As a food allergy advocate and concerned parent of a child with severe food allergies, I am writing this petition to urge the Food and Drug Administration (FDA) to approve nasal epinephrine as an alternative delivery mode for emergency anaphylaxis treatment.

Anaphylaxis is a life-threatening reaction to a food, drug, insect venom, or environmental substance. Epinephrine is the only treatment that can halt and reverse the progression of anaphylaxis, but it must be administered promptly following onset to have effect.

The majority of anaphylactic deaths are due to delays in administering the drug, and one primary reason for that delay is fear of the needle that current emergency epinephrine devices employ.

Today's standard — the epinephrine auto-injector — requires the patient or caregiver to stab the patient in the outer thigh, a daunting prospect, especially for children. I have heard stories of children hiding their reactions for fear of the subsequent jab, which has the potential to result in tragedy.

Even as a food allergy advocate, I am embarrassed to say that we have delayed administering epinephrine, viewing the needle as a high bar to clear despite knowing the potential consequences.

Nasal delivery of epinephrine eliminates this fear and would result in more prompt administration of the drug when anaphylaxis is first suspected. Furthermore, clinical studies have shown that nasal administration of epinephrine delivers the drug as effectively as auto-injectors and intramuscular injections.

The FDA's own advisory panel voted 17-5 to approve a nasal epinephrine candidate for children and 16-6 for adults in May of 2023, but the agency changed direction and denied approval of the device in September. We, the allergic community, desperately need this mode of delivery, which will eliminate hesitation, lead to better outcomes, and save lives.

I urge the FDA to consider the importance of this issue and take swift action. The agency must ensure that fear of the needle and the hesitation it causes do not put more lives in jeopardy.

Thank you for your attention to this matter.

Sincerely,

Dave Bloom
CEO, SnackSafely.com