI, noting that in the meantime prices have also increased for drugs treating cancer, hepatitis C, and high cholesterol. In Australia, where the drug costs just $38, one news outlet reports that the U.S. "is the only developed nation on Earth which allows pharmaceutical companies to set their own prices."

Comments

Logic Says It Should Be Legal

[pubwvj]

It should be legal to order the same product from another country. They're both made by the same company. Stupid trade protectionism.

Re:Logic Says It Should Be Legal

[Impy the Impiuos Imp]

Many on the left love protectionism...except when they don't.

The FDA is no prize -- by being so tightfisted, they prevent politicians from having to explain why a drug hurt people, but this ends up delaying new drugs (and generics, as TFA shows) that trivially causes a lot more harm than they save being overly cautious.

But you know, a death or two in front of the camera is a tragedy the likes of which 10,000 offscreen because of delayed drugs is not.

Re:Logic Says It Should Be Legal

[ArmoredDragon]

Your resident crazy libertarian here:

Indeed there doesn't seem to be any good reason to prevent importing anything from international editions of books (save money for college students) to pharmaceuticals. There may be some merit to that argument for places like Mexico where quality controls are quite poor, however that should be a judgement call left up to the consumer. Likewise, I think the idea of tariffs, embargos, and other forms of mercantilism ultimately cost a domestic economy much more than they supposedly preserve.

Nevertheless, I don't think that's quite the root of the problem. This isn't, by any definition whatsoever, a free market. This is in fact a government granted monopoly. You cannot have both a free market AND a monopoly in most cases. That said, I don't quite understand why we give i.e. patent holders, copyright holders, etc free reign on how, when, where, and how much they can charge for anything with the sky being the limit. There probably should be some system in place whereby if they opt for government protection, then they must follow certain pricing and trade rules in order to keep that protection.

Re: Logic Says It Should Be Legal

[Anonymous Coward]

McDonalds is surprisingly consistent in foreign countries...

Re:Logic Says It Should Be Legal

[jenningsthecat]

Many on the left love protectionism...except when they don't.

Many on the right hate protectionism...except when they don't.

Corporations just love having unfettered access to other markets for their products. They also love unrestricted access to supplies of (cheaper) materials and labour in other countries; but let their customers demand the same, and all of a sudden the hypocritical bastards lobby for protectionism, and start spreading FUD about the supposed dangers of products from other countries. Their idea of a 'free market' is really a 'captive market' - one that is kept captive by the legislation they buy, the lies they spread, and the dirty deals they strike with their counterparts in other countries.

Re: Logic Says It Should Be Legal

[Anonymous Coward]

When my wife was on a particular medication, we used CanadaDrugs dot com to get it vastly cheaper than we could through any USA based pharmacy. The funny thing was, the drug was made in the USA and shipped from a USA warehouse.

The medication was never outside the US borders at all -- but the only way to get a good price was to order it via an international pharmacy.

Re:Logic Says It Should Be Legal

[AthanasiusKircher]

This isn't, by any definition whatsoever, a free market. This is in fact a government granted monopoly. You cannot have both a free market AND a monopoly in most cases. That said, I don't quite understand why we give i.e. patent holders, copyright holders, etc free reign on how, when, where, and how much they can charge for anything with the sky being the limit.

Since there seems to be a lot of confusion in the media about the real issue here, the EpiPen problem (1) has nothing to do with drug patents, and (2) has relatively little to do with patent protection in general.

Just to be clear, the drug here (epinephrine) has been around for many decades and is patent-free. You can easily get a dose of it for a few cents: hospitals directly inject the generic all the time. And the EpiPen is basically out of patent protection. There apparently is still an active patent for some aspect of the device, but the manufacturer settled a lawsuit already that would allow generic manufacture.

So what's the real problem here? There are two. The first is the FDA. Epipens fall under the category of both "drugs" and "medical devices" for approval purposes, and the byzantine set of processes necessary for approval take forever. They also require standards for effectiveness that are probably impossible to meet in this case, because of the high rate of EpiPen (and generic autoinjector) user error. There were supposedly 26 incidents of "incorrect dosage" from Auvi-Q before the recall, but none were actually confirmed and the devices involved did not seem to be malfunctioning. So why the wrong dose?

This is the dirty secret of this whole autoinjector business -- people actually screw up using them quite a bit. (The second issue.) The most common user errors: (1) forget to take safety cap off, (2) use wrong end, (3) don't inject for adequate time (usually recommended for 10 seconds). You introduce a slightly different procedure (with another cap, oh gosh!) and that makes alternatives like Adrenaclick even more likely to be misused.

This whole discussion in the media, to my mind, has been highjacked by people who want to draw attention to the high prices of drugs in the U.S. And that's a very noble goal, because it is ridiculous.

But in this particular case, there is a simple, viable, CHEAP alternative -- a syringe with epinephrine. The primary objections are that people could draw up the wrong dose in a panic or whatever -- but this is solved simply. Have your syringe prefilled by a doctor, nurse, or pharmacist. You'll also hear misinformed doctors saying, "But it isn't guaranteed to be sterile" or "it will degrade." Again, we have research on this issue -- see here and here. Basically, as long as the syringe is stored in darkness (e.g., in a simple tube or something), it's sterile and stable for at least 3 months.

And guess what -- you don't have any of those annoying problems with people screwing up using their autoinjectors. (1) forgot to take safety cap off? Nope -- you actually see the drug go in, so if there's some sort of safety put on the needle to prevent accidental discharge, it'll be clear if you didn't take it off. (2) Used the wrong end? Nope -- even a 4-year-old knows which end of the syringe has to go in. (3) Don't inject long enough? Nope -- again, you see the stuff go in. You push the needle until the pre-measured dose is completely out.

