Food Allergy and Your Kiddo

Inside the FDA Panel on Epinephrine Access: What Families Need to Know

• Alice Hoyt, MD

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Dr. Alice Hoyt discusses her recent experience speaking at a panel in Washington, D.C., focused on improving access to epinephrine for anaphylaxis. She emphasizes the importance of making epinephrine available over the counter and addresses the challenges faced by schools and families in accessing this life-saving medication. Dr. Hoyt also highlights the role of education in ensuring proper use of auto-injectors and shares insights from the FDA's evolving approach to non-prescription drugs.

Keywords

epinephrine, anaphylaxis, FDA, over-the-counter, auto-injectors, education, access, healthcare, medication, allergy

Takeaways

  • Epinephrine should be available over the counter.
  • Education is key to proper use of auto-injectors.
  • Access to epinephrine is crucial for schools and families.
  • FDA is exploring new approaches to non-prescription drugs.
  • Non-medical individuals can learn to use auto-injectors.
  • Cost and insurance barriers affect access to epinephrine.
  • Antihistamines are not a substitute for epinephrine.
  • Proper training can prevent misuse of auto-injectors.
  • Epinephrine is not a habit-forming medication.
  • Collaboration with healthcare providers is essential.

Resources

📖 Navigating Food Allergies: A Parent’s Guide to Care, Coverage, and Confidence by Dr. Alice Hoyt - preorder from Amazon and more

For Parents ➡️ Office Hours for Parents

For Providers ➡️ Food Allergy Pediatric Hub

For Schools ➡️ Code Ana

For Potential Patients ➡️ Hoyt Institute of Food Allergy

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This podcast is the official podcast of the Hoyt Institute of Food Allergy. Information on, within, and associated with this site and Food Allergy and Your Kiddo is for educational purposes only and is not medical advice.

SPEAKER_01:

