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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) <reversethis-{moc ... ksonsiwnohtanoj}> 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.

    Starting Score:    1  point
    Karma-Bonus Modifier   +1  

    Total Score:   2  
  • (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).