Giving yourself or someone else an injection is not rocket science, and with pre-filled syringes it's probably less error-prone than "autoinjectors." And here's the best part: the total cost is probably about $5 for one (including the syringe and the pre-filling to correct dose). If you were willing to buy syringes and a larger bottle of epinephrine yourself, you could make it even cheaper, but we're already down to $20/year with replacements every

Re: Logic Says It Should Be Legal

[Applehu Akbar]

"Can you imagine if this crap happened with something far more common like insulin injections? "

Actually this same sudden price jump is taking place for insulin, which has been generic for over fifty years. Like Daraprim, insulin is made and sold cheap all over the world - except in the US.

Re:Logic Says It Should Be Legal

[ArmoredDragon]

Since there seems to be a lot of confusion in the media about the real issue here, the EpiPen problem (1) has nothing to do with drug patents, and (2) has relatively little to do with patent protection in general.

IIRC doesn't the patent in this case apply specifically to the mechanism? And yes, epinephrine, for those who don't know, is commonly called adrenaline, which is the name brand of synthetic (but is chemically identical to the endogenous source, and thus no different from it) epinephrine.

And indeed, in many cases when there's a drug monopoly, it doesn't involve a patent. Because I have stage 4 CKD, I have problems with gout. The only medication that effectively treats it in my case is a drug called colchicine. That particular drug has been in use for a few centuries now, but a company presently has market exclusivity. Why? Well, when the Food and Drug Act was passed in 1934, any drug made from that point forward had have its efficacy proven before it could be prescribed, however old medications were "grandfathered in" until a few decades ago (I don't remember the exact year) when the FDA said they needed to pass scientific scrutiny, go through clinical trials, etc, to have their efficacy empirically proven. Colchicine was one of these drugs, and before this happened it was about 10 cents a pill, until the company that put it through its paces was granted market exclusivity as part of their efforts to prove that it works. They then trademarked it under the name Colcrys and raised the price to about $6 per pill.

And again, there is no intellectual property involved here, just the FDA granting market exclusivity. And to a point, I agree with this; they put in the effort to make sure that a drug that's actually by all definitions of the word toxic (it comes from a highly toxic plant) actually works and won't kill you, which isn't a cheap thing to do, they should be able to see a return on investment. But allowing them to raise the price of a drug that is super cheap to produce to a price that's just flat out extortion is ridiculous.

About the only rationale I can figure for avoiding the syringe issue is people's fear of needles

Actually believe it or not I'm less scared of a syringe than an autoinjector. Why? Because in the Army we were issued an autoinjector in case of exposure to some kind of gas (I don't remember which one) which you were supposed to inject into the muscle in your butt cheek. The scary part was how I saw one of these stick right through a 2x4 piece of wood. Imagine if you accidentally stuck your hip bone or your hand...oww...I'll stick with the syringe, thanks.

Re:Logic Says It Should Be Legal

[belmolis]

There's also no reason that autoinjectors could not be modified to have some of the useful properties of regular syringes. For example, if part of the case of the autoinjector were transparent, users would be able to see how much of the drug remained just as with a syringe and thereby avoid partial doses.

Re: Logic Says It Should Be Legal

[ArmoredDragon]

Insulin is harder to fuck up than epinephrine, and if you do fuck it up the symptoms are easier to correct. Epinephrine, by the way, is the hormone secreted by the glands that sit atop your kidneys; most people know it as adrenaline after the name brand of the first synthetic version of it. Also, if you inject a dose of epinephrine standard for prophylaxis treatment into a vein, it'll cause a hypertensive surge that will kill you fairly quickly.

Re:Logic Says It Should Be Legal

[AthanasiusKircher]

1. The school nurse and teachers were trained to use the EpiPen, not your homebrew syringe kit, when your kid has an emergency reaction to errant peanut butter in the lunch area.

Syringes are just as easy to use with 5 minutes of training. Particularly a licensed school nurse should certainly be able to handle that without extra training.

2. Syringes are typically controlled medical supplies here in the United States because they can also be used to inject illegal drugs. They don't just sell empty syringes over the counter and most schools here in the US would probably freak out over "drug paraphernalia" if they spotted your kid with a bag of pre-filled syringes.

Most states do in fact sell syringes over the counter, e.g., for diabetics. Some do put limits on sales to prevent drug use. But all of this is solved by -- ya know -- a prescription, just like you'd get for an EpiPen.

By the way, I guess you just proved my point. Our insane "war against drugs" nonsense is likely why we want to suck hundreds of dollars out of families for no good reason to force them to get the "EpiPen" while refusing to tell them about a cheap, reasonable alternative. Or, worse yet -- the families who go without an EpiPen because of expense or hope that an expired one still works... how many kids are we willing to kill or rush to the hospital with a severe allergic reaction because "ACK NEEDLES!!"

3. Emergency medical personnel are not troubled by the first two problems, but they aren't there when your kid needs them.

If you need someone to actually withdraw a dose from an ampule or vial, be sure to get the proper dose, be sure there's no air bubbles, etc. -- sure I'd agree that paramedics with experience will be better at it in a tense scenario.

But you put a pre-filled syringe in a kit, and it's ready to go. There are some things you need to know (e.g., do NOT inject into a blood vessel, but that's true of EpiPens too), but again that can be covered in 5-10 minutes of training... not significantly more than an EpiPen.

Re:Logic Says It Should Be Legal

[Zontar The Mindless]

That sort of globalisation is intended to provide for unrestricted movement of capital while keeping labour and consumers locked down as tightly as possible.