Hello and welcome to Food Allergy and Your Kiddo. I'm your host, Dr. Alice Hoyt. And today I want to talk with you about a trip that I recently took to Washington, D.C. Um, very fun, kind of chilly, but it was actually really chilly here in Louisiana too. Um, so no big, no big, and totally worth it because the trip was to speak on a panel supported by the FDA, um, hosted by the Duke Morgalis Institute for Health Policy. And uh the title of the panel was Improving Anaphylaxis Outcomes Approaches for Enhancing Access to Epinephrine. And it was a very interesting experience. Um as you may know, I talk about anaphylaxis all of the time. Um, not just when I'm seeing patients, but also with the nonprofit I lead, Codyana. We equip schools, early child care centers, communities to be prepared for medical emergencies like anaphylaxis. And so talking about anaphylaxis and community preparedness, specifically preparedness when you're you're outside of the healthcare system, um, and just access to epinephrine. I mean, I think we all know the horror stories about how much epinephrine can cost. And um, if your doctor doesn't prescribe the one that's on your insurance plan and just all the things, right? So this specific panel, very cool, very cool. It was all about exploring some of those barriers. Uh so I'll put a link in the show notes to where you can access it. But also, if you don't already subscribe to my email list, we have redone the newsletter. It's called Joyful Living. I'm very excited about it. Um, it's very on brand. Like, you know, if you've listened to this podcast, that we are all about less stress, more joy. We are not fear mongers. I say we, I'm talking about me when my amazing friend Pam comes on. She used to be a pretty regular co-host, and now, you know, she has all these amazing things that she's doing in her life. I'm so happy for her, and we're still like besties. She just doesn't come on the podcast all the time. Um, but you know, just tangent, tangent, Pam. Um, getting back to um really focusing on access to Epi and thinking about less stress, more joy, which is totally on brand. Joyful living, go to foodallergy and keto.com, join the newsletter. But when I went to this panel and went in person and spoke, it was one of these like 9 a.m. to 4 30 p.m. things. There were four different panels. What I was thinking about is you. If you have a child who has an IgE-mediated or an anaphylactic food allergy, I'm thinking, how can I be the best advocate for you? How can I advocate for you to be able to have access to the medication that your child may need in case of an allergy emergency? Um, and when you frame where you're coming from or your motivation, of course, it it helps everything become very, very clear. And what was also very interesting, so the entire panel was interesting, like the whole the the whole thing. And you can go, you can watch the whole thing, it's all on the YouTube, um, which also we have a YouTube channel now too, which if you're listening on the audio podcast, awesome. And if you're if you're watching on the YouTube, then you already know there's YouTube. But if you're watching listening on the audio podcast, then you might not know we have a YouTube, but we have a YouTube. Um, and so let's let's talk about this panel. Guys, I'm kind of all over the place today, right? Um it is what it is because I'm also trying to kind of follow these notes that I have for myself, which is important. So in in the opening of this podcast, I'm supposed to say why this mattered. Yeah, I think that's I think that's a good way to start this podcast. Okay, so this Washington, D.C. panel, all about access to epinephrine, why did it matter? Um, it matters because I can't tell you how often I hear about a school not having stock epinephrine and a school nurse not being able to adequately use her or his skill set to treat that patient because they don't have the tool that they need to do so, they don't have the epinephrine. Or when a family comes to me and they are splitting the auto injectors, one goes to school, one stays at home because they can't afford more than one twin pack, or because they've been told that they can't get more than one on their insurance, which also isn't always the case. But really, why this trip was so important is because um, what do they call it? Burying the lead. Really, what this panel was asking about is should epinephrine be available over the counter? And spoiler alert, I do think it should be available over the counter. It was very cool to hear some of the folks from the FDA actually talk through what does it mean for a drug to be over the counter or prescription? Because those are the two options. It's either over-the-counter or prescription. Now you might be thinking, yeah, but things like Pseudofed, you can get them over-the-counter, but then you have to go and show your ID and there's state monitoring and things like that. Um, yes, those things happen. But from the federal level, FDA, there is over-the-counter and there is prescription. Now there is a new caveat over the counter, very new for the FDA that I'll talk about in a minute. But let me get back to why this was actually very important. This was important because people need to have access to a life-saving medication. And how silly is it that now in 2026 the medication could be there at the pharmacy and someone is just not able to get it because they don't have a prescription for it. I mean, I'm just taking a minute to think about that. If if you need epinephrine, which is not a habit-forming medication, it's not one like a controlled substance, it's not any sort of opiate or anything like that. Um, and when it comes to epinephrine, from an auto injector or even the nasal, it is pre-dose. So you're not drawing up the wrong amount. You can only give it one way. You're not trying to give it IV and then you have bad outcomes. Um, even in my office, I stock auto injectors because that's the safest way to administer epinephrine. You don't want to be drawing