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Feds Go After Mylan For Scamming Medicaid Out of Millions On EpiPen Pricing (arstechnica.com)
An anonymous reader quotes a report from Ars Technica: Over the nine or so years that Mylan, Inc. has been selling -- and hiking the price -- of EpiPens, the drug company has been misclassifying the life-saving device and stiffing Medicaid out of full rebate payments, federal regulators told Ars. Under the Medicaid Drug Rebate Program, drug manufacturers, such as Mylan, can get their products covered by Medicaid if they agree to offer rebates to the government to offset costs. With a brand-name drug such as the EpiPen, which currently has no generic versions and has patent protection, Mylan was supposed to classify the drug as a "single source," or brand name drug. That would mean Mylan is required to offer Medicaid a rebate of 23.1 percent of the costs, plus an "inflation rebate" any time Mylan raises the price of the brand-name drug at a rate higher than inflation. Mylan has opted for such price increases -- a lot. Since Mylan bought the rights to EpiPen in 2007, it has raised the price on 15 separate occasions, bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007. That's an increase of more than 500 percent, which easily beats inflation. But instead of classifying EpiPen as a "single source" drug, Mylan told regulators that it's a "non-innovator multiple source," or generic drug. Under that classification, Mylan is only required to offer a rebate of 13 percent and no inflation rebates. It's unclear how much money Mylan has skipped out on paying in total to state and federal governments. But according to the state health department of Minnesota, as reported by CNBC, the misclassification cost that state $4.3 million this year alone.
The pricing structure is a complete scam, and they outright lied to congress on the profit margin.
Make your own EpiPen clone, the EpiPencil.
The company claimed on official government forms for multiple years that the drug is a generic. Make it so. Job done. The government can do that.
Learn to love Alaska
ban drug ad's on tv!
grumpycatgood.jpg. Send the CXX suite to prison for a few years, fine then the millions they made on the scam, and maybe it will slam on the brakes to other companies jacking up the price of generics that were discovered 50 years ago.
Yeah... I get the distinct impression that this is mob justice at its finest.
As I understand the story, the other major competitor was unable to show test results that their autoinjector worked reliably, and as such lost their FDA approval. If I'm to believe that descriptions mean anything, the product would certainly fit the "non-innovator multiple source" category.
You do not have a moral or legal right to do absolutely anything you want.
Peasant, don't you realize that Mylan is run by a Democratic Senator's daughter? Your lowly kind is not allowed to criticize the royalty of the exulted overclass! Grandees like Manchins or Clintons are not subject to your grubby "laws," nor are their gets.
Know your place!
The Mylan brand Fentanyl patch has jumped to $45 per patch, it doubled in price a few years ago with the BS excuse that there was a shortage. I have to get generic now which only costs $10 per patch because my insurance won't cover it.
Unfortunately the FDA has evolved into a highly corrupt organisation, so the fact that the FDA didn't approve a competitor's product doesn't mean it was unsafe.
The CEO of Mylan is daughter of a senator, and that could explain a lot.
Now the public opinion has turned against them, and rightly so, and after the chance she has got during the hearing to explain things and to offer improvement, it is very good that her total lack of empathy for the patients, her customer base, is followed up by the FEDs investigating inappropriate financial behaviour, of which she has been warned many times by the authorities.
"Trump!!", the new Godwin.
"bringing the current list price to $608 for a two-pack up from about $50 a pen in 2007. That's an increase of more than 500 percent," Is my math wrong or should is that increase more like 1200%?
$4.3M in fines... Lets see, increase the price of EpiPens by $200... Report it as a "research investment"...
I'm not sure what all the fuss is about regarding the profit on a medicine and why Mylan would need to lie to congress or anyone else regarding its profit. If they have a patent on a product the company can charge what ever they want and if folks don't want to pay the price they don't have to buy it. In our economy there are many products where the cost of purchase has little relationship to the cost of manufacture. Other examples in the pharmaceutical industry are rampant including those of Martin Shkreli (see https://en.wikipedia.org/wiki/...). There are two examples cited where the price of drugs purchased by companies he was associated with were raised 5,556% (the antiparasitic Daraprim) and 2,000% (Thiola). The price of the second has not been reduced even though Shkreli was removed from the company. Not sure about the first. These prices made a lot of money for the companies, its share holders and the senior executives. Isn't that what capitalism is all about?
In a time of universal deceit, telling the truth is a revolutionary act. George Orwell
As much fun as it is to use Mylan as a punching bag these days, there's a final point in the Ars article that leads me to think this is hardly in the bag for the Feds.
And if that's true - that Medicare was already applying the âoenon-innovator multiple sourceâ rebate schedule to the EpiPen back in 2007 - then that makes this case a lot murkier. The Feds would then have to make a case as to why the drug can and should be reclassified at the higher âoesingle sourceâ tier. It's clear that in practice the EpiPen is a single source device, but the conflict at the heart of this is one of bureaucracy and not medical practices; the Feds would need to justify both the higher rate now, and why they're not culpable for approving the lower rate in the first place.