Re:Logic Says It Should Be Legal

[AthanasiusKircher]

Unfortunately they didn't say that. Those were just lab tests of stability and sterility. In order to be convinced, I'd have to see a study of actual patients who successfully learned to do their own epinephrine injections. That would be a hard study to do, since anaphylaxis is relatively rare.

I never claimed my links said that. They only proved that pre-filled syringes are a viable choice for those people who claim "We can't use syringes because of dosage concerns or worries that people won't fill them correctly or they'll lose time in doing all that for people inexperienced with them." Those things are the reasons always trotted out for why syringes aren't a reasonable alternative, but most of them are solved with a pre-filled syringe... which my links note is a viable way to store the drug until use.

Anyhow, you seriously want a STUDY showing normal people can successfully do an injection?? There are THOUSANDS of diabetics who inject themselves every day in the U.S.

(The other problem was that ephinephrine degrades after 3 months, while the EpiPen lasts 12 months.)

No, do you think the epinephrine in the EpiPens is "magic" or something? It doesn't degrade as fast because it's sealed. Epinephrine in a sealed vial or ampule would generally also last 12 months. Trained medical personnel who are used to drawing syringes quickly in emergency scenarios would have no problem with that stuff. So yes, putting in a pre-filled syringe cuts down the guaranteed stable lifespan. Anyhow, it's easy enough to swap out the syringes on a schedule. Is it less convenient and possible people will forget? Sure. But I think it's also likely some other people are more prone to forget to get a new EpiPen every year, since there's a much longer time between replacements.

My basic reaction to your post is, you can't know that something is going to work until you've done a well-designed study in the real world.

I never said it was guaranteed to be BETTER than an EpiPen -- and for that, I agree it would require a proper study. What I'm saying is that it's a reasonable, inexpensive, and reliable alternative that should be offered to patients who might want to consider alternatives.

Obviously an EpiPen -- used properly -- is probably less fuss and easier. However, I think it's irresponsible for physicians, pharmacists, and the news media to not mention the cheap, simple alternative that is clearly available.

(You also mentioned something about a media source claiming syringes require "extensive medical training" or something... I call BS. Again, diabetics deal with this all the time. There are some precautions, but most are similar to EpiPens, and the additional warnings can easily be explained in a few minutes. You also may want to check into the credentials of that medical professional -- I've seen some media quotes in stories in the past few days saying similar, but it turns out they work for allergy societies that get a huge amount of support from the manufacturer of EpiPens, which at a minimum presents a significant conflict of interest. Please note that many of the major allergy societies have been relatively silent in the past weeks as the EpiPen controversy has grown -- they get a lot of funding from the EpiPen company, so they haven't really been speaking out about what is clearly a patient advocacy issue. Horrifying all around.)

Re: Logic Says It Should Be Legal

[AthanasiusKircher]

Insulin is harder to fuck up than epinephrine

[Citation needed]

Also, if you inject a dose of epinephrine standard for prophylaxis treatment into a vein, it'll cause a hypertensive surge that will kill you fairly quickly.

And if you inject a dose of insulin directly into a vein, it can cause blood sugar to plummet sending you into a diabetic coma.

Yes, the danger of intravenous injection for epinephrine is greater, but there can be dire consequences in either case. In any case, it IS possible to inject accidentally into a vein with an EpiPen too, probably not as likely as with a syringe, but both are perfectly safe if injected into a standard area (most commonly large outer muscle of thigh).

Re:Logic Says It Should Be Legal

[arth1]

Having a crown placed on a tooth with an infection, and prescribing "Neural Therapy" (Fuck, I wish I were joking.)

He probably was, and you missed the punchline that he had to transcend dental medication .

Re:Logic Says It Should Be Legal

[nbauman]

You also mentioned something about a media source claiming syringes require "extensive medical training" or something... I call BS. Again, diabetics deal with this all the time. There are some precautions, but most are similar to EpiPens, and the additional warnings can easily be explained in a few minutes. You also may want to check into the credentials of that medical professional -- I've seen some media quotes in stories in the past few days saying similar, but it turns out they work for allergy societies that get a huge amount of support from the manufacturer of EpiPens, which at a minimum presents a significant conflict of interest.

That "media source" was Consumer Reports. I have checked into their credentials. Their medical reviewers are probably more qualified in each of the specialties than some of the reviewers in the second-string peer-review journals. And they take no money from industry.

Diabetics do inject themselves with insulin, however there are differences between them and people with anaphylactic reactions so you can't equate the two. The most obvious difference is that insulin-dependent diabetics inject regularly, several times a day, so they're used to the equipment and familiar with it. People with anaphylactic reactions might a reaction once in their lives, once a year, or once every few years (according to a friend of mine who did have an anaphylactic reaction to bee antigen in a doctor's office), so they can forget how to use it.

You want to say that it makes no difference. I don't accept that. In a matter of life or death, you need better evidence than your own personal feeling. You seem to know enough about medicine to be able to look up articles on PubMed, but I'm certain that you're not a medical doctor or medical student. The standard of evidence for pharmaecuticals is a lot more rigorous than, say, the flavors and fragrances industry. I'd rather follow the advice of an MD.

It's not good enough to say that diabetic injections are sort of like epinephrine injections, so if it works for diabetes it seems like it should work for epinephrine. The only thing that will tell you what kind of problems come up when people use manual epinephrine injections is a well-designed study of people who use manual epinephrine injections, preferably with a comparison group of people who use the EpiPen. But that would be hard to do, because an anaphylactic shock is such a rare event.

And contrary to what you say, there is nothing in those studies that addresses the claim that "people won't fill them correctly or they'll lose time in doing all that for people inexperienced with them." Those were just lab studies of 2 narrow issues -- stability and sterility.

