Companies’ Failure to Compete with EpiPen’s Technology Sticks Patients with a Difficult Choice

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By: Sarah Wenrich,

EpiPen, a product produced by Mylan Pharmaceutical, has become a household word in the last decade thanks to its reliable, life-saving technology that can be used to easily and safely administer epinephrine to someone experiencing anaphylaxis.[1] However, as EpiPens have become more well known, their prices have also increased over 500% within the last ten years,[2] even though the only noticeable difference was the addition of a flip-top cap on the case. [3] While the EpiPen’s widespread distribution is crucial in case of emergency, this extraordinary increase in price has caused patients who are in need of the product to refrain from filling their prescriptions because they cannot afford the cost.[4] The FDA has said that they will speed up the approval process for competitors or generic versions of the EpiPen[5], but the technology behind the EpiPen makes that much easier said than done. [6]

Most recently, Teva Pharmaceuticals submitted a product to the FDA that would directly compete with the EpiPen, but it was rejected in March of 2016. [7] While the reasons behind the rejection have not been made public, it has been speculated that it had to do with the design of the cap. Teva’s model had a cap that had to be unscrewed before use, whereas Mylan’s EpiPen does not.[8] This is an aspect of the design that Mylan actively lobbied against while Teva was awaiting approval. [9] Mylan reasoned that having to screw off the cap in an emergency could be confusing[10], but their own product has not been foolproof. There have been instances of patients confusing the needle end in emergencies and stabbing their thumbs instead of their thighs. [11]

Other companies have created competing products, but insurance companies refused to cover them, forcing the pharmaceutical companies to discontinue their production. [12] Adrenaclick was one of the products originally pulled from the market for this reason, but it has since returned.[13] Even with Adrenaclick back in the market, Mylan continues to hold 90% of the market share on epinephrine auto-injectors.[14] Contributing to this near monopoly is the fact that unlike most medical prescriptions where the pharmacist can swap out a name brand drug for a generic, the FDA has made it illegal for pharmacies to substitute alternatives, such as Adrenaclick, for the EpiPen.[15]

Perhaps most concerning aspect of the outrageous price increase of the EpiPen is the fact that people have begun to create their own DIY versions of the life-saving product, as they cannot afford to fill their prescriptions. [16] A group of men have created a YouTube video on how to build your own “EpiPencil” with items that you can purchase at the store, with the exception of the liquid epinephrine, which requires a doctor’s prescription.[17] Its design is bulky, but the video shows that it will adequately administer the drug in an emergency for less than $35.[18] However, patients and doctors alike are aware of the dangers that this could present in an emergency[19]. The “Epipencil” faces the hurdle of being unable to accurately administer the correct dosage of the drug, in addition to presenting other concerns associated with creating your own medical device, such as issues with sterilization.[20]

This potentially dangerous alternative to which people have turned showcases just how imperative the drug is to people with allergies that cause anaphylaxis. The patent for EpiPen’s design expires in 2025,[21]but it is clear that something must be done to combat EpiPen’s price hike before then. Right now, people with allergies that result in anaphylaxis have three choices: they can shell out $608 annually for an EpiPen, create their own EpiPencil for under $35 and face a slew of health risks, or hope that they do not come into contact with whatever it is that causes their anaphylaxis. For people who have insurance that covers the cost of the EpiPen or are financially able to foot the bill, the choice is an easy one. For others, it is a difficult choice that they should not have to make.

 

[1] See About EpiPen Auto-Injector, EpiPen, http://www.epipen.com/en/about-en/about-epipen (last visited Oct. 1, 2016).

[2] See Beth Mole, EpiPen maker CEO to seething lawmakers: We’re doing the world a favor, Ars Technica (Sept. 22, 2016, 2:25 PM), http://arstechnica.com/science/2016/09/epipen-maker-ceo-to-seething-lawmakers-were-doing-the-world-a-favor/.

[3] See Meghana Keshavan, 5 reasons why no one has built a better EpiPen, STAT (Sept. 9, 2016), https://www.statnews.com/2016/09/09/epipen-lack-of-innovation/.

[4] See Rising cost of potentially life-saving EpiPen puts pinch on families, CBS News (Aug. 16, 2016, 7:02 AM), http://www.cbsnews.com/news/allergy-medication-epipen-epinephrine-rising-costs-impact-on-families/.

[5] See Mole, supra note 2.

[6] See Keshavan, supra note 3.

[7] See Jonathan Newman, The Lack of EpiPen Competitors is the FDA’s Fault, Mises Institute (Aug. 24, 2016), https://mises.org/blog/lack-epipen-competitors-fdas-fault.

[8] See Michael Gibney, Could EpiPen’s plastic cap be Mylan’s secret weapon?, FiercePharma (Sept. 1, 2016, 4:21 AM), http://www.fiercepharma.com/drug-delivery/could-a-plastic-cap-epipen-have-given-mylan-its-market-dominance.

[9] See id.

[10] See id.

[11] See Keshavan, supra note 3.

[12] See Newman, supra note 7.

[13] See id.

[14] See Mole, supra note 2.

[15] See Brett Trout, Government is to blame for the skyrocketing price of EpiPens, not patents, IPWatchdog (August 29, 2016), http://www.ipwatchdog.com/2016/08/29/government-blame-price-epipens-patents/id=72412/.

[16] See Larson, supra note 16.

[17] See id.

[18] See id.

[19] See id.

[20] See id.

[21] See Gibney, supra note 8.

Photo Source:

http://media2.s-nbcnews.com/i/MSNBC/Components/Video/201608/a_101_epipen_price_160823.jpg