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posted by martyb on Thursday October 06 2016, @11:44AM   Printer-friendly
from the shoulda-got-the-EpiPencils dept.

If you're going to overcharge the U.S. government, you don't want to get caught:

Mylan NV for years overcharged the U.S. Medicaid health program to buy its EpiPen shot, the government said Wednesday, despite being told that it needed to give bigger discounts under the law. From 2011 to 2015, the joint state-federal program for the poor spent about $797 million on EpiPens, the Centers for Medicare and Medicaid Services, or CMS, said in a letter Wednesday. That included rebates of about 13 percent, but the U.S. should have been getting a larger discount of at least 23.1 percent.

While the agency didn't say exactly how much Mylan had overcharged, the amount could be substantial. Under law, companies are required to give [Medicaid] back any price increases they take on brand drugs above the rate of inflation, in addition to the 23.1 percent discount. Mylan, after acquiring the drug in 2007, has raised the price of EpiPen by about sixfold, to over $600 for a package of two. The government has in the past "expressly told Mylan that the product is incorrectly classified," CMS said in the letter, which came in response to an inquiry by Congress. "This incorrect classification has financial consequences for the amount that federal and state governments spend because it reduces the amount of quarterly rebates Mylan owes for EpiPen."

Previously:
EpiPen's Price Increased 400% since 2008
AllergyStop: $50 EpiPen is Production-Ready but...


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  • (Score: 2) by wisnoskij on Thursday October 06 2016, @12:29PM

    by wisnoskij (5149) <jonathonwisnoskiNO@SPAMgmail.com> on Thursday October 06 2016, @12:29PM (#411062)

    From my understanding this entire thing comes down to if it is a proprietary drug. If they are the only source then they get paid X for it, if they are not they are paid Y for it. Where X >Y, and X is what they were getting paid. Now the drug absolutely is not exclusive, but the EpiPen is a combination of the opensource drug and the delivery method, which is proprietary and sold only through them.

    • (Score: 2, Informative) by Anonymous Coward on Thursday October 06 2016, @01:02PM

      by Anonymous Coward on Thursday October 06 2016, @01:02PM (#411071)

      If, as you say, it comes down to legal arguments about sole vs multi sources, I think that would be a shame.

      Seems to me that a 6x price hike of a mature product, over 9 years, combined with exorbitant executive pay (at expense of stock holders) should be the topics of interest? Or in simple words, follow the money.

      • (Score: 3, Insightful) by bob_super on Thursday October 06 2016, @04:26PM

        by bob_super (1357) on Thursday October 06 2016, @04:26PM (#411141)

        As long as you follow the exact letter of the law, it's not illegal to be a greedy heartless asshole.
        But if you attract too much attention by being a greedy heartless asshole, you'd better make sure that you did indeed follow every rule to the letter.
        Or have a Senator for a dad. Or provided the right amount of campaign contributions.

        • (Score: 3, Interesting) by Nerdfest on Thursday October 06 2016, @06:47PM

          by Nerdfest (80) on Thursday October 06 2016, @06:47PM (#411202)

          The punishment for this kind of douche-baggery should be immediate transfer of the patent to the public domain.

    • (Score: 1) by Francis on Thursday October 06 2016, @01:53PM

      by Francis (5544) on Thursday October 06 2016, @01:53PM (#411089)

      This probably wouldn't have been an issue if the medicare was allowed to negotiate over medication prices or contract with pharmaceutical companies to provide medications that were out of patent protection, but only being provided by a single source that wasn't providing reasonable prices.

      You've got to love those free market conservatives that literally wouldn't recognize a free market if it jump up and bit them on the ass.

      • (Score: 2) by tangomargarine on Thursday October 06 2016, @02:23PM

        by tangomargarine (667) on Thursday October 06 2016, @02:23PM (#411102)

        Not being an economist, I'm not sure whether to observe that

        A) the free market inevitably converges on monopolies, or
        B) our government just can't keep its hands out of the market by giving specific companies advantages which help them become monopolies.

