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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...


Original Submission

Related Stories

EpiPen's Price Increased 400% since 2008 97 comments

EpiPen's price has ballooned about 400% since 2008, rising from about a $100 list price to $500 today. The EpiPen is one of the most important life-saving medical innovations for people with severe food allergies—which affect as many as 15 million Americans and 1 in 13 children in the United States. But its price has exploded over the last decade despite few upgrades to the product itself. The product's lack of competitors is likely a significant driver of the costs. [...] [The] EpiPen enjoys a near-monopoly on the market with annual sales of more than $1.3 billion and nearly 90% U.S. market share.

At Fortune, NYT, The Hill.


Original Submission

AllergyStop: $50 EpiPen is Production-Ready but... 35 comments

AlterNet reports

The [EpiPen], which millions of Americans depend on, was invented in the 1970s by engineer Sheldon Kaplan[PDF], who died seven years ago in modest surroundings amid obscurity. But Kaplan's patent made its way into [the] Netherlands-based drug maker Mylan, which, since 2007, has jacked up the price of the spring-loaded injector from $57 a shot to $300.

[...] The high price [...] caught the attention of Dr. Douglas McMahon. The 38-year-old allergy specialist in St. Paul, Minnesota, has been thinking about how to improve on the EpiPen and to do so in a way that's affordable.

[...] McMahon saw that the EpiPen device was not only overpriced for what it does but also was too big to be easily carried in a pocket. For the past couple of years, he has been tinkering with injection-device components in his lab. And the result of his work is AllergyStop [1], an injection prototype that's small enough to fit on a key chain. McMahon claimed his device is as effective as the EpiPen and can be marketed and sold for about $50.

But, even though McMahon's device has been production-ready for the past two months, the steps he must take to get the device approved will cost him about $2 million and it will potentially take him years to go through all the hurdles required by the U.S. Food and Drug Administration for possible approval of his invention.

[1] All content is behind scripts. archive.li will run those for you.

Previously:
EpiPen's Price Increased 400% since 2008


Original Submission

NIH Reverses Allergy Guidelines, Recommends Feeding Peanuts to Infants 18 comments

In a press release Thursday, the National Institutes of Health reported an addendum to its official guidelines for Diagnosis and Management of Food Allergy. The specific change is intended to address the precipitous rise in peanut allergies which has occurred recently. For many years, parents have been strictly advised to avoid exposing babies to peanuts, eggs, and other potential allergen foods, on the hypothesis that early exposure could be dangerous and exacerbate problems in those children likely to develop allergies.

The new guidelines are a complete reversal in that the NIH now recommends earliest exposure (4 to 6 months) for children at most risk of developing allergies, such as those with severe eczema and/or known egg allergies. Other children should also have peanuts -- though not whole ones, which can be a choking hazard -- introduced into diets freely along with solid foods. The new guidelines are based on results from the landmark Learning Early About Peanut Allergy (LEAP) study. From the NIH press release:

"The LEAP study clearly showed that introduction of peanut early in life significantly lowered the risk of developing peanut allergy by age 5. The magnitude of the benefit and the scientific strength of the study raised the need to operationalize these findings by developing clinical recommendations focused on peanut allergy prevention," said Daniel Rotrosen, M.D., director of NIAID's Division of Allergy, Immunology and Transplantation.

CNN reports on the history of the LEAP study, noting that there was an earlier practice in Israel to expose children to peanuts as early as possible. Anecdotally, these children had a much lower frequently of allergies than Israeli children raised in the UK. The LEAP study thus assigned over 600 children randomly to a group with early exposure or a group which avoided peanuts completely for the first 5 years of life. The results were striking:

All the children participating in the study were at high risk of peanut allergy due to family history or having eczema or egg allergy themselves, said Nepom [one of the developers of the LEAP study]. At age 5, the children in both groups were given peanuts and observed, Nepom said: Eighteen percent of the children who had been avoiding peanuts had a peanut allergy at age 5, compared with only 1% of the children who had been introduced to peanut butter or Bamba early in life. "This showed that early introduction of peanut flour had over 80% prevention effect," Nepom said.