If you want to understand the design of medical studies, you could read the NEJM, BMJ, and JAMA Internal Medicine (my preferences) over the last few years. If you want to get a summary of what it's all about, you can look in http://www.healthnewsreview.or...

http://www.consumerreports.org...
Can You Get a Cheaper EpiPen?
You could save about $400 per two-pack with generic Adrenaclick and still protect against life-threatening allergy attacks
By Ginger Skinner
August 11, 2016

The DIY Syringe Method

To further cut costs, some have turned to using manual syringes and buying vials of epinephrine to fill them. The drug costs a few dollars per vial. But experts caution that switching to a do-it-yourself syringe is more complicated and can result in getting too much or little epinephrine. What’s more, you’ll need to be trained by a doctor or pharmacist on how to inject the drug quickly and accurately before attempting to try it during an emergency.

And because there are different concentrations on the market, getting the proper dose is critical, especially for children.

Re:Logic Says It Should Be Legal

[dave420]

Yet when we compare outcomes, the US doesn't do that well. Clearly something is up. If you just want to focus on some unsubstantiated claims on Slashdot and ignore the actual statistics, I can understand why you'd be so confused.

Free market is great

[Anonymous Coward]

As long as it doesn't interfere with some rich and powerful company!

Ban drug ad's like most developed nations do!

[Joe_Dragon]

Ban drug ad's like most developed nations do!

Re:Ban drug ad's like most developed nations do!

[Anonymous Coward]

I left the US right about when they were starting to be allowed. Now when I go back it's pretty disconcerting, bordering on revolting, to see how much tv space is taken up with drug ads.

There is no reason for drug ads. Period. Drugs should be allowed by efficacy and safety, priced honsetly and prescribed by qualified unbiased doctors for the conditions they treat best. None of that is true in the modern US of A

Hooray for overseas mailorder

[glomph]

My Telmisartan (technically generic now, but Big Pharma is delaying it) is 6x cheaper overseas. Fuck the corporate kleptocracy and their politcal enablers with a rusty rake.

State of Minnesota reccomends Canadian Pharms

[laughingskeptic]

They even had a state website that pointed directly to Canadian pharmacies for several years: http://www.amednews.com/articl... . I used their list to choose my Canadian pharmacy and still use them when it makes financial sense.

Re:Free market

[Anonymous Coward]

You're aware that the senator whose daughter is CEO of Mylan is a Democrat, right? Greed isn't a left nor right issue. It's not a conservative nor liberal issue, it's a people issue.

Re:Free market

[JaredOfEuropa]

This is not a free market. In a free market you'd be free to buy from overseas companies.

LMGTFY

[Tailhook]

Someone look up the D's and R's please. Since they were omitted I'm betting the father of the CEO is a (D).

Re:LMGTFY

[Knetzar]

Good catch.

From the article: One Democratic senator whose daughter has allergies has called for action and another Democratic senator's daughter is CEO of the company responsible for the price hike.

Asthma Inhalers did a Similar Money Grab

[Anonymous Coward]

This is similar to the price hike for asthma inhalers.
The excuse was to eliminate CFCs and save the ozone layer.
There is not even an attempt at government control.

All these pharma/insurance stories

[fustakrakich]

And still insufficient demand for universal health care. And don't blame the politicians. With the upcoming 95% reelection rate (and 100% republican/democrat monolith), there is no incentive for them to change anything. The only issue monopolizing the media is *he who shall not be named*

Re: All these pharma/insurance stories

[Anonymous Coward]

Bullshit.

What the fuck is it with you idiots ? Are you all truly incapable of opening your fucking stupid eyes ???

Universal healthcare delivers better outcomes at lower costs than the US system of third world medical care.

The rest of tje developed world laughs at you. They are healthier and live longer than you and dont go broke for having the temerity to get sick.

I have American friends who schedule health care during their trips to Australia as even paying full price it's vastly cheaper than the US, of superior quality, and they're not turfed out of the hospital after one day to free up a bed.

Wake up to yourselves. You're paying new BMW prices for a smashed up 1995 Taurus.

Re: All these pharma/insurance stories

[inode_buddha]

Bill shot and fud. Tell me why the Scandinavian countries and the Germans have probably better outcomes for less, with none of the scare points you're so sure of. Yo do realize that everyone can get paid just fine working at a non profit right? And no, Obamacare isnt even close to universal healthcare unless you're a tool of Fox news. Do you really believe Obama is socialist or something? His whole healthcare plan was a right wing gimme be cause he is fundamentally right wing regardless of the D after the name.

Re:Free market

[_Sharp'r_]

Yeah, the Obama FDA, that hotbed of conservative activism!

Also, since when was price fixing by governments a "free market" solution?

You make it sounds like the Democrats are in favor of free trade from online pharmacies, when a quick Google search and clicking on the first link is enough to dispel that.

I'm not saying there aren't government-lovers on both sides in this area, but to cast it as 'the "conservatives" are against a free market, and the "liberals" are for the free market.' when it's more the opposite is quite a stretch there...

Epinephrine cost per dose in about 50 cents

[ITRambo]

Epi-pen dosage is 0.3 mg of epinephrine. One dose from a Primatene mist inhaler releases 0.22 mg of epinephrine, exactly the same active ingredient as an Epi-pen. There are over 60 doses per Primatene mist inhaler. at a cost of about 50 cents per dose. Several years ago Primatene Mist was removed from the market. Our health care system is now fully controlled by corporations that don't give a rat's ass if we live or die as long as their profits continue to skyrocket, at any cost. Health insurance companies could fight back. But they don't appear to care, as they just raise their rates to cover the excessive and escalating cost of life saving prescription drugs. Having asthma, and having worked with suppliers of delivery mechanisms during my career, I estimate the cost of goods sold per Epi-pen is about $2 to $3 each. Any figures beyond that are profit. Any higher CGS presented by Mylan, should they choose to do so, are likely accounting techniques where they move ongoing R&D costs onto old and fully paid for products. The retail price of Mylan's Epi-pen is legalized theft such that Al Capone would be proud.