        Into which patents and various other things come into play.

        P.S: For anyone saying that the U.S. isn't a free market economy, show me a country that is or STFU.

        --
        "Is that really true?" "I just spent the last hour telling you to think for yourself! Didn't you hear anything I said?"
        • (Score: 1) by Francis on Thursday October 06 2016, @08:31PM

          by Francis (5544) on Thursday October 06 2016, @08:31PM (#411232)

          According to Adam Smith the original source for the notion of the free market, a free market will always converge on a single source monopoly covering all legal economic activity if the government doesn't step in and regulate the activity.

          As for the US being a free market economy, we absolutely aren't and the lack of other countries with free market economies is not a reasonable argument to make.

    • (Score: 3, Interesting) by tangomargarine on Thursday October 06 2016, @02:21PM

      by tangomargarine (667) on Thursday October 06 2016, @02:21PM (#411100)

      I think it can be explained much more simply: Greed.

      I guess the government getting them cheaper is a good thing, but why are they so damn expensive in the first place? Yeah yeah, make back the cost of research. The proprietary part is an *injector* for crying out loud, not a genetically-engineered cloned superchimp or something. How long ago did they first release them? Talk about your payback periods. . . . Presumably they'd say that they still need that income to research all their other massively overpriced new drugs.

      Here's a crazy idea: How about a reasonable price (ergo a reasonable profit margin, not gouging people for all they're worth) that's a flat rate for everyone?

      --
      "Is that really true?" "I just spent the last hour telling you to think for yourself! Didn't you hear anything I said?"
      • (Score: 5, Funny) by GreatAuntAnesthesia on Thursday October 06 2016, @02:40PM

        by GreatAuntAnesthesia (3275) on Thursday October 06 2016, @02:40PM (#411107) Journal

        The proprietary part is an *injector* for crying out loud, not a genetically-engineered cloned superchimp or something.

        - OK Mr Reynolds, so you're here for your flu jab, is that right?
        - Yes Doctor.
        - Good. Now Mr Reynolds, you may remember that when you booked this appointment, you ticked the box to take part in a trial for an experimental new drug delivery method called GECS-C.
        - What's that banging noise? I think it's coming from next door.
        - Never mind that, Mr Reynolds. As I say, we have this experimental new drug delivery method, which...
        - It sounds like someone is throwing furniture at the ceiling. And what is that ungodly screeching sound?
        - Yes yes, we'll come to that soon enough. The point is, you may get your vaccination administered via the experimental method, or you may be in the control group which will have it administered by traditional means. But we won't be telling you which group you are in until the trial is concluded. Do you understand?
        - Um, yes. The noise is getting... oh, what's that?
        - I just need to smear this onto your face, Mr Reynolds.
        - Oh. Is that the new drug delivery thingy?
        - No no, Mr Reynolds, this is just mashed banana.
        - Mashed..?
        - It will all become clear soon enough. Now I'm going to leave the room and lock the door, and shortly afterwards then that door over there will open. When that happens Mr Reynolds, I advise you to remain completely calm, and make no sudden moves...

      • (Score: 2) by martyb on Thursday October 06 2016, @07:44PM

        by martyb (76) Subscriber Badge on Thursday October 06 2016, @07:44PM (#411222) Journal

        I think it can be explained much more simply: Greed.

        Agreed.

        I guess the government getting them cheaper is a good thing, but why are they so damn expensive in the first place? Yeah yeah, make back the cost of research. The proprietary part is an *injector* for crying out loud, not a genetically-engineered cloned superchimp or something. How long ago did they first release them? Talk about your payback periods. . . . Presumably they'd say that they still need that income to research all their other massively overpriced new drugs.

        From what I can tell, their research costs for the EpiPen have long since been paid for; from CNBC [cnbc.com]:

        [The] gap between cost and price have delivered some very nice revenue for Mylan, where EpiPen is a leading product. The company reported $9.45 billion in revenue for 2015 — up from $7.7 billion the year before — and $1.46 billion in income. A reported $1 billion in revenue comes from EpiPen, up from the $200 million in revenue at the time Mylan first acquired the devices.