The study and the new NIH guidelines represent one of the most scientifically rigorous rationales to reconsider allergy guidelines in general. Proponents of early exposure to problematic foods, along with the hygiene hypothesis, claim that the obsession with avoiding exposure to potential allergens in early life has actually caused the current epidemic of allergies. Approximately 1 in 13 children in the U.S. has a food allergy; over 2% alone have peanut allergies. While death from anaphylaxis after exposure is relatively rare, various studies indicate that peanuts are likely the most common trigger in children and frequently result in hospital visits. The NIH policy change is also quite relevant, following the extended national debate on cost of anaphylaxis medication, particularly the outrageous prices for EpiPens (see SoylentNews coverage here, here, and here).


Original Submission

CVS Partners With Impax to Sell Low-Cost Generic Epipen Alternative 17 comments

Just months after an outcry about a price hike for the life-saving "Epipen", CVS pharmacies will begin carrying a new generic injector at a cutthroat price:

Pharmaceutical giant CVS announced Thursday that it has partnered with Impax Laboratories to sell a generic epinephrine auto-injector for $109.99 for a two-pack—a dramatic cut from Mylan's Epipen two-pack prices, which list for more than $600 as a brand name and $300 as a generic.

The lower-cost auto-injector, a generic form of Adrenaclick, is available starting today nationwide in the company's more than 9,600 pharmacies. Its price resembles that of EpiPen's before Mylan bought the rights to the life-saving devices back in 2007 and raised the price repeatedly, sparking outcry. [...] The price of $109.99 for the alternative applies to those with and without insurance, CVS noted. And Impax is also offering a coupon to reduce the cost to just $9.99 for qualifying patients. [...] Meanwhile, backlash to Mylan's price hikes continue. This week, Cigna, a top health insurance company, said that it will no longer cover Mylan's brand name EpiPen—it will only cover the generic, which was rolled out in December.

Previously: AllergyStop: $50 EpiPen is Production-Ready but...
Mylan Overcharged U.S. Government on EpiPens


Original Submission

EpiPen Maker is Facing Shareholder Backlash 13 comments

Dr. Lowe, from In the Pipeline, writes about the company responsible for EpiPen, with quotes taken from The New York Times:

To understand Mylan’s culture, consider a series of conversations that began inside the company in 2014.

In (2014) meetings, the executives began warning Mylan’s top leaders that the price increases seemed like unethical profiteering at the expense of sick children and adults, according to people who participated in the conversations. Over the next 16 months, those internal warnings were repeatedly aired. At one gathering, executives shared their concerns with Mylan’s chairman, Robert Coury.

Mr. Coury replied that he was untroubled. He raised both his middle fingers and explained, using colorful language, that anyone criticizing Mylan, including its employees, ought to go copulate with themselves. Critics in Congress and on Wall Street, he said, should do the same. And regulators at the Food and Drug Administration? They, too, deserved a round of anatomically challenging self-fulfillment.

[...] As the article says, the company has decided that all the criticism is just the cost of doing business, and that their business is selling EpiPens at the highest cost they can. Bad press, upset parents, calls for them to change – none of that means much.

[...] Another thing that happens when you operate this way is that other government agencies get motivated to take a closer look at you. Last fall, Mylan paid $465 million to settle a misclassification problem that led to them getting higher rebates than they should have on EpiPens distributed through Medicare. But now it appears that there’s another $1.27 billion involved, according the the Health and Human Services Office of the Inspector General.