something up violence or range in the middle of an emergency, right? You just want to have easy to use, easy to use. Um I'll also take a minute to pause here that I am an advisor for one of the auto injector companies. I'm an advisor for Kaleo. Um, I think they're an excellent product. Um I have stocked, I have stocked Audi Qs well before I was ever an advisor for them. I like them because it makes it as user-friendly as possible to use the device. Um, so I like working with them too. Um so what was the panel actually about? I'm trying to follow my notes here, okay? What was the panel actually about? How do we improve access? What are some of those regulatory issues? And probably this is where I was most intrigued because there were some amazing people on this panel on all these, I guess there were four panels, right? And four different topics. And you can go online and look and see what what the different topics were. And my specific panel was tasked with discussing some of the regulatory burdens. And it was very interesting to hear what some of the perceived barriers are, specifically regarding education and what some of the barriers I have experienced. I have had families' experience, I've had school nurses' experience, had um entities' experience, because in many states, non-school entities, so schools, but also non-school entities can stock epinephrine to be used in case of an allergy emergency, in case of anaphylaxis. So it's interesting to talk through these. And what struck me is that so many panelists were concerned that the general population was not going to be easily educated on how to use an auto injector. And I I took a step back because at first I was surprised by this because auto injectors are fairly easy to use, even the ones that are not as user-friendly, right? They're still like fairly easy to use. Like, is there still a risk of injecting your thumb? Yes, there is. Um so, but I I was I was kind of confused. And I think some of this, because like why people are teachable. I think some of this comes back to trusting the patients, trusting people. And just because a parent is not a medical provider doesn't mean that they can't use a device. Um, and not that people said that, but but they seemed very hung up on could lay persons be easily trained on how to use a device? And where where the caveat to all this is, and what I mentioned earlier about sort of there's this new um, there's this new potential approval, like it's from the FDA. So I said there's over-the-counter drugs and there's prescription drugs, but now with over-the-counter, um, I want to make sure I say this right. Now with over the counter, there is a caveat, kind of an extra step. So that basically the FDA could allow more drugs to be over the counter instead of by prescription, which would improve access, but it would require an extra step. And so what that is is this thing called an acne, additional consideration for non-prescription use. Is it? Is that acnew? Or is it needed for use? Yeah, I guess additional consideration for non-prescription use. Or additional condition for non-prescription use. Yes, there we go. Basically, and here I'm on the FDA website. ACNU stands for additional condition for non-prescription use. Consumers must successfully complete an extra step to see if the drug is right for them before buying or using a non-prescription drug with an ACNU. This extra step makes sure that consumers can correctly choose and or use the right drug product on their own without first consulting a healthcare professional. An example of an extra step could be a questionnaire to determine if the drug is right for you. Um, so basically, uh a non-prescription drug, and this is on that same page on the FDA. This is a good page. Um, FDA regulates non-prescription drugs to ensure they're safe and effective, and that they're available to consumers without a prescription and can be safely and effectively used without the supervision of a healthcare provider. Um, and so non-prescription drugs include drugs for allergies, pain, fever, many more things. But basically, the difference between a non-prescription and a prescription drug, or an over-the-counter slash non-prescription and a prescription drug, is that really an over-the-counter drug is a drug that can be used really without engaging a healthcare provider. Um, kind it's kind of like we know, okay, well, if I have a fever, then I can take Tylenol, but I don't know how to take Tylenol. I have to read the back of the bottle, right? Um and so the idea that now the FDA is has this newer approach. I love it. I love it, I love it, I love it. Because people need access to medications and because the general population is not stupid. We have some of the smartest people in this country. And I see over and over again how we think that people are not sophisticated because they can't, because of X, Y, and Z, whatever. I mean, how many times do we see we're we're academicians or you know, they're in their ivory tower, and they're like, oh, these these people couldn't possibly understand how how to do this? We we have very, very smart people in our country and and across the globe. And really, auto injectors are pretty darn easy to use. Can there still be adverse effects? Yes. Do you need to know how to use it? Yes. Do you need to know when to use it? Yes, you do need to know when to use it. Absolutely. So is there some sort of education that someone needs before they can really accurate, like correctly use a device, not use it when you don't need to use it, use it when you do need to use it and use it properly? Well, yes, you do. Yes, there does need to be that. But is it doable? Of course it's doable, of course it's doable. And I think it's really doable with this FDA condition, this non-prescription judge product with an additional condition for non-prescription use. Now, what is that additional condition going to be? I have no idea. Um, but if you're from the FDA and if you're listening, then I'm happy to assist with it. And