Given how long that this is going on, I suspect that this isn't an easy case to prove, otherwise the Feds would have done it already. Instead it's probably being brought back up now to either apply additional pressure to Mylan, or to strike while the political iron is hot.
Or, it could be not malice, but mere stupidity.
It seems there's been a series of unfortunate events affecting Mylan's competitors:
Will anyone ever give Mylan’s ($MYL) blockbuster epinephrine injection, EpiPen, a run for its money?
That’s the question now that another potential competitor is out of the running. The FDA stiff-armed Adamis' ($ADMP) prefilled epinephrine syringe, asking for more data. Regulators want the San Diego-based company to expand a patient usability study and product stress testing studies included in the original application.
The way Evercore ISI analyst Umer Raffat sees it, Adamis’ product wouldn’t have been “a large competitor” for EpiPen, given the difference between its prefilled syringe and Mylan’s more convenient injection pen device. But “Adamis could have added to managed care pressures,” through its stated strategy of acting as a discounted product.
Instead, Mylan is home free--a status it must be getting used to, given the failures that have repeatedly befallen its competitors. Back in November, Sanofi's ($SNY) Auvi-Q hit a wall, when an injector fault triggered a hefty recall. Ultimately, the pharma giant yanked Auvi-Q from the market, and then bailed on its marketing partnership with developer PDL BioPharma ($PDLI), putting the med’s future up in the air. It was EpiPen's first real challenger in years.
More recently, the FDA handed generics giant Teva ($TEVA) a rejection for its generic version of EpiPen, flagging “certain major deficiencies” in its letter to the Israeli pharma. With serious issues to work through, Teva said earlier this year that it expects its product to be "significantly delayed"--meaning it doesn’t expect a rollout before 2017.
The FDA wouldn't have anything to do with the recall, and a request for more information isn't really a particularly effective use of corrupt power. Requests for more data happen all the time, so they're usually turned around pretty quickly. My money's on a perfect storm of chance events, and Mylan's taking the opportunity to capitalize on it.
You do not have a moral or legal right to do absolutely anything you want.
All, current government price for 1 box of EpiPen is $212 dollars. This is the VA/DoD contract pricing which is devoid of additional rebates only our wholesaler markup. Therefore, Mylan gets about $200 from each DoD script. So their profit on retail is double that of DoD/VA.
~DoD Pharmacist Manager
The fact that Mylan can charge these prices is government regulations and government-granted monopolies.
And it's hardly surprising why Mylan got this monopoly on a silver platter: they are politically well connected (with Democrats in this case).
Die. Die in several fires. With vigor and fervor. *cockpunch*
In a world of the blind, the one-eyed man is king--and the two-eyed man is a heretic.
That CEO was basically given a degree because of her father's political ties. https://en.wikipedia.org/wiki/...
Only the State obtains its revenue by coercion. - Murray Rothbard
And if that's true - that Medicare was already applying the âoenon-innovator multiple sourceâ rebate schedule to the EpiPen back in 2007 - then that makes this case a lot murkier. The Feds would then have to make a case as to why the drug can and should be reclassified at the higher âoesingle sourceâ tier. It's clear that in practice the EpiPen is a single source device
Is it clear? There are other options out there (e.g. Adrenaclick), if you get your doctor to prescribe an "epinephrine autoinjector" instead of specifying "Epipen" by brand name. How different is that from other drugs? If you get a prescription for, say, Lipitor, can you fill that with a generic? Or can you only do that if you get a prescription for atorvastatin rather than the brand-name?
http://www.consumerreports.org...
rage, rage against the dying of the light
When you quintuple the price of an already expensive, widely purchased, life-saving device that is paid for largely by Medicaid and Medicare funds, you should expect that the government that is paying for your device will take notice and comb through the salient documentation to see if there is some possible legal problem with your price increase. Had the government not done so, we'd all be screaming that they were negligent in their financial oversight duties.
Really, these guys are just a different type of patent troll.
That list of problems with competitors fails to mention Impax's Adrenaclick, which has been FDA approved and sold in the US market freely since 2010; it's widely available (it's sold at Rite Aid, Walgreens, CVS, Walmart, Target, etc) and much cheaper than EpiPen.
rage, rage against the dying of the light
No it's not generic. Yes it should be. But the FDA approval rolls up the drug and the dispenser and the generic versions of the Epipen have not been approved. There are other makers that do provide epinephren auto injectors but they have their own systemic approvals. So while it should be a generic, the very fact that no generics can get approved means it's not generic. Mylan of course knows this. I'd be unsurprised if they were behind creating unneccessary specs just to fail the generics.
Some drink at the fountain of knowledge. Others just gargle.
these clowns should get crucified for basically holding the public hostage
1 RICO charges should be filed against the company and the execs (i think its called separately and corporately liable??)