[...] As it happens, some of the company’s investors are trying to replace the board members, and just this morning, ISS (Institutional Shareholder Services) came down on their side. They’re recommending that shareholders vote against ten directors and against ratifying the compensation plans for the top executives. That’s a pretty big deal, since ISS handles the proxy voting for a lot of big investors and funds, and if given the go-ahead can vote things en masse. This, you can be sure, is a cause for concern in the upper suites, and it should be.

http://blogs.sciencemag.org/pipeline/archives/2017/06/12/mylan-begins-harvesting-the-crop-its-sown
https://www.nytimes.com/2017/06/04/business/angry-about-epipen-prices-executive-dont-care-much.html?_r=1
http://www.fiercepharma.com/pharma/mylan-investors-rally-votes-against-chairman-coury-and-his-97m-pay-package

Previous Coverage of Mylan and their Practices:
https://soylentnews.org/article.pl?sid=16/10/06/021244
https://soylentnews.org/article.pl?sid=16/08/23/0136202


Original Submission

U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company 29 comments

Health systems representing around 500 U.S. hospitals have formed a not-for-profit pharmaceutical manufacturer called Civica Rx. The drugs will be cheap, and the CEO will not receive a paycheck:

A drugmaking venture backed by major U.S. hospitals has picked a chief executive officer, hastening the arrival of another threat to generic pharmaceutical manufacturers.

Martin VanTrieste, 58 and a former top executive at biotechnology giant Amgen Inc., will run the organization, a not-for-profit called Civica Rx. Dan Liljenquist, 44 and an Intermountain Healthcare executive, will be chairman. Health systems with a total of about 500 hospitals -- including Intermountain, HCA Healthcare Inc., Mayo Clinic and Catholic Health Initiatives -- will help govern the venture, alongside several philanthropies.

Civica Rx will work to combat drug shortages and skyrocketing prices for some treatments given in hospitals by manufacturing generics or contracting with other firms to make them. Generic drugmakers have faced scrutiny for raising the prices of certain older drugs, particularly when hospitals lack alternatives. The supply chain for such treatments has also been vulnerable to disruptions, leading to persistent shortages.

"Civica Rx will first seek to stabilize the supply of essential generic medications administered in hospitals," the group said in a statement. "The initiative will also result in lower costs and more predictable supplies of essential generic medicines."

The venture, announced by Intermountain in January, said it plans to have its first products ready by as early as next year. It's focused on a group of 14 drugs given in hospitals, but a spokesman for the group declined to identify them. Liljenquist said that the drugs are in categories such as pain relief, antipsychotics, antibiotics and cardiovascular treatments, including drugs that are stocked on so-called crash carts used in emergencies.

Also at NPR, CNBC, The Washington Post, and Forbes.

Related: The Cheerios Theory of Branded Medicine
Mylan Overcharged U.S. Government on EpiPens
Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Amazon, Berkshire Hathaway, and JPMorgan Chase to Offer Their Own Health Care to U.S. Employees
Analysts Question Whether Curing Patients is a Sustainable Business Model
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]


Original Submission

Martin Shkreli Accused of Running Business From Prison With a Smuggled Smartphone 32 comments

Martin Shkreli continues to run business from prison, report says

Martin Shkreli reportedly runs his pharmaceutical company from prison on a contraband smartphone. Shkreli continues to run the remains of the drug company that once earned him the title of most hated man in America, according to a story in the Wall Street Journal. He was convicted of securities fraud and conspiracy in 2017. He has served 16 months of a seven-year sentence in federal prison.

Shkreli is reportedly running Phoenixus AG, formerly known as Turing Pharmaceuticals. In 2015, when Shkreli was the CEO, Turing raised the price of the lifesaving drug Daraprim used by AIDS patients from $13.50 a pill to $750 a pill. The price hike sparked a public outcry.

The Journal says that Shkreli anticipates the company will grow more successful while he's in prison. He believes the company, of which he owns 40%, could be worth $3.7 billion by the time he gets out of prison.

On one recent phone call, Shkreli fired Phoenixus CEO Kevin Mulleady, the Journal reported. Shkreli reportedly later changed his mind, agreeing to suspend Mulleady rather than fire him.