Re:Epinephrine cost per dose in about 50 cents

[Dorianny]

The biggest problem is that Medicare the largest insurer in the country is bared from both negotiating prices with Drug manufacturers as well as weighing its cost when considering approval of medication

Re:Epinephrine cost per dose in about 50 cents

[hey!]

Well, it's the very fact that the alternative is, possibly, death that makes it possible for a company to do this. This thing occupies a peculiar corner case where the demand is modest, but inelastic.

This means a monopolist can milk the market by raising the price to insane levels, but because the market is small no competitor wants to enter it. Were the market to become competitive it is so small that the newly entered competitors wouldn't make much off their efforts. This is contrasted with statins, which are blockbuster drugs. You don't need a very large slice of that pie for the slice to be very large indeed.

The same thing happened last year with Duraprim. If you have toxoplasmosis, you absolutely have to have it. But how many people get toxoplasmosis?

Re:Epinephrine cost per dose in about 50 cents

[JBMcB]

Several years ago Primatene Mist was removed from the market. Our health care system is now fully controlled by corporations that don't give a rat's ass if we live or die as long as their profits continue to skyrocket, at any cost.

Primatene Mist was banned by the FDA in 2011 because it contained CFCs.

http://hubpages.com/health/Wha...

Do you have evidence that Primatene wanted the FDA to pull their product off the market?

Re:Epinephrine cost per dose in about 50 cents

[Wrath0fb0b]

I estimate the cost of goods sold per Epi-pen is about $2 to $3 each. Any figures beyond that are profit. Any higher CGS presented by Mylan, should they choose to do so, are likely accounting techniques where they move ongoing R&D costs onto old and fully paid for products. The retail price of Mylan's Epi-pen is legalized theft such that Al Capone would be proud.

Al Capone and his bootleggers were largely in favor of prohibition ($$$) and opposed to its repeal. They were also (violently) opposed to their competitors trying to move alcohol outside their protection racket. You want to fuck Mylan over, stop making it difficult for their competitors to compete with them

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.

The only shocking thing is that the price didn't go up more when a field of three competitors was narrowed to only one that's given a legal monopoly over the whole market.

Re:Epinephrine cost per dose in about 50 cents

[Zxern]

Oh there are plenty of costs behind the Epi-pen price. It's just that most of them have nothing to do with actually making it. The highest costs are in marketing and lobbying.

Lobbying for purchase requirements, Lobbying for generic fda rejections, marketing to create extra demand. That doesn't come cheap.

Re:Free market

[93 Escort Wagon]

Both conservatives and liberals love their broad, simple talking points - but, in the end, there are lots of things that don't fit neatly into just one box. Many, many issues in life are just inherently complex. So, when there's conflict, a person has to weigh which conflicting principle Is more important to them.

Plus it's only natural that we are predisposed to be more sympathetic towards a position which either impacts us directly or affects someone we care about.

Re:Free market

[geekpowa]

Even if you are allowed to buy from overseas, you are not, strictly speaking, operating in a free market. You are relying on 'anti free-market' government measures and protections in the target jurisdiction. Carry idea of free market to it's ultimate logical conclusion, medicine from overseas will still be expensive if certain people had their way and this loophole would definitely be closed to you. Using Australia as an example, it is actually illegal to export government priced/subsidised medicines from Australia. It is supposed to be for Australian citizens only. Citizens leaving australia need to demonstrate any medicine they are carrying is for their own personal use.

All this reveals one of the many faults and limitations of libertarian-ism / small government ideology. It assumes that in all transactions all parties have equal agency. Which is never ever the case when your life and health are part of that transaction. Sometimes people need to organise help protect themselves from the ruthless practices of greedy arseholes. At least as far as medicine is concerned, the rest of the developed world gets it...

Government Enforced Monopolies

[Anonymous Coward]

Epipen has no domestic competitors because the FDA (government) says so. It can't be bought from abroad because the government (FDA) says so. The solution isn't to mandate pricing, it is to streamline the process of delivering a well understood drug (adrenaline) at a well known dose, in an exactly known situation. It would be trivial to bring generic competitors to market if this were a reasonably governed area, and there would be no price gouging allowed because they couldn't sell it at even what the price was before the jacked it up. (Adrenaline aka epinephrine is trivially cheap, and the injector is quite cheap to make as well.)

I don't normally swear online

[Kobun]

But why in the FUCK are companies being granted effective monopolies on generic drugs?!?!

Nice to know our 'representatives' don't feel the need to hide it anymore. They've been in bed with the drug companies for a long time. But seriously, this takes it to the level of Muppets-style puppetry. No one believe that Kermit is a real frog; we all know that he's got an arm buried up his backside. Do you think Congress gets a bulk discount on shoulder length calving gloves and jugs of lube?

Conflating several issues here

[Etcetera]

Arguably "the same drug" will be the same everywhere, but if you're ordering online drugs from somewhere outside the FDA inspection regime, you don't know what your chances are that it's in fact actually "the same drug". Really, you don't know what you're getting.

That's still a possibility here, of course, but when a US producer commits fraud you'd better believe you'll have an army of lawyers beating down your door to help sue them into oblivion for it. Random Joe Bob's Discount Drug Shack operating in Singapore? Good luck.