2 the IRS should do a full bore forensic audit on the paperwork for the last 7 years
3 the company should be required to pay back every penny plus 25% of the increase
4 their entire patent portfolio should be wiped and they should be required to assist any company currently in the same or semi related market on building a duplicate (in fact those patents should become PD)
if this does cause the company to become bankrupt then the Execs should be bared from any medical business for the next 15 years (or just give them all a nice 10-20 in a not actually nice prison)
next up for the Full Roman Treatment the guys that make Naloxone/Narcan
The drug itself is generic. The mechanism in a modern EpiPen is still covered by patents, I say modern because the design gets frequent updates with all new patents.
There are other autoinjectors for Epinephrine. Some of them are not very good, which is a shame because the old 1997 design from Meridian Medical would be to old to still have patents yet it is a satisfactory design.
One problem with these different autoinjectors is that doctors usually teach a patient how to use a particular design, and drug reps usually introduce doctors to the injection method. It's not hard to learn to use one, but every design is a little bit different. And if you're not familiar with a particular design it can result in accidental injection. Some old designs had two doses, but these end up being kind of complicated to use safely, even if they are half the cost of a 2-pack.
If it's not innovative why is it patented?
putting the 'B' in LGBTQ+
Drug Dealers steal money, film at 11.
EpiPen comes from Epinephrine. It's called that because it's a pen-like device that injects Epinephrine. Another more commonly known name for Epinephrine is Adrenaline. It's a pen-like device that injects Adrenaline.
Adrenaline/Epinephrine is as "generic" as it gets. You can even extract it from animals. It costs next to nothing. When OP writes "a brand-name drug such as the EpiPen", that is grossly misleading. The "drug" inside is a naturally occuring hormone, and the medical device used to inject it isn't a drug.
Just because they have patented this particular method of drug delivery doesn't mean that others cannot be used. You could inject the drug using a syringe. You could make another type of auto-injector.
Making any kind of judgement about this is hard. From the wording itself, Mylan seems absolutely in the right - Adrenaline is a non-innovator multiple source drug.
It's possible that there are particular rules that extend the term "drug" to a one of several methods of delivering that drug, so that e.g. a syringe could be classified as a drug. But that would be speculation.
This is just more of the mindless agitation, trying to make people angry, and exploiting that anger.
Epinephrine is old and is or should be generic. The auto injector is a drug delivery system, and should I think be treated separately.
It could deliver any injectable drug no?
That there are no effective competitors to Mylans EpiPen reeks of impropriety.
This is capitalism at its finest. Every capitalist wants government mandates and protection for its monopoly. More money that way. When poor people get money from the government it is socialism, and when big business gets money from the government it is capitalism?
I would suggest an investigation of Health insurance Companies and Big Pharma to see how interlocking the Boards of the companies are. Also source drugs from outside the United States. If you recall they passed laws to make you a criminal for going to Canada for your prescriptions. Call them all in for Congressional hearings and threaten to re-instate anti-trust laws on all involved Bust up the biggest of the bunch. Set down and tell the AMA that there will be more admissions allowed to medical school and there would be government incentives for more medical schools at Public universities. Make it so there are as many Doctors in this country as Subway sandwich shops. To make it more competitive for the consumer. It's sad that free market economies have gotten down to precisely controlled conspiracies to fleece the public. Physician heal thyself. Of course you will have to Jail the members of the house and senate for corruption on failing to investigate the corruption.
With the patent system as it is, where genetic codes and proteins can be patented, and where protection for drug profits is long and deep, there are situations like this that come up that allow unscrupulous companies to hike drug costs ridiculously like these clowns at Mylan.
Yes, many drug research efforts don't pan out. But Epinephrine has been out for a long time. Is anyone seriously going to try to tell me that $50 in 2007 became $304 in 2017? Even given the bogusly low inflation rates that are officially reported, that's insane.
This is profiteering. If the company didn't need to profiteer in 2007, why do they in 2017? No good reason methinks.
How about the definition of sole source is 'no equivalent product available at present'?
And how about you cap the rates at which drug costs can increase unless the providers can show material evidence that their costs have escalated so much?
I don't have $608 to shell out (US) for something I have to replace every 1-2 years. I'm carrying an old epi-pen that's probably not as efficacious now, but it's likely still better than no pen. I just can't afford the money to get a new one (let alone two, since protocol says you hit yourself with the first and about 30 minutes later the second if you haven't reached emergency medical care).
This should be a true generic. There should be equipment whose patents have an earlier mandatory expiry because they exist in the space called 'in the interest of public health'. I'm not suggesting these guys shouldn't have got their money back, but seems to me they are well beyond that point now.
On the other hand, this is exactly why the government or NGOs should be investing in some sorts of medical research in the public interest and making the product patents entirely open and available.
Epinephrine isn't patented. Its the injector. This seems like the kind of thing a Gates Foundation or even the Government could underwrite the development of (and may have already for Atropine and the like in prior days, if we call those syrettes an early version). Make the injector patent available and then it truly is generic because epinephrine is not patented.
The reality is that big Pharma has great lobbyists, political connections, and lawyers and the whole US patent system around biomedical issues defies any sort of common sense or rational thinking.
