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Epipen: An public health policy issue for the ages

March 13, 2017

Anaphylaxis is the severe and sudden onset of an allergic reaction triggered by allergies to a specific food, medication, insect bite/sting and/or latex. According to a press release by The Asthmas and Allergy foundation of America (AAFA), anaphylaxis is estimated to occur 1 in 50 Americans although it may be higher at 1 in 20. AAFA found many of these at risk individuals were not prepared to react to a reaction episode, due to the lack of ownership of an epinephrine auto-injector pen. Reasons for lack of ownership were not cited however in the past year attention has been drawn to its cost. Mylan, the #1 producer of the over the past 10 years, with their patented epinephrine auto-injector delivery system, the Epipen.epipen-price-under-mylan

The Business Insider performed a cost analysis of the Epipen, citing a market price increase from $100 in 2007 to $600 in 2016. Mylan’s has had few competitors. Their main competitor was Auvi-Q by Kaleo until its recall in 2015. One competitor still exists on the market today, Adrenaclick by amedra pharmaceuticals with a price tag of approximately $200 with a good prescription coupon.

The FDA has made it easier for Mylan to hike up their prices by limiting manufacturer competition through the recall or blockage of other epinephrine auto-injector devices as well as the back log for generic drugs that has been occurring producing a delay of competitors entering the market. Such politics granted Mylan the ability to increase their prices astronomically however in this past summer they received extreme backlash from two major stakeholders. Congress asked Mylan CEO to justify Epipen price hikes and the dropping of the Epipen coverage by Cigna, a major insurance company. This pushback motivated Mylan to create a generic version of this drug delivery system as well as patient coupons (up to $300) in coverage of Epipen costs to address concerns about its price. These are steps in the right direction however there needs to be more action to keep advocate for whose healthcare coverage still does not grant them the ability to pay $300 or less in out-of-pocket expenses.

I challenge the FDA to uphold their mission to protect the public’s health by ensuring safety, efficacy and security of human drugs and medical devices while accelerating innovation to make medical products more effective, safer and more affordable. The FDA must amend their current policies and procedures to promote the presence of competitors for safe and effective epinephrine auto-injector pens to eradicate the monopoly. This can be done through the overhaul of the generic drug backlog to funnel competitors into the market as well as looking for additional ways for those without adequate health insurance coverage to more affordable epinephrine auto-injector pens and discounts. I challenge competitors to propose refillable epinephrine auto-injector pens, like Dr. Cathleen London in Maine, to provide patients with an feasible alternative. A refillable pen will drastically cut down on the burden of cost for those American citizens whose lives depend on the ownership and access to epinephrine auto-injector pens in case of an anaphylactic shock episode.