why I'm so passionate about this is because for years now, I have seen thousands of non-medical people, sometimes people who may not have even completed high school, who primarily are working in early childcare centers, are caregivers. They're called to take care of our little ones. They're not doctors, they're not nurses, they might not even have a degree. Like I said, they might not have even gone finished high school. But they're absolutely capable of recognizing an allergic reaction and treating it. They're capable of learning all of that. I've seen that because through code ANA, we have done that for years. Thousands, thousands. Early childcare providers have learned how to properly use an epinephrine auto injector. And I get emails saying thank you for education, or email because they've been you, the devices have been used and the child's been okay. All the stock epinephrine that we prescribe, um, I say we, me, my allergist colleagues, um, we prescribe it because it works. We prescribe it because it's needed. And just like an AED is needed immediately when somebody is having a heart attack or sudden cardiac arrest, right? Epinephrine is needed immediately to shut down the allergy reaction. And why it's needed immediately, and why antihistamines are not first line, is because antihistamines just address the histamine part of it. They do not address the stuff that is going to kill somebody from anaphylaxis. Um, so I heard somebody say once that antihistamines will help you not die as you itch, or will help you not itch as you die. There we go. Antihistamines will help you not itch as you die from anaphylaxis. I try not to use that type of language. Um, it's a little bit negative. I try to keep it positive, right? But antihistamines won't fix everything. And when we're talking about bronchoconstriction, meaning the airways are tightening up, someone can't breathe because the allergy cells are degranulating, mast cell degranulation is occurring, and those bronchoconstrictors go into the lungs, tightening up the lungs, not good. Epinephrine reverses that blood vessels opening up, drop in blood pressure, not good. Epinephrine reverses that, but epinephrine also stabilizes the mast cells to stop the reaction. Does epinephrine do anything that would really make somebody want to use it to abuse it? No. No. And there's negative, like you, it's a shot. It kind of hurts, right? But you're you're not just gonna like keep giving it to yourself. I know, I know. Drugs can be injected, IV, blah, blah, blah. Yes, I know. But epinephrine is not an opiate, epinephrine is not a narcotic, epinephrine is not a controlled substance. It's controlled in that it's prescrip it's a prescription, someone needs a prescription for it, but it's not controlled like a pain medication or anything else. So it is, it's not one of those habit-forming medications that we need to worry about. And if we're thinking about precedent and we're thinking that, well, let's look at some of the other medications that are available over the counter. Tylenol, tylenol is very dangerous. If you overdose on Tylenol, if you accidentally instead of pouring like 0.5 mls, you do 5 mls. Like that is a big overdose of Tylenol, depending on on your age, depending on your weight, especially in children. I can't tell you. And look, I've been dosing Tylenol for a long time for children. I'm a board certif, or a board-certified pediatrician here, um, an allergist, right, and internist, but dosing Tylenol, even in my own children, in the middle of the night, making sure I know their weight and making sure I'm not giving them too much, because I've seen the ill effects of Tylenol overdose. And it is very bad for your liver. It absolutely can cause liver failure, it absolutely can cause death. There is no dialysis for liver failure. Liver failure makes you very sick. So, all this to say, now, do I think Tylenol shouldn't be available? Over the counter? No, it's fine. It can be available. Have the directions on it. How to use it, right? Follow directions. Follow directions. But that's my point is the general public can follow directions, especially if directions are written well, especially if there's little pictures. And and at this at this panel, they even had like an example of something they were considering for an ACNU and had like this little diagram. And it was great. It was great. Anybody could follow it. I'm so off script right now. I don't even know where my script is. Script outline. Outline is an outline. Okay. Okay. So what was the panel actually about? I talked about that. Access to epinephrine. Your seat at the table, what you brought, me, what did I bring? Well, um, I brought a lot of information in here advocating for you out there, um, and really saying how how difficult it can be for patients to get their medication. Because did you know that if you have EpiPen on your prescription, on your uh like prescription benefits for your health insurance, and I only prescribe you AVQ and you take it to CVS, well, they can't, those are different devices. They're not interchangeable devices. And so they might tell you, oh, well, well, this isn't on your insurance plan, it's gonna be$800. And you're like, oh my gosh, I'm not gonna pay$800 for this. And it it takes a lot of work on the step of on for the pharmacist to try all the other different auto injectors and and the nasal epi to see how much which one would cost. And then trying to get extra devices, right? Because a device should be a two-pack of devices should be with a child who has a food allergy, an anaphylactic food allergy, IgE mediated food allergy, right? F pies, EOE, you don't need epi for those. Doesn't treat it, right? Doesn't treat the reaction. Anaphylactic, IgE mediated food allergy, that's what we're talking about here. So it needs to be available to them at all times. That means if it's a baby, it needs to be with the diaper bag, right? If it's a kiddo, it needs to be that kiddo needs to be learning, depending on their age, um, uh to