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

Ruth Lopert ruth.lopert at gmail.com
Sun Oct 2 20:59:32 PDT 2016


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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