        While Mylan has aggressively sought to expand the market for EpiPens by getting them placed in schools and trying to get them mandated for all airlines flying in the United States, the company didn't have to spend a nickel actually creating the product.

        The EpiPen was acquired by Mylan in 2007, along with other products from Merck.

        The device itself had been around decades before that. EpiPens were invented at a Maryland company called Survival Technology in the 1970s by engineers who included a man named Sheldon Kaplan.

        Originally called the ComboPen, the devices were bought by the U.S. Department of Defense for use in delivering medicine that would counteract the effects of nerve agents. Kaplan later tweaked the ComboPen to deliver epinephrine to counter the effects of anaphylaxis.

        See also Wikipedia's entry on the EpiPen [wikipedia.org] which notes:

        Autoinjectors were originally developed for the rapid administration of nerve gas antidotes in kits like the Mark I NAAK. The first modern epinephrine autoinjector, the EpiPen, was invented in the mid-1970s at Survival Technology in Bethesda, Maryland by Sheldon Kaplan[8][9] and was first approved for marketing by the FDA in 1987.[10]

        In 1996, Survival Technology merged with a company called Brunswick Biomedical and the new company was called Meridian Medical Technologies Inc..[11] In 1997, Dey, a subsidiary of Merck KGaA, acquired the exclusive right to market and distribute the EpiPen.[12][13] In 1998 there was a recall of one million EpiPens, the second such recall in a year.[14]

        In 2001 Meridian and Dey introduced a two-pack version of the EpiPen; at that time the device had $23.9 million in annual sales and accounted for 75% of the market in the United States.[15] In 2002 King Pharmaceuticals acquired Meridian for $247.8 million in cash;[16] the deal was completed in January 2003.[17] (King was later acquired by Pfizer in 2010 for $3.6 billion in cash.[18]) Kaplan continued to improve his designs over the years, filing for example US Patent 6,767,336 in 2003.[19]

        [...] In 2007, Mylan acquired the right to market the EpiPen from Merck KGaA as part of a larger transaction.[26] At that time annual sales were around $200 million[27] and the EpiPen had about 90% of the market.[28]

        --
        Wit is intellect, dancing.
    • (Score: 2) by Capt. Obvious on Thursday October 06 2016, @02:22PM

      by Capt. Obvious (6089) on Thursday October 06 2016, @02:22PM (#411101)

      You're right, the whole thing hinges on whether it's a proprietary drug. The letter goes into details as to why even though Wyden filled out the paperwork as though it was non-proprietary (generic) it actually should be classified as a proprietary drug. Their reasoning:

      EpiPen
      is
      approved
      under
      a
      New
      Drug
      Application
      (NDA)
      by
      the
      Food
      and
      Drug
      Administration
      (FDA)
      ,
      has
      patent
      protection,
      and
      has
      no
      FDA-approved
      therapeutic
      equivalents.

      You seem wrong on the complexity. This seems to be a cut and dried case, albeit one that should have been fixed long ago (the wonders of the legal system, somehow filling out the paperwork incorrectly for 20 years isn't something they can stop.).

      You're also wrong on the consequence. It seems generics get a rate of 13% off their average price. Proprietary drugs get 23.1% off the average price (or the best price, if that's better).

  • (Score: 5, Insightful) by Thexalon on Thursday October 06 2016, @01:45PM

    by Thexalon (636) Subscriber Badge on Thursday October 06 2016, @01:45PM (#411084)

    The health care industry is one of the few places where somebody can legally say "Give me all your money or you die." So rich sociopaths like Martin Shkreli and Heather Bresch, who have never been poor or even middle class and as best as I can tell see all non-rich people as Untermensch, are boosting the prices dramatically to basically rob people of as much of their income as they can get their grubby hands on.

    And this is why making health care a free market is crazy: Free markets depend on both the buyer and seller making an uncoerced choice, but in health care very few choices are uncoerced.