Secondly, the FDA approval process itself. For better or for worse, having a complex medical trial and many layers of approval is probably better that not having it, in terms of protecting US consumers from unsafe foods and drugs. There's a fast-track process for promising drugs and devices to prevent dangerous conditions, and there registered experimental treatments, but all other things being equal, I'd prefer to know that some basic level of testing was done.

Drug IP process. People in other countries like to point out that they can purchase drugs for $20 that are charged higher processes here. You can thank us (the American Consumer) for that. Not everyone gets to be a marginal consumer.. and part of the reason we're paying full price for drugs is so that the market incentive allows those drugs to be developed in the first place. Without market incentive, you're only going to proceed in research as fast as centrally-planned authorities dictate you will. Or you're a charity, funded by donations.

None of those things directly deal with device IP, but to be honest cases like this (where someone is being an abject douchebag) are rare, and tend to get discovered, highlighted, and corrected through social pressure. (EMT's have been talking about the cost of EpiPens for years, and there were already initiatives under way to allow EMT's to inject Epi directly: http://thesouthern.com/news/local/govt-and-politics/new-state-law-will-allow-emts-to-inject-epinephrine/article_42dbddd9-a035-509b-b99a-7f720c7411b0.html

The measure, sponsored by state Sen. Chapin Rose, R-Mahomet, and signed into law by Gov. Bruce Rauner late last week, comes as the maker of the EpiPen is facing increased scrutiny from the federal government over dramatic price increases for the lifesaving drug. The cost of a two-dose package of EpiPens, made by pharmaceutical company Mylan, jumped from less than $100 nine years ago to more than $600 in May, The Associated Press reported Wednesday.

While the timing is a coincidence, Rose said recent attention from Congress has attracted the public eye to an issue that was first brought to him by a rural fire protection district he represents.

If there's a justifiable reason for a price hike, it'll become public as well. Often there is. E.g., a critical component has restricted availability.

Re:Conflating several issues here

[thegarbz]

Random Joe Bob's Discount Drug Shack operating in Singapore? Good luck.

Random Joe would be bound by the inspection rules of the Singapore Health Sciences Authority (HSA) which serve a similar purpose as the FDA as well as be registered with the Singapore Pharmacy Council (SPC). Now if these sound like shady organisations it's because the FDA has a formed a joined working group with the HSA to ensure that all drugs available in Singapore and the USA meet the requirements of both countries as required by the trade agreement that is in place. i.e. Your government's agency charged with protecting you think that their government's agency charged with protecting them are equally capable and do the same job.

I'm glad you chose Singapore. It shows both your prejudices against the east as well as your complete ignorance of the pharmaceutical industry outside of the USA where, not only are the drugs of comparable quality but people are less likely to die as they can afford them too.

Quit whining - your doctor can prescribe epi

[lightperson]

A 1 ml ampule of epinephrine costs about $5. An insulin syringe about 25 cents. That is enough for three normal epi-pen doses - more than enough for any emergency. Sensitive hikers carry this. Folks working around bees and wasps too. If your doctor won't prescribe it, find a doctor who will. Of course you will have to learn to break the top off the ampule and fill the syringe up, getting rid of little bubbles. The rest is the the same. The only reason epi-pens are an issue is because many, perhaps most people are accustomed to Big Pharma and insurance companies leading them to believe that they will take care of them, but only if they stop thinking for themselves.

Monopolies

[markdavis]

>"the U.S. "is the only developed nation on Earth which allows pharmaceutical companies to set their own prices."

There is nothing inherently wrong with a free market..... as long as the market really is free and isn't being controlled by unregulated monopolies. That is what we are seeing happen with things like the Epi-Pen. And in cases where patents are creating artificial monopolies, we have to examine if there should be regulation (as we rightfully regulate all other monopolies).

As for the backlog at the FDA for generics- that is just inexcusable.

Oh, and yes, I am one of the people that must have an Epi-Pen or risk losing my life if I accidentally eat a nut (which happened once and nearly did so). So yes, I have a horse in this race...

Re:Who's stopping you...

[ArtemaOne]

Possibly customs if they catch you breaking the law with the illegal import.

Re:Free market

[KiloByte]

There's no market when only one company is allowed to sell the good.

Re:UK Cost of EpiPen

[gb7djk]

You may find this manufacturer's comparison page useful.

Re:IP law has nothing to do with logic.

[Calydor]

No one said the company isn't allowed to turn a profit - but as a patient, do you want the sole supplier of medication that keeps you alive to suddenly realize they are the ONLY REASON YOU ARE ALIVE and bumping your daily expense up to a million dollars?

Re:UK Cost of EpiPen

[jedidiah]

There is a government supplier of Epipens. The tech was originally developed for the military. So they have their own license. Epipens made for the Army are $50.

The private market supplier isn't just making a slight bit more profit. They're making 10x for a product that has been around for about 20 years already (if not longer).

This is more like aspirin than Gleevec.

Re: IP law has nothing to do with logic.

[Anonymous Coward]

Um. Dude. You might want to look around, this site is largely due to the existence of free software. FREE. People do it and give it away for FREE.

You just can't fathom value being non-monetary which makes your economic-fu weak. Homo econicus ain't no fool, Homo Economicus has gradients of preferences, in relation to and driven by a variety externalities, which regardless of your mental capacity to comprehend them exist. Right now. In you, your inner homo economicus, is erupting with complex value calculations that you are probably to ignorant to clearly understand.

You should stop being so hung up on money, and let your inner homo economicus run free. Enjoy all your preferences, not just the ones society shows you will satisfy you.