I hear rumours of alternatives, but I'm not sure they are available beyond the US borders. The Epipen fiasco and the price rise has hit many of us living in other countries too, but I'm not sure any alternatives exist where I live. I am going to look into that now though.
Patents should help protect innovation, but not form monopolies artificially (well, that may be other legislation that does that but that also needs looked at), should not have extensive duration, and should have clauses surrounding medical equipment that if the equipment price rises too quickly or if the provider becomes sole source, that the patent becomes licenseable by other companies for a very modest fee. At some point, the public interest has merit at least as great as profits for corporations.
-- Mal: "Well they tell you: never hit a man with a closed fist. But it is, on occasion, hilarious."
This is why other countries enforce a single buyer system. The US government can't give corporations entitlements (rubber-stamped patent, paperwork advantage), then complain when the corporation maximizes profits. The government can't do anything if other pharma corporations don't want to compete, or the paperwork advantage prevents fair competition.
The government can stop subsidizing the epi-pen and recommend alternative products (hopefully without mentioning brand names), after all, they're not making consumers buy the recommended products. Or, since Obama wants patent reform, the government can contest the epi-pen patent which will allow other pharma corporations to make injector pens without fear of a lawsuit.
Now, that's exactly what I mean. With such political ties it's quite possible the FDA has been influenced also in maintaining a monopoly for Mylan.
"Trump!!", the new Godwin.
...and Mylan's taking the opportunity to capitalize on it.
And might have a CEO incarcerated for being just a tad too greedy.
"Trump!!", the new Godwin.
And you Americans respond to this, not with "This company is a bunch of unethical shitbags by raising the price of this livesaving medicine from $50 to $600, they should be imprisoned and the entire fucking system replaced with something better" but "Oh hey, it would have been ok if they'd given us a cut of the profit"
Why would Mylan agree to such terms for Medicaid? If Mylan just says "This is the price, buy it, don't buy it, develop an alternative, approve an alternative -- we don't care. If you don't commit to buying some number of units, we may not be able to meet your demands so you will have to buy them at inflated prices on the secondary market. Let us know by next Tuesday.", then Medicaid needs to pay for it or declare that it's not a covered medication for those on Medicaid.
Presumably Medicaid could institute a training program to teach injection without "autoinjectors" to everyone (patients, caregivers, responders in schools etc) who might need to use the "low-tech" solution. However, that would probably be much more expensive than paying list price.
It seems that pharma, if they played their cards right, would discover that the government actually has little negotiating power since Medicare (especially) and Medicaid patients will go to their Congresscritters to complain if a drug isn't covered and their representatives would, for political rather than strictly medical or economic reasons, insist that the drug be available regardless of cost. For an example of how political forces result in bizarre outcomes, consider that Medicare covers late stage renal failure for those under 65 for some reason, but almost no other chronic and expensive conditions are covered for those under 65.
Why is there an "insightful" mod and why isn't it "-1"? If I wanted insight, I wouldn't be reading
The UK NHS net prices for the 3 alternatives approved in the UK are:
Emerald (iMed) £26.94
EpiPen (Meda) £26.45
Jext (ALK-Abelló) £23.99
(aproximately US $30 to $35)
https://www.evidence.nhs.uk/formulary/bnf/current/3-respiratory-system/34-antihistamines-hyposensitisation-and-allergic-emergencies/343-allergic-emergencies/anaphylaxis/adrenalineepinephrine
Meanwhile, in the civilised world, our govenments negotiate huge bulk discounts, and prescrition drugs are subsidised to a fixed maximum.
The best part, we spend less per capita than the US on healthcare. Go figure.
It's a generic.
http://adrenaclick.com/
(And there are others in Europe.)
Mylan marketed EpiPens as if they were a big time non-generic drug, getting many health care providers (including many Medicare offices) to agree that EpiPen was the preferred (or mandated) brand for their patients. This is all marketing and contractual monopolies, not patent protection.
This whole debacle exposes that our health care system cannot properly evaluate competition and cost. When you tell someone "you're the only one I'm going to buy this from, and I'm going to make it really, really hard for anyone else to get even a part of this contract," you're going to get ripped off. It is this severe lack of business sense on the part of our health care administrators (public and private) that allow BS like this to happen. Medicare offices should be working to ensure that they contract with at least two sources for any off-patent drug or device.
The CEO of Mylan is daughter of a senator, and that could explain a lot.
Don't mince words Bones, tell me what you really think (cit.)
The CEO of Mylan is daughter of a senator, that explains could she could buy legislation that favored her company and made schools captive of Epipen products.
Institutionalised bribery at its american finest.
Every prescription I've ever gotten has had a thing on it that says that it can be filled with generic equivalents. And responsible, ethical doctors would never write a name brand on a prescription.
> The FDA wouldn't have anything to do with the recall, and a request for more information isn't really a particularly effective use of corrupt power.
And if you believe that, I've got the Eiffel tower to sell you for scrap. Just wire me the money to this address in Nigeria.