    --
    The only thing that stops a bad guy with a compiler is a good guy with a compiler.
    • (Score: 0) by Anonymous Coward on Thursday October 06 2016, @02:25PM

      by Anonymous Coward on Thursday October 06 2016, @02:25PM (#411103)

      Free markets don't have patents. The health care system is full of patents and regulatory capture, from the FDA limiting competition based on what they are willing to approve and what companies get their products approved (perhaps based on backdoor dealings) to patents. Free markets would result in lower prices.

      • (Score: 3, Insightful) by Capt. Obvious on Thursday October 06 2016, @02:27PM

        by Capt. Obvious (6089) on Thursday October 06 2016, @02:27PM (#411104)

        Please look up how trade secrets and contractual obligations operated pre-patent in England, and explain how that system is preferable.

        • (Score: 1) by khallow on Thursday October 06 2016, @05:07PM

          by khallow (3766) Subscriber Badge on Thursday October 06 2016, @05:07PM (#411155) Journal

          Please look up how trade secrets and contractual obligations operated pre-patent in England, and explain how that system is preferable.

          Perhaps you could tell us what the problems are supposed to be, rather than us waste our time on a unicorn hunt.

          • (Score: 3, Informative) by Capt. Obvious on Thursday October 06 2016, @06:55PM

            by Capt. Obvious (6089) on Thursday October 06 2016, @06:55PM (#411204)

            Well, an exhaustive list is difficult, and frankly would be just as long to read from me as from the type of research you're declining to do. But basically you had a lack of investment in things that could not be protected by trade secret, vicious anti-compete clauses in contracts, and a high likelihood innovations would disappear as the people who knew how to do them died out.

            The best paraphrase I've heard is, "patent law enforces open hardware, but in return guarantees exclusivity for a short period of time."

            • (Score: 0) by Anonymous Coward on Friday October 07 2016, @02:23AM

              by Anonymous Coward on Friday October 07 2016, @02:23AM (#411294)

              Basically you're just making things up, as is typical of IP proponents which are mostly composed of big business.

              and trade secrets already exist anyways. There is zero evidence that patents encourage the revelation of trade secrets, patents are useless in this regard.

          • (Score: 0) by Anonymous Coward on Friday October 07 2016, @01:27PM

            by Anonymous Coward on Friday October 07 2016, @01:27PM (#411472)

            For a real discussion on what patents do to innovation see

            https://www.techdirt.com/articles/20130503/17414322946/discussions-abolition-patents-uk-france-germany-netherlands-1869.shtml [techdirt.com]

            Also see the book Against Intellectual monopoly by Boldrin and Levine.

            As far as England was concerned England was doing fine until patents came along

            "This power was used to raise money for the Crown, and was widely abused, as the Crown granted patents in respect of all sorts of common goods (salt, for example). Consequently, the Court began to limit the circumstances in which they could be granted. After public outcry, James I of England was forced to revoke all existing monopolies and declare that they were only to be used for "projects of new invention"."

            https://en.wikipedia.org/wiki/History_of_patent_law [wikipedia.org]

            It was businesses, as usual, that pushed for these monopolies and they caused so much harm that it was public outcry that lead to their restriction. Their restriction was a good thing.

            Don't listen to the completely made up stories by patent supporters. IP has historically been pushed almost only by businesses that wish to limit competition (why should businesses decide laws) in their favor and the results have historically mostly been bad for the public and for innovation.

  • (Score: 3, Informative) by krishnoid on Thursday October 06 2016, @08:23PM

    by krishnoid (1156) on Thursday October 06 2016, @08:23PM (#411226)

    Allergist's offices and pharmacies currently have coupons to fill an Epi-pen prescription effectively for free ($0 copay). They're normally $150 or something with insurance.

    I vaguely suspect this is because this issue is currently front and center. As such, if you/someone you know need to replace an old Epi-pen or get an extra one, I'd recommend calling your allergist or pharmacist ASAP before this exits the news cycle and they start jacking up the prices again.