self-carry it, how to self-carry it. And there always needs to be backup. So I have seen before, so this was a few years ago, where we had to work with a school system because they were not permitting a 10, 11, 12-year-old-ish honor student to self-carry the epinephrine. And then they were saying, okay, well, if you do, then we're not going to help you use it. Like people. Like, I understand people get concerned about liability. I completely understand that. But you will be more liable if you choose not to be prepared for potential medical emergency, especially one that can potentially impact millions of children. Millions of children have food allergies. Millions have anaphylactic food allergies. Depending on what study you read, it might be 8%, it might be 5%, whatever. But it is millions. And so we can't say, oh, well, we're just not going to do anything. We're just, we're not going to have Epi. We don't want to be at risk if there's some sort of, you know, I use it and I didn't know, I didn't really need to. When you actually look, and I read these laws all the time because I have to if so I read the Epi laws very, very often, because very, very often a school or non-school entity is reaching out to me from some different state asking how can they get it? And if I'm not licensed, how can it get epi? And if I'm not licensed in that state, I cannot prescribe it because healthcare is practice where the patient is located or the entity in this case is located, not where the doctor is located. So I can't just like prescribe for everybody in the U.S. unless I'm licensed in every state in the US. And I'm not. So then I look at our network or Cody and a network of allergists who prescribe. If we don't have somebody in that state, then I go down my iPhone and I ask if if I find anybody that I know. Um, you know, I stay very engaged with American Academy of Allergy, American College. Like I I love my allergy colleagues. I so I stay engaged with them. We text, like different cases, all that stuff too, right? Um especially fast OIT, the the big OIT group, international, amazing people, amazing people, collaborative people, wanting to help. Allergists want to help. Other dollar other doctors want to help, they want to prescribe, but they also want to know that this good deed will not be punished, right? And so the best thing I can do is just lead with, hey, we need some help with this. And by the way, this is what your state law says, and you're indemnified, and the entity is indemnified, and the person using it is indemnified. Um, pinning you use it properly. If you use it as a weapon, no, you're not indemnified, but don't use it as a weapon. I mean, I would argue a pencil is more dangerous as a weapon than an epinephrine auto injector. See, I am I am an advocate for this. Um what gave me hope is that there is on the brink this way that more people could just go to the pharmacy. There'd be different epinephrine auto injectors and nasal, whatever, different the film is coming out soon, right? The the the mouth sublingual, different ways to to administer epinephrine, and that you would just be able to go and look at your options, price transparency, what is that, right? That would be nice. Price transparency, pick the one you want and get it. And historically, look, I can't speak for drug companies, uh, right? This is that that whole thing is madness. But historically, when a drug goes over the counter, it does become less expensive. Now, wouldn't that be nice? Now, what would not be nice is if it went over the counter and then suddenly the health insurance was like, well, it's over the counter, so we're not going to pay anything for it. So where you may have been paying with$25 KoFay, now you're paying$99 or whatever it is. Who knows, right? That is a whole different discussion. Oh my goodness, health insurance situations. Okay, so what still concerns me is that those types of things. Um it it it does concern me just from like taking, you know, a step back in the 45,000-foot view of how I I think sometimes we as doctors don't give enough credit to our families. And it's important, especially as people get higher up in positions where they're more removed from that direct in the weeds patient care, that they remember that especially parents of kids with food allergies. I mean, these are some of the brightest families, parents that I've worked with. They're so engaged with what's going on with their kiddo and trying to really stay on the brink of what's coming out. Not all families. Some families want to more kind of like sit back and kind of like sweep it under the rug and not think about it. But a lot of families want to be very informed. And absolutely for lay persons as well, when we're thinking about is an epinephrine auto injector or the epinephrine nasal, is that something that people reasonably could learn how to use with an acne, with seeing a little diagram of if this, then that. Um, yes, that gives me hope. So I'm gonna wrap this up. Um, I have opined enough, and I opine on the um on the panel too, and you can actually go and listen to it. I'm in the second panel, but I would I would listen to it all. Um, I also thought really I also thought really interesting, my computer's making noises, um, is the way the FDA was explaining some of this approval process. It's fascinating. Um, yeah, so that's the podcast. Again, if you're not on the newsletter, go join it. Go to foodallergyandyourkiddo.com. And you're also able to submit to me the topics you want. I have some really great topics lined up, especially some that I've been seeing on Facebook lately. So I'll leave you with that. God bless you. God bless your family. Thanks for tuning in.

SPEAKER_00:

Thanks so much for tuning in. Remember, I'm an allergist, but I'm not your allergist. So talk with your allergist about what you learned today. Like, subscribe, share this with your friends, and go to foodallergy in your kiddo.com where you can join our newsletter. God bless you, and God bless your family.