Cartoon villain performance art.

Previously: Martin Shkreli Points Fingers at Other Pharmaceutical Companies
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors

Related: Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill
Mylan Overcharged U.S. Government on EpiPens
EpiPen Maker is Facing Shareholder Backlash
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company


Original Submission

FTC: Shkreli May Have Violated Lifetime Pharma Ban, Should be Held in Contempt 10 comments

https://arstechnica.com/science/2023/01/ftc-shkreli-may-have-violated-lifetime-pharma-ban-should-be-held-in-contempt/

Infamous ex-pharmaceutical executive Martin Shkreli is yet again in trouble with the Federal Trade Commission, which announced today that the convicted fraudster has failed to cooperate with the commission's investigation into whether he violated his lifetime ban from the pharmaceutical industry by starting a company last year called "Druglike, Inc."
[...]
At the center of the dispute is whether Shkreli's co-founding of Druglike runs afoul of his lifetime ban from the pharmaceutical industry, which was in response to Shkreli's infamous move to raise the price of the cheap, life-saving anti-parasitic drug, Daraprim, from $17.50 a pill to $750 a pill in 2015.
[...]
The FTC also noted in its court filing that Shkreli has so far failed to pay any of the $64.6 million in disgorgement he was ordered to pay alongside his lifetime ban.

Previously:
Martin Shkreli Launches Blockchain-Based Drug Discovery Platform
Martin Shkreli Accused of Running Business From Prison With a Smuggled Smartphone
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Points Fingers at Other Pharmaceutical Companies

Related:
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
EpiPen Maker is Facing Shareholder Backlash
Mylan Overcharged U.S. Government on EpiPens
Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill


Original Submission

Shkreli Tells Judge His Drug Discovery Software is Not for Discovering Drugs 12 comments

https://arstechnica.com/science/2023/02/shkreli-tells-judge-his-drug-discovery-software-is-not-for-discovering-drugs/

In an effort to avoid being held in contempt of court, former pharmaceutical executive and convicted fraudster Martin Shkreli made an eyebrow-raising argument to a federal judge Friday, stating that his company Druglike, which he previously described as a "drug discovery software platform," was not engaged in drug discovery. As such, he argued he is not in violation of his sweeping lifetime ban from the pharmaceutical industry.

Last month, the Federal Trade Commission and seven states urged a federal judge in New York to hold Shkreli in contempt for allegedly failing to cooperate with an investigation into whether he violated the ban. The FTC said Shkreli failed to turn over requested documents related to Druglike and sit for an interview on the matter.

In the filing Friday, Shkreli claims that he responded to the FTC's requests "promptly and in good faith."

Previously:
FTC: Shkreli May Have Violated Lifetime Pharma Ban, Should be Held in Contempt
Martin Shkreli Launches Blockchain-Based Drug Discovery Platform
Shkreli Released From Prison to Halfway House After Serving <5 of 7 Years
Martin Shkreli Accused of Running Business From Prison With a Smuggled Smartphone
Sobbing Martin Shkreli Sentenced to 7 Years in Prison for Defrauding Investors
Martin Shkreli's $5 Million Bail Revoked for Facebook Post Seeking Hillary Clinton's Hair
Martin Shkreli Lists Unreleased Wu-Tang Clan Album on eBay
Martin Shkreli Convicted of Securities Fraud Charges, Optimistic About Sentencing
Martin Shkreli Points Fingers at Other Pharmaceutical Companies

Related:
"Pure and Deadly Greed": Lawmakers Slam Pfizer's 400% Price Hike on COVID Shots
U.S. Hospitals Band Together to Form Civica Rx, a Non-Profit Pharmaceutical Company
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated]
EpiPen Maker is Facing Shareholder Backlash
Mylan Overcharged U.S. Government on EpiPens
Drug Firm Offers $1 Version of $750 Turing Pharmaceuticals Pill


Original Submission

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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.

    • (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) 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.