A big secret I learned a long time ago, that sort of makes this all work, is that by helping each other (think free shit) we get along better in the universe. It actually makes us happy and fulfilled. What?! That is our most selfish center is, is best satisfied by caring about helping other humans?

That sounds fucked up. Real fucked up... But shit that does make some fucking sense. It's probably our evolutionary edge, because there ain't no fuckin way we out predator'd everything else on this planet lone wolfing it for a few million years... That and thumbs.

Thumbs are no fucking joke.

Re: IP law has nothing to do with logic.

[riverat1]

Without personal gain, shit just doesn't get done. You don't work for free. Why do you expect anyone else to.

As a real patient, I would rather the entire the entire industry not be destroyed either by crass idiots or morons with "good intentions".

The issue isn't that simple and there's a lot at stake that you're blissfully unaware of.

Sheesh! The Epi-pens cost less than $50 in materials to make and yet the maker wants to charge over $300 apiece for them. The only way they can get away with it is by having an exclusive license to sell them in the USA. The only reason they can get away with it is they have no competition.

Re:IP law has nothing to do with logic.

[JoeMerchant]

Well, libertard (please take that in fun, as it was intended) your real problem in this world isn't actually the FDA, it's the insurance industry. The FDA may be able to shut down businesses which don't comply, but, by and large, they let an awful lot of stuff get through. It's the insurers who are deciding what actually gets used in our medical system - drugs, devices and procedures they are willing to pay for are widely used, those they do not are relegated to a tiny fraction of the market. FDA doesn't actually "approve" anything, they give "permission to market." It's insurers that "approve reimbursement," and insurers who have built up a system so corrupt that when it is studied in history, people will not believe the ratios between private pay price and insured reimbursement. It simply won't make sense that a society that supposedly had a free and open competitive market, with laws against monopolistic behavior, could ever allow billing $15 for a 500mg Tylenol pill, or $15,000 for a device with 30 year old technology inside that costs $500 to make.

The only other time I ever encountered "prices" that were so crazy was in former East Germany, just after the wall fell 1990: Bread: $0.05 per pound, nice 3 bedroom flat in town: $12 per month, bicycle (luxury item) $15,000, color TV $45,000. It turns money into a sick joke. Just like in the USA today, when you get really sick, the money involved is beyond crazy, all you can do is laugh and shake your head, oh, and pay the man if you want a chance to live.

Re:IP law has nothing to do with logic.

[Applehu Akbar]

No, the FDA's power to keep products off the market is the problem. The health insurance industry only has the power it enjoys now because it's the patient's only bulk bargaining agent in the current monopoly environment. Except for major medical like heart problems and cancer, the industry isn't even functioning as true insurance - it's just a prepayment system with bargaining power.

The real price of any medical procedure, device or compound is the contract price the insurance company pays for it. Unless you're on Medicare and get a regular EOB statement of payments, patients never even know what this contract price is. As an example, my wife's kidney dialysis sessions are billed out at $3,925 each, for a total of about $600,000 per year. The insurance company's "real price" is $290 per session.

If we had a competitive market in medicine the importance of insurance companies would diminish. Health insurance would go back to being the "major medical" it once was, indemnifying us against hospital stays and catastrophic diseases. The governments and charities which pay for medical services now would save correspondingly, which alone is why competition will be forced on the industry as prices become intolerable.

Re:IP law is not involved in this case

[nbauman]

The solution: Change the FDA. Make it cheap and fast for a drug manufacturer to get approved to make any drug if they can prove that they are using industry-standard (or better) processes for quality control and if they are producing a chemically-identical product.

And exactly how do you propose to change that? Do you want FDA employees to work longer hours? Or do you want them to work twice as fast in the same hours? Can you speed them up like a tape recorder?

Actually, the FDA does a pretty good job right now. They approve drugs faster than European regulators. They had a backup several years ago when Congress (actually, Republicans) thought it would be a great idea to cut taxes and cut the budgets of government agencies.

I remember the CEO of a biotechnology company (I think Centicor) complaining that the FDA inspector couldn't come to his plant because they didn't have the budget for the train fare on Amtrack.

FDA regulation has little to do with why drugs cost so much money. More important is the Republicans refusing to let the government negotiate prices with the drug makers. https://en.wikipedia.org/wiki/...

In the UK, they have an agency, NICE, which decides how much the drugs are worth, which is often half or a third as much as the US price.

Re: IP law has nothing to do with logic.

[nbauman]

It's not just an exclusive license. They passed laws requiring schools to buy them.

Heather Bresch, Mylan's CEO, whose father is a congressman, managed to get Congress to pass a law effectively requiring every school in the country to stock an automatic injector, of which EpiPen is the only one readily available.

Re:IP law has nothing to do with logic.

[nbauman]

As an example, my wife's kidney dialysis sessions are billed out at $3,925 each, for a total of about $600,000 per year. The insurance company's "real price" is $290 per session.

Well, the original intention of Congress was to have free market competition in kidney dialysis, to bring the price down, but that didn't work. There were a lot of small providers but a couple of big companies took over the industry and turned it into a monopoly. You can't negotiate prices with a monopoly.

It seems that in the modern economy, the free market doesn't last long as many industries turn into monopolies. Amazon is a book-selling monopoly. Google is an internet advertising monopoly.

If we must have a monopoly, we might as well have the government running it.

Re:IP law has nothing to do with logic.

[Zontar The Mindless]

...[Y]our real problem in this world isn't actually the FDA, it's the insurance industry. The FDA may be able to shut down businesses which don't comply, but, by and large, they let an awful lot of stuff get through. It's the insurers who are deciding what actually gets used in our medical system...

Tell me about it. My mother has cancer. Her physician-recommended treatment isn't covered by insurance because they consider it "experimental", despite the fact that it seems to have worked quite well for Jimmy Carter.