> And responsible, ethical doctors would never write a name brand on a prescription.
There can often be subtle differences, including quality, packaging, and filler components, that make one version more effective for a specific patient. So yes, sometimes doctors do name a specific version of a medication for good medical reasons. "Generic" does not mean identical.
Sometimes that may not be the best option for the patient however:
"Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias" http://www.ajconline.org/article/S0002-9149(00)00715-3/abstract
Epinephrine is not a "brand name drug". It's a hormone. Humans produce it. Animals produce it. It's been used medically for scores of years. It's as much of a "brand name" as insulin. Epi-Pen is the INJECTOR, not the drug itself. Now if you're going to tell me that no one else should be allowed to produce an auto-injector - ANY auto injector, because someone has a patent on one DESIGN, then America deserves this. Insulin syringe, 1:1000 epinephrine ampule 1cc, inject .5 cc subcutaneous or im and voila, the $4 "Epi-Pen".
Seven puppies were harmed during the making of this post.
It makes me sad to read all these cries for supposedly needed increases in regulation and how supposedly the Mylan situation shows that "free market" failed. No, it shows entirely the opposite. The whole reason the situation is the way it is is BECAUSE OF vast amounts of regulations. The patent system needs a total reform and there needs to be a very through audit into the practices of the FDA.
Just because there is no competition does not give excuse to defraud government. It's government stupidity that led to having a patent system this stifling to begin with, so obviously firm regulation and price control is necessary to deal with it.
" The point is, ladies and gentleman, that greed -- for lack of a better word -- is good.
Greed is right.
Greed works.
Greed clarifies, cuts through, and captures the essence of the evolutionary spirit.
Greed, in all of its forms -- greed for life, for money, for love, knowledge -- has marked the upward surge of mankind." (Gordon Gekko)
It's the fucktard known as bitztream, the autism-hating Slashdot troll!
The USA doesn't want to be civilized. We want to be great again, not civilized! The USA is going to build a wall, and make the civilized world pay for it! Trump 2016! He'll outlaw belly fat!
Ask your doctor for a generic? Sounds like work to me. It's much easier to pass a bunch of complicated regulations to force things to be cheaper so I don't have to do anything.
My Other Computer Is A Data General Nova III.
This isn't tech, it's not even YRO. It's politics over an off-patent chemical in a fancy plastic case with a stabby bit inside. Why is this on the front page, or even at the site at all?
This is a small sacrifice I'm willing to make. Hell, the candidate I'm voting for should be in jail, but she's not.
I don't see why people can't follow Dr. Dunbal's suggestion and learn how to use plain old syringes and an ampule of epinephrine. If I had one of these allergies, I'd learn how to do that. There's also the "epipencil." Alternatives exist.
The alternative, legitimizing the alt-right, really is that much worse.
We're still on course for the 2018 riots.
Just a few more years now until it all goes down in flames. But whatever happens, never abandon your humanity as the alt-right have. Compassion is a human emotion. It's one of many things that separates us from animals. As long as most people don't abandon their humanity, we can make it through. Things will get better. The walk to the gas station will be for your own good.
(Compassion is not the same as coddling.)
One problem is that the only word that people know how to use to describe Epipen-like injectors is, er, well "Epipen". Arguably the trademark word "Epipen" has become part of the standard English language like "Escalator", "Aspirin", "Jello" and the like. The trademark puts any competitor (present or future) at a huge disadvantage because they can't use the word Epipen, and the public doesn't know how to ask for anything else.
Another big problem in this space is that the time and money to get FDA and insurance reimbursement approval for generic (off-patent) products huge. This creates a large barrier to entry and helps keep the cost of health products crazy high.
Private company hikes prices by a lot, and scams the Guvmint.
Which somehow becomes an indictment of "socialized" medicine, and showing how the private market is superior and honest and trustworthy.
The shepherds did so well protecting the flock that the sheep no longer believed that wolves existed.
You can cheat the citizens, but you can never cheat Uncle Sam. Doesn't matter if we get screwed, only if the government sees a loss. Then suddenly it becomes a priority.
Weaselmancer
rediculous.
No, every capitalist wants a fair, open market (lassez-faire capitalists just think it happens without regulation). Government collision with business is either cronyism or fascism.
The FDA should at least be required to "show its work" in any rejections. Exactly why did Teva, which is one of the largest generics manufacturers in the world market, have its product rejected?
Then I would go farther and allow doctors and patients to make up their own minds about FDA-tested products, whether accepted or rejected. If a rejection was for some paperwork problem or a situation that applies only to a limited class of patients that does not include yourself, why not prescribe it anyway?
Adrenaclick, the big problem is epipen has become a generic like keenex but pharmacists have to go through hoops to replace it with a competitor.
No sir I dont like it.
....shake their heads at your whining.
....what's the big fucking deal then? Does the brand name label mean do much to you? Snobbish much?
