[Ip-health] Fwd: On Epi-Pen : The Durham-Humphrey Amendment

Michael H Davis m.davis at csuohio.edu
Mon Oct 3 08:26:56 PDT 2016


I don't think this is a legislative problem. It's information, thankfully, since our legislature is broken. Although it could be fine state by state also.

Doctors don't know to prescribe the cheaper version. And if you think there are any dangers on switching pens, this pen could be operated by an. I'll try to attach the training video.






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-------- Original message --------
From: Ruth Lopert <ruth.lopert at gmail.com>
Date: 10/3/16 01:00 (GMT-05:00)
To: George Carter <gmcfiar at gmail.com>
Cc: ip-health <ip-health at lists.keionline.org>
Subject: Re: [Ip-health] Fwd: On Epi-Pen : The Durham-Humphrey Amendment

Its available w/o prescription (albeit BTC) in Australia too.
Down-scheduling Epipen is one thing but repealing Durham-Humphrey would be
throwing the baby out with the bathwater.


On Wed, Sep 28, 2016 at 2:39 PM, George Carter <gmcfiar at gmail.com> wrote:

> Thoughts? Is repealing this a good idea? Or perhaps amending it. (Which
> under current circumstances seems implausible.) Makes a good point, sadly,
> about the uselessness of the badgering without any change or impact.
>
> http://www.eurasiareview.com/28092016-one-solution-to-
> epipen-crisis-repeal-durham-humphrey-oped/?utm_source=
> feedburner&utm_medium=email&utm_campaign=Feed%3A+eurasiareview%2FVsnE+%
> 28Eurasia+Review%29 <http://www.eurasiareview.com/
> 28092016-one-solution-to-epipen-crisis-repeal-durham-
> humphrey-oped/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed:+
> eurasiareview/VsnE+(Eurasia+Review)>
>
>  <http://www.eurasiareview.com/28092016-one-solution-to-
> epipen-crisis-repeal-durham-humphrey-oped/?utm_source=
> feedburner&utm_medium=email&utm_campaign=Feed:+
> eurasiareview/VsnE+(Eurasia+Review)>
> One Solution To EpiPen Crisis: Repeal Durham-Humphrey – OpEd
>
> By John R. Graham <http://www.eurasiareview.com/author/john-r-graham/>
> September 28, 2016
>
> Posturing politicians on Capitol Hill conducted a hearing a few days ago <
> http://www.forbes.com/sites/emilywillingham/2016/09/21/
> mylan-ceo-bresch-grilled-on-capitol-hill-over-epipen-debacle/#2e4ef3434349>
> during which they grilled Heather Bresch, CEO of Mylan N.V., maker of
> EpiPens. Prices of EpiPens have skyrocketed in the past few years (which I
> have discussed here <http://blog.independent.org/2016/09/12/epipen-a-case-
> study-in-health-insurance-failure/> and here <http://blog.independent.org/
> 2016/08/30/epipen-a-case-study-of-government-harm/>).
>
> The politicians were more interested in wagging their fingers and
> tut-tutting at Ms. Bresch for the amount of money she has made, than
> actually figuring out a way to lower the price of EpiPens. (By the way, Ms.
> Bresch testified she has no intention of reducing prices in response to
> their badgering.)
>
> If the politicians ever decide to do something serious, here is a
> proposal: Repeal Durham-Humphrey!
>
> Huh? That doesn’t sound like much of a rallying cry. The Durham-Humphrey
> Amendment gave the federal government (via the Food and Drug
> Administration) the power to decide whether a drug is available only by
> prescription or over-the-counter (OTC). The law passed in 1951, half a
> century after the FDA was instituted. Even if you believe Congress should
> keep drugs off the market until the FDA has proven their “safety and
> efficacy” (which I do not), that does not necessarily imply the FDA should
> decide whether the drug should be prescribed or dispensed OTC.
>
> The Durham-Humphrey Amendment was passed to increase control over the
> distribution of amphetamines <http://www.fda.gov/downloads/
> aboutfda/whatwedo/history/oralhistories/selectedoralhistorytranscripts
> /ucm265382.pdf>, but it quickly metastasized to a general federal control
> over prescribing. Whether it solved the inappropriate consumption of
> amphetamines is not the topic of this entry, but the continuing flurry of
> legislation <https://www.healthcarelawtoday.com/2016/
> 03/29/four-distinct-federal-and-state-policies-addressing-
> prescription-opioid-abuse/> attempting to control the opioid epidemic
> suggests government has not quite figured out how to deal with drug abuse.
>
> Anyway, what would happen if manufacturers had the ability to decide how
> to distribute their drugs, via prescription or OTC? EpiPen has one (much
> less expensive) competing product, Adrenaclick (manufactured by Amedra
> Pharmaceuticals). However, EpiPen is better known than Adrenaclick and is
> used colloquially (and wrongly) as a generic name (like Coke and Kleenex
> are similarly abused).
>
> So, it is hard to break through doctors’ prescribing habits to induce them
> to prescribe the less expensive Adrenackick (especially because U.S.
> doctors are notoriously ill-informed about how much their patients will
> have to pay for drugs). I suspect if it were free to do so, Amedra might
> move Adrenaclick OTC to get closer to patients.
>
> Devon Herrick of the National Center for Policy Analysis explains <
> http://healthblog.ncpa.org/epipen-a-case-study-in-whats-
> the-matter-with-health-care/comment-page-1/#comment-386023> that about
> one billion dollars’ worth of EpiPens are thrown out unused in the United
> States, because they need to be immediately at hand but expire after about
> a year. Pharmacies have evolved into very consumer-friendly retail
> environments – almost more like supermarkets or department stores than
> old-chemists’ shops. If patients knew they could walk in and grab an
> Adrenaclick like a tube of toothpaste, they would not need to stockpile as
> many injectors as they do when they have to go to a physician for a
> prescription.
>
> Because so many patients are now paying full price for their
> prescriptions, this move would grab patients’ attention, and Mylan would
> likely have to respond by moving EpiPen OTC.
>
> Does this sound too risky? Not in Canada, where both injectors are OTC and
> EpiPen sells for about $80 (U.S.), about one-eighth the price in the United
> States. (OTC drugs are sold in a free market in Canada, outside the
> single-payer system.)
>
> When it comes to regulating EpiPens, the United States should follow
> Canada’s lead.
>
> This article was published at The Beacon <http://blog.independent.org/
> 2016/09/27/one-solution-to-the-epipen-crisis-repeal-durham-humphrey/>
>
> John R. Graham is Senior Fellow at the Independent Institute and a Senior
> Fellow at the National Center for Policy Analysis. Formerly Vice President
> at the Advanced Medical Technology Association (AdvaMed), he previously
> directed health-policy research at the Pacific Research Institute and the
> Fraser Institute. In prior positions he served as Assistant Vice President
> at Kidder, Peabody Securities Company; Associate at Goldman Sachs and
> Company; Political and Military Analyst for the United Nations Operation in
> Somalia; Development Consultant for Covenant House Vancouver; and Captain
> in the Canadian Army. He received his Bachelor of Arts (Honors) in
> economics and commerce from the Royal Military College of Canada and his
> M.B.A. from the University of Cologne, Germany. He is also Senior Fellow at
> the Fraser Institute as well as Adjunct Fellow for the Mackinac Center for
> Public Policy.
>
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