December 16, 2025
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Sessions
About
Anaphylaxis is a severe, progressive allergic reaction that can be fatal if not promptly treated with epinephrine. Failure to treat anaphylaxis within minutes can lead to airway obstruction, shock and multiorgan failure. Despite being the only effective first-line treatment approved by the Food and Drug Administration (FDA), barriers may limit access to and use of epinephrine. For example, patients and caregivers may experience challenges in determining whether and how to administer epinephrine to treat an anaphylactic reaction. Institutional barriers may also inhibit access to and use of epinephrine in community settings, such as schools, workplaces, restaurants and other public venues. Additionally, there are potential procedural barriers to obtain authorization from a health care professional before carrying epinephrine. These barriers may be magnified in communities with limited health care infrastructure, and by the cost of epinephrine products. While Federal and state legislation has sought to expand access to epinephrine by directly addressing barriers to use, additional policy and regulatory solutions may be needed to help ensure life-saving treatment for anaphylaxis is readily available when needed in an emergency to improve anaphylaxis outcomes.
This workshop on December 16, 2025, 2025 initiated a discussion on expanding epinephrine accessibility and use, including in community settings, to reduce anaphylaxis-related morbidity and mortality. Prospective approaches intended to improve anaphylaxis outcomes include but are not limited to expanding training on use, enhancing civil liability protections for administrators of epinephrine, incentivizing availability in public spaces, and considering development of epinephrine for nonprescription use.
Topics
- Allergic diseases, anaphylaxis, and treatment of anaphylaxis in the community setting
- Regulatory pathways for epinephrine products, including considerations for prescription and nonprescription development
- Current accessibility to epinephrine for treating anaphylaxis
- Opportunity to enhance access to and use of epinephrine translational modeling and digital twins