The FDA does give a full report with their rejections, but I don't have a copy of this particular one readily available. My best source is that I used to work in the pharmaceutical industry, in the process for getting new drugs to market. In short, it's a mess even without any accusations of corruption.
I don't think I've ever heard of a modern drug getting approved on its first try (though that's also not where my experience focused). The most common reasons for retesting were things like imprecise side effect rates (two patients in the trial had a headache, so the whole trial needs to be 10x larger to reduce the margin of error) or a lack of documentation (you computed this incidence rate using the standard formula, but exactly what is that formula?).
The problem with a user-centric approach is that you start having public health decisions being made by people with no understanding of what's actually happening. Physicians usually focus on diagnosis and treatment monitoring, not understanding the biochemical interactions of the drugs they recommend. Pharmacists understand the chemistry and interactions, but patient risk analysis and diagnosis is outside of their job. Add a layer of traditional American marketing on top of that, and you have a perfect market for snake-oil salesmen to promote insufficiently-tested medicines to doctors and patients who have no way of knowing how unsafe the medicine is. Doctors can be conned, too.
You do not have a moral or legal right to do absolutely anything you want.
Every single Mylan employee who needs an Epipen should be found, their allergy triggered and left to die without an Epi.
If you can't find the FDA rejection report in todays age if internet, pdf's, and so on, ... then it seems quite exceptional to claim that the report is "available."
"Available" isn't supposed to mean it is in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying 'Beware of the Leopard.'"
"His name was James Damore."
This is capitalism at its finest. Every capitalist wants government mandates and protection for its monopoly.
Sure, blame the people that want things instead of the people that authorize those things.
"His name was James Damore."
If they want to go with the "we arent the only ones making this" so they dont have to give so much back to the government, then the government should waive their patent protection and allow other companies to make the stuff. Problem solved, people would then get the things at a reasonable price and the company wouldnt be lying.
"The problem with a user-centric approach is that you start having public health decisions being made by people with no understanding of what's actually happening."
I would hope to hell that my doctors have an understanding of what's actually happening! That's what med school and years of experience are for.
Making FDA decisions advisory, rather than mandatory would preserve its essential testing function while taking corruption of the sort that is strongly suspected in the Epi-Pen case out of the equation.
And on the FDA site, I see databases of approvals and lists of rejections, but no details on rejections. We should have as much detail on rejections as we have for approvals. The reason we're not seeing that information is that the federosaurus is terrified of the possibility of us making up our own minds - about anything.
That is the problem for these single source drugs where someone can literally die if they don't have the drug. Do you fork over the $600 for the EpiPen that could save the life of a loved one in the case of anaphylactic shock, or not? Of course you do.
The reality is that FDA regulators need to fix the price and peg the rate of price increase to inflation for products or drugs that get transferred or bought by another company. Mylan did not invent the EpiPen, and jacking the price of a lifesaving product like that from $50 to $600 is criminal profiteering, the same kind that lands people in jail during natural disasters. Mylan executives should be prosecuted under the same statute. They have no justification for the price increase, they were presumably profitable at $50. The design of the EpiPen did not change or become more expensive to produce in the last 10 years. Perhaps the best punishment would be to invalidate all of the patents surrounding the EpiPen based on the fact that Mylan has abused those patents and already extracted the maximum profit that society should tolerate, seeing that they did not even invent the damn things in the first place.
When a drug first comes to market, there are very large costs that have to be recovered, and it is acceptable for drugs to be expensive. However, there is just no excuse for buying a 50 year old device from another company and then jacking up the price 5X just to make as much money as possible over threat of someone's life.
If you disagree, please post your argument. (-1, Overrated) isn't your personal censorship tool for views you don't like
Nobody cares You must pay, its the law! And they use your money to make laws to make you pay even more money !!!
Epinephrine is old and is or should be generic. The auto injector is a drug delivery system, and should I think be treated separately.
It could deliver any injectable drug no?
That there are no effective competitors to Mylans EpiPen reeks of impropriety.
This is DEMOCRAT CRONY capitalism at its finest. Every DEMOCRAT wants government mandates and protection for its monopoly. More money that way. When poor people get money from the government it is socialism, and when DEMOCRATS gets money from the government it is capitalism?
FTFY. The CEO of Mylan Heather Bresch is the daughter of Democrat Govenor/Senator Joe Manchin. We already know that she lied about having an EMBA from WVU and used her fathers influence to get a fraudulent, backdated degree. After a big SNAFU over it, a number of WVU top executives had to step down. She is politically connected and likely behind the failures of the other injectors. The EpiPen was invented in 1977. The technology is ancient and simple and Mylan doesn't even make it, they buy it from Pfizer for $34.50 each...
Capitalists want the government to ensure a fair and even playing field, not put their finger on the scale for one side. Corrupt businesses/CEOs may want unfair advantages, but they are not capitalists, they are criminals.
If you disagree, please post your argument. (-1, Overrated) isn't your personal censorship tool for views you don't like
Well, when my doctor wanted me to carry something like that around, he filled a couple of disposable syringes with adrenaline, put them in a plastic case, and said "Use them if you need to. They should be good for a year if you keep them sealed and don't get them too hot." He also wrote out a prescription for Epipen if I felt more comfortable with that approach. As I happens I never had to use them.
