Editorial: We Disagree with the Petition to Make Epinephrine an OTC Drug

Dillon Mueller’s story is a horrific tragedy. The 18 year-old Wisconsinite perished in 2014 from an anaphylactic reaction caused by a bee sting despite never having been diagnosed with an allergy. We extend our deepest sympathies to his family and encourage you to read about Dillon on the website his parents, Angel and George Mueller, established to memorialize him.

Because he was never diagnosed with an allergy, Dillon was never prescribed epinephrine, so there was no auto-injector on-hand to administer the only drug that might have saved his life.

In an effort to foster much needed change, the Muellers have started a petition urging the FDA to designate epinephrine an “Over the Counter” (OTC) drug, i.e. one that is readily available without a prescription. The premise of the petition is that more people would carry epinephrine if it was available without a prescription, and more people carrying would imply a greater chance of epinephrine being available when a victim suffering anaphylaxis isn’t carrying his own.

While we appreciate the Muellers’ efforts to help prevent others from suffering the same fate as Dillon’s, we believe this effort is misguided.

Epinephrine auto-injectors are expensive (costing hundreds of dollars) with a relatively short time-to-expiration (generally 12 months or less.)  As such, we do not believe many people would purchase the drug unless they were directed to do so by a physician. If they were to do so, administering the drug to someone else in an emergency might actually expose them to litigation due to the present tort laws of many jurisdictions.

We are also concerned that, once given OTC designation, epinephrine would cease to be covered by many insurers, leaving even more families to struggle with the high costs of the medication.

Instead, we support legislation that mandates stock epinephrine in ambulances and all places of public accommodation, like restaurants, cafeterias, malls, movie theaters – everywhere you currently find cardiac defibrillator AEDs. Such legislation should also include the necessary Good Samaritan provisions to shield those who administer the drug in good faith from litigation, and provide the funding to stock and replenish the drug and support training in proper administration, much like CPR training is readily available today.

We believe this would be a much more effective and deterministic way to achieve the Muellers’ goal – that of extending the safety net of epinephrine availability – so that Dillon’s story is not repeated.

What do you think? Let us know by commenting below.

Note of disclosure: Mylan is an advertiser with SnackSafely.com
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15 COMMENTS

  1. Yes, I agree. That makes sense. I wonder, however, if there us a way folks could get it for their home first aid kits.

    • Good point about being able to have it in home First Aid Kits. We have two available at all times for our daughter’s severe food allergies… but for someone who may suffer unknowingly at home (like the one commenters father – above)… having one or two available in a first aid kit would be invaluable!

  2. i think you make well thought out, strong arguments. I wish I read your article before I got the change.org petition! I couldn’t think off hand of the negatives to having it readily available, so I signed it. I think with the stipulations you outline, Epi could be more available and life saving.

  3. Not sure how having epi pens available just in public places would prevent the circumstances in Dillon’s case. My father had a reaction similar to Dillon’s at our home, alone. He had no history of severe reaction to insect stings so had no epinephrine in home. My father struggled to our phone and dialed 9-1-1, but passed out before speaking to operator. Fortunately the ambulance and hospital was a short distance from our home and 9-1-1 services could identify our house as it was a home phone. My father was in a coma though. In regards to the cost, yes it is expensive, many of us are paying for two to three sets a year at near cost but we do it. I hope the cost will go down with competition. But from our experience having a set in the home even past expiration date is better then none.

  4. I agree. Cease in insurance coverage is unimaginable having 3 allergic kids. That will put a lot of kids in jeopardy. Who knows epi might not be able to give discount then also. We definitely need to take the time to think things through. Huge ramifications possibly. On a much smaller scale. I remember when Claritin was a copay and now it’s much more expensive otc. Still bothers me.

  5. While there are likely and infinite number of opinions, we must account for simple economics. Should supply increase from the drug being OTC, the cost would decrease. While the premise that more people would buy needs verification, it is likely – take Claritin for example – which experienced a cost decline as supply (demand) increased. Further, I question whether administration of epinephrine exposes anyone to legal action above that of any other OTC drug that may be administered, and makes me question how making it available in public places differs at all. Are restaurants trained in administrating the drug? The answer is no and, therefore, OTC is exactly the same.

  6. Epinephrine is not expensive. A 1 ml vial (more than the equivalent of 3 Epi-pens) runs around $2. It is the delivery device that is ridiculously expensive. Solutions could be to train individuals or others to draw up the epinephrine from a vial (much like a diabetic draws up insulin)for administration. The argument against that is that in a high pressure situation that mistakes could be made, but at least we would give individuals a fighting chance by making it more affordable.

    • While that sounds like a reasonable solution, it is not as easy as it sounds. My sister had to do that before the delivery devices existed. What I remember was that it was less available because the vial would have to be refrigerated making it difficult to just carry with her. Perhaps it is different now, that was 40 years ago. I agree with the author. Until the cost goes down on the entire device and given that it is a powerful medication, making it similar to AED would be a solution that make more sense.

  7. I fully agree with your arguments. Additionally, I’m sure there would be abuse of the Epi’s. So many places now carry emergency use Epinephrine that it doesn’t make sense to make it OTC now. For those that want one for home safety, I’m sure your primary physician would write a script for you.

  8. I do agree with the article also. I just don’t think it would encourage more people to carry epinephrine. As we all know, it also has to be treated with special care to not be ruined by temperature which would be another issue. In the long run, it does cost more for us when drugs go OTC. I also have 3 nut allergic children. As for the stock epinephrine, I live in Iowa where a law was recently passed. I was asking the school nurse if the schools were going to stock it and the answer was no. Unfortunately she said that there were no local doctors who would sign a prescription for a nonspecified patient due to liability so basically the law is useless. The laws need somehow address this problem.

  9. Perhaps I would have agreed a couple of years ago but not today. The insurance situation is already as bad as it can get as a result in the rising cost of the epi-pens (for no defensible reason). I recently started ordering my epi-pens from Canada. $100 versus $800 in the US and you don’t need a prescription. Canadians with a prescription get them for under $50. I’ve never paid that little even with my insurance coverage.

    With that said, I want the option to be able to pay $800 on the spot if I need it.

  10. All valid concerns & points- I do agree with most 🙂 When I saw this petition, my immediate thoughts went to how would correct storage & dosage be explained correctly to avoid spoilage, how would this be covered by insurance by those who can have it covered…so many questions but ultimately, in my heart, I feel the need to make sure anyone & everyone can get to it if they need it.

  11. Epinephrine is not an expensive drug. The EpiPen delivery system is patented by Mylan and it is this patent that allows Mylan to set the exorbitant cost of the drug.

  12. According to Wikipedia https://en.wikipedia.org/wiki/Epinephrine_autoinjector the delivery system was developed by the US military. Mylan somehow patented the pen that was based on a device which was invented and paid for by the US government. Now Mylan has a monopoly and there is nothing anyone can do. They can charge whatever they want for it. Some say this is capitalism. is it?

    My wife got bitten by fire ants recently and ended up at emergency room hardly breathing. She was advised to carry the pen with her at all times. I guess I am biased having discovered the price of the drug. Its amazing that this is not covered by insurance given that this is a life saving medication for those with allergies. If this is capitalism, it is the worst example of it. Why the hell this costs so much less in Canada and England? What these governments do different from the US government? Last time I checked they both have economies based on a free market.

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