Re:IP law has nothing to do with logic.

[tburkhol]

The health insurance industry only has the power it enjoys now because it's the patient's only bulk bargaining agent in the current monopoly environment.

Except that the insurance industry has no motivation to control costs. They run, essentially, as a cost-plus provider, meaning that their profit margin is some percentage of whatever the cost of care. If the cost of drugs goes up, the insurance company doesn't "eat" that cost, they raise premiums.

Economics of intellectual property

[RobertJon]

Provocative line: “The US is the only developed nation on Earth which allows pharmaceutical companies to set their own prices.” Of those 18 provocative words, the most egregious is “allows.” http://www.abc.net.au/news/201... That presumes government owns all property, real and intellectual, in which it magnanimously “allows” us a share, but only as it, government, please. That further presumes that government itself is not the cause of the problem in the first place. Both of those presumptions are wrong, to our great harm. To make this simple, I lay the matter out in clear terms below. That way we can begin discussions wherever it is that you first disagree. Free markets work best to allocate scarce resources. For free markets to work, certain premises are required: many small, independent agents; free flow of information; no distortions such as tariffs, barriers, monopolies The proper role of government is to ensure those premises. Instead, government chooses to meddle directly, and inevitably makes things worse. This is known as iatrogenic disease. In particular, private monopolies are not an issue today. All private monopolies fail: someone always cheats, or defects; substitutes arise; technology advances; fashions change. And if a monopoly should arise, we have a vast apparatus in the US, between the Department of Justice and Federal Trade Commission. (Not that those folks have a good track record, viz. AT&T, IBM, Microsoft, Apple, Amazon Indeed when he was six, my son asked a challenging question, “how can it be a monopoly if it’s something you don’t need?” I wonder.) Today, private monopolies cannot arise. With modern technology, international trade and global markets, they are simply infeasible. No, the only durable monopolies are those imposed by government, because government first holds the monopoly on violence. Now some government monopolies are good, and temporary. Copyrights, trademarks, and patents are in the US Constitution. Others, not so much. That latter includes all the frauds amongst cronies and politicos. That category is the worst violation of free market premises ever, and the one most perpetrated. Cronyism has done orders of magnitude more damage to the US economy than any other violation, including insider trading. As to patents, a primer on the economics. Invention, like any other good or service, must be rewarded in order for it to be produced. Unlike goods and services, intellectual property is peculiarly subject to theft. So government gives inventors standing (term limited) to protect their property with civil remedies. That patent is like a lottery ticket. The inventor tried 10 things. Lost his investment of time, effort, and cash in nine of them. The tenth thing seems to work. Now he must make enough on that tenth thing not only to reward that effort, but to recompense him for the other nine as well. Say the 10 ventures cost $100,000 each. That means the tenth winner must return AT LEAST $1 million. Quite a bit more, in fact, because government comes around to seize its taxes first, and after that, the inventor must do more than break even. That’s the social contract. Before the fact, the politico promises the productive person if he takes risk and makes something that works, he can cash in that lottery ticket.” But after the fact, the politico hypocritically turns all populist and say “I don’t feel that $1,000,000 is merited. I feel $500,000 is more than enough” Who the (trigger warning) is that politico to decide market value? How dare that politico feel it’s up to him to “allow” one price rather than another? Is the patent valid? Then do not violate the terms of the deal. Is there no other competition? Then tell the (trigger warning) FDA to do its job. Is the IP such that people really do need it, as my son asked?

Re:IP law is not involved in this case

[silentcoder]

Erm... based on your username, I'm going to assume you were completely high when you wrote that piece of utterly ahistorical crap.
Sorry the shutdown was the republican's fault and their demands had NOTHING to do with the Obama-care website, they were demanding the defunding of the entire Obamacare law (effectively repealing it without a repeal).

No president would ever agree to terms that means shutting down his signature legislation because congress is trying to blackmail him - Obama called their bluff believing they were not actually *insane* enough to go ahead with the crazy shutdown plan.
What he didn't plan on was that, at this time, the so-called "freedom caucus" (teaparty anti-government nutjobs who somehow got into government as opposed to the backwoods dumptruck graveyards they belong in - these guys made Ron Paul look like a fan of big-government) had enough power over the rest of the republicans to force them into it. Those nutjobs genuinely believe the very existence of the federal government to be an unholy satanic crime against god (no, I'm not exagerating) so they were quite happy to see it all shut down since that was literally the purpose for which they ran: they ran in ORDER to be able to shut down the government. Their only regret about the shutdown is that it ended, they wanted that to be permanent and saw the budget fight as an opportunity to show that it can be done and thought everything would work so much better with it down that voters would demand it become permanent... their experiment failed, it was an unmitigated disaster for the country and the republican party rightfully got blamed.

What really makes this stand out is that the entire freedom caucus at the time was only 44 members - that's about 10% of congress who somehow managed to get all the rest of the republicans so scared that they went ahead with the shutdown despite being relatively sane humans who knew it was a crazy idea. A bit like Paul Ryan "supporting" Trump now.

Sorry pal, you can't just rewrite history to make everything Obama's fault. I know republicans blame him for everything bad that ever happened up to and including 9/11, Hitler and original sin but it just doesn't make sense to blame a president for things that happened before he was elected or against his wishes. You want to be mad at Obama - blame him for the actual bad stuff that DID happen on his watch. Blame him for the extralegal and unconsttutional fuckup known as the drone war, blame him for the expansion of NSA spying on his watch - blame him for having a penis so much bigger than Trumps that he never once felt insecure enough to make it a subject of political debate... but don't make shit up.