I think we've pushed this "anyone can grow up to be president" thing too far.
It's not multiple source unless there are multiple sources. I'd go further and say it's not multiple source unless there are multiple sources that are covered by the same prescription/insurance plan.
If they want to not be considered single source, they need to be taking steps to ensure that there is actual competition.
I think we've pushed this "anyone can grow up to be president" thing too far.
This is the literal opposite of capitalism. This is corporatism. Capitalism involves heavy competition, which drives down prices. Skipped too much school?
They should simply rescind the patent as punishment for stiffing the government.
Don't just stand there, get that other dog!
It may well have been a generic with multiple sources back in 2007. As I understand it, Mylan made some design tweaks, patented them, and then claimed that anyone making a generic version would be infringing on their new patents.
That's true. But, -according to the doctors I talk to- in most situations (unlike how it works with pretty much any other drug) a pharmacist may not substitute an Adrenaclick when presented with a prescription for an EpiPen. In order to be able to sell an Adrenaclick-brand autoinjector, the prescription needs to be written for either an "adrenaline auto-injector" or for an Adrenaclick.
Rule-makers' stated reasoning is something along the lines of "We don't want people who've trained on one auto-injector to get confused if they're presented with another!". But from what I hear, the two are functionally identical.
Was that what you said when mortgages were handed out like candy?
Because Mylan took a drug someone else invented and an injector someone else invented, and patented using this injector to administer this drug.
No different than most other patents out there.
These Drug Companies are only in it for the money. Please shut them down or force them to provide reasonable pricing and provide CURES not a "drug" that makes you feel better that you have to use for your entire life making the drug companies trillions of dollars. I understand the EpiPen is a value and needed product, but come on $608 for a 2 pack that is outrageous!!
Perhaps I should clarify that statement by saying that the reports are available, but I don't care enough about this particular case to go find this particular report, just to satisfy what I see as a mob that complains about things they don't bother to understand.
You do not have a moral or legal right to do absolutely anything you want.
Your Dr is awesome. You should've used one before a workout to bring out the tiger and show 'em what you can do!
I would hope to hell that my doctors have an understanding of what's actually happening! That's what med school and years of experience are for.
I have some very bad news for you, then...
Since this is Slashdot, a car analogy may be best. If you take your precious high-performance sports car to a mechanic to find out why it's not getting the power that it should, he can look at the engine, perform tests and measurements, and tell you that your engine needs a fuel with a higher octane rating. He may not know precisely what an octane rating means chemically, or what chemical processes are taking place during combustion that affect the engine's performance, but he knows the cause of and solution for the symptoms presented.
Similarly, a physician does not usually need to know all of the biological processes that a particular drug affects. Knowledge of common interactions and side effects is necessary, but not the rare effects or anything easily treatable. Basically, if the treatment isn't going to be worse than the disease, they don't need to waste their time or memory thinking about the minimal chance of a mild adverse reaction.
This is not to disparage the medical professionals in any way, but only to clarify what the scope of their job requires. A programmer doesn't need to understand the particle physics that make semiconductors work, a carpenter doesn't need to know how to grow the wood he uses, and a doctor doesn't need to know every side effect for the 10,000 FDA-approved drugs he can prescribe today. Such knowledge just isn't necessary to be an expert in the field.
Making FDA decisions advisory, rather than mandatory would preserve its essential testing function...
...but completely undermine the incentive to actually perform that testing thoroughly and ethically. After an effective marketing campaign, there's no difference between "submitted for FDA approval" and "approved by the FDA", even if the former really means the manufacturer submitted only a brief description of the drug and it was rejected immediately. If, even without approval, the drug can still be marketed and promoted and prescribed, then it's more cost-effective for the manufacturer to run damage-control PR spin after a bad reaction than to actually ensure their products are safe in the first place.
And on the FDA site, I see databases of approvals and lists of rejections, but no details on rejections. We should have as much detail on rejections as we have for approvals. The reason we're not seeing that information is that...
...such information is rapidly out of date, and doesn't matter because doctors can't prescribe those drugs, anyway. The only purpose it serves is to terrorize the public with bad news about a drug that might eventually be considered safe, which in turn just makes it more difficult to convince patients that they should follow their prescribed treatment.
If you want to follow what's going on, I'd recommend some industry publications, which usually strike a nice balance between the technical details and the ultimate impact.
You do not have a moral or legal right to do absolutely anything you want.
A specialist MD develops an instinct for gleaning needed information from test data summarized as it has to be for the kind of testing the FDA organizes. On occasion he might make use of a side effect that might be useful for some small subset of patients, which may in time mature into an "off-label usage" that becomes generally known in medicine.
Ability to prescribe any tested product, whether or not approved, would help push innovation in the long run. Some states already have "right to try" legislation allowing terminal patients to be prescribed any compound which has passed Phase I toxicity testing. Bootlickers hate Right To Try, but all I'm proposing is an extension of the increasingly popular concept to any informed patient.
So long as FDA testing proves to be a good assurance of quality product, its reputation as a gold standard will retain value, so that products labeled "FDA Approved" will be worth, on the average, more than products that doctors grab from the middle of the testing process under my scheme. If they do not, then our testing protocols need a lot more work.
If we keep on giving the FDA veto power over what products can come to market, then your brand of socialized price control is inevitable. How will patients feel about the rationing that always goes with such schemes? I would rather go in the opposite direction instead, stripping the FDA of its power to keep products off the market so that fully informed doctors and patients can decide for themselves how much risk to take.
Sanofi's Auvi-Q injector was pulled because of 26 specific instances of dosage error out of all the patients that used the device. Since no injector can deliver more epinephrine than it contains, might you be willing to assume a small degree of dosage uniformity risk as the cost of a competitive market?
Was that what you said when mortgages were handed out like candy?
You mean those mortgages guaranteed by Fanny aka Federal Government?
"His name was James Damore."
The head of the company is the daughter of a high-powered Democrat Senator. The head of the USA Federal Government is a high-powered Democrat President. That's two reason why a Democrat-led company would receive preferential treatment. A few years back, the news media called this "Crony Capitalism". Andy Jackson did this and history books call it the "Spoils System". To the winner goes the spoils. To the powerful goes the ability to beat the powerless. I'm surprised the Feds decided to do anything about this situation.
There was the generic adrenepak and another whose name escapes me at the moment (it was the subject of an FDA recall), so it is *not* a single-source drug so the higher Medicaid rebate amount is not called for. It seems the real problem isn't the price of the epipen, it's that doctors are writing name-brand epipen prescriptions, locking patients into the higher-priced product. In most states pharmacists can not supply generic equivalents when provided with a name brand-specific prescription.
A specialist MD develops an instinct...
...or so you hope. Unfortunately, I've worked with enough doctors who just don't care that I won't accept that as a blanket statement for the entire profession.
...all I'm proposing is an extension of the increasingly popular concept to any informed patient.
But now you have to define what an "informed patient" is. I've also worked with enough patients who spent too much time with WebMD to accept that people can be well-informed just by reading a few articles on what they think applies to them.
...products labeled "FDA Approved" will be worth, on the average, more...
As long as that label is honest and respected, sure... but there's nothing to stop a fly-by-night operation from selling a drug with a not-quite-approval label and unscrupulously allowing doctors and patients to interpret the labeling (and marketing) as though it were actually approved. That, in turn, dilutes the FDA approval process, because if you can sell your drug enough to become standard without the hassle of approval, why bother? Do you actively check for a UL label on all of your electronics?
I hate to appeal to emotion, but the consequence here is literally peoples' lives. If it costs more to go through the FDA testing process, but saves the lives of people who would have been misinformed, is it worth the price? Conversely, do people deserve to die because they misunderstood the risks?
You do not have a moral or legal right to do absolutely anything you want.
I didn't want to waste bandwidth by repeating my original proposal on FDA reform, but if you insist: the FDA would lose all powers to keep compounds and devices off the market. In return, every product submitted for FDA would bear a label indicating FDA Approved, FDA Rejected, or FDA In Testing. Each label would bear a QR code leading to online detail about the status of the product, including detail about rejection or the current in-test status. It would continue to be an offense to misrepresent the status of a product, and absence of a label would indicate a product not submitted to the FDA at all.
I would expect that malpractice liability being what it is, most MDs and insurance carriers would insist on prescribing of FDA Approved products in ordinary cases. But if prescriptions can be written for compounds approved by the perfectly good testing authorities in Europe and Asia - if you really are in the business you must be aware of my wife's hometown, Basel, being the center of the world in advanced pharma development - then we will see a lot less gratuitous foot-dragging by the FDA.
Were my reform would really prove its worth would be in situations of obvious corruption like the Epi-Pen trainwreck, the Colcrys debacle and the Daraprim dumpster fire. In cases like this allowing doctors to prescribe from the world market is not theoretical libertarian posturing, but a moral imperative.
The consequence certainly is peoples' lives. How many lives are lost due to not being able to afford lifesaving medications and healthcare?
Yes it's an anecdote! Were you expecting original research in a Slashdot comment?
It's bitztream, Slashdot's answer to Trump!
You must be unaware of how the process works. The FDA had sent Teva a Complete Response Letter (CRL). Teva is fully aware of why they were rejected. These are confidential communications, Teva is free to share what they wish with the public.
Exactly why did Teva, which is one of the largest generics manufacturers in the world market, have its product rejected?
You'll have to ask Teva about that. It's confidential, proprietary information that's between FDA and Teva.
Nothing will happen because the CEO's Daddy is a big wig Democrat with enough Clinton connections to stop any of this from getting to the criminal stage. It'll be business as usual for the most corrupt political party this side of Stalin's Bolsheviks.