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FDA Announces Public Workshop on Improving Access to Epinephrine
Seeking Input on Approaches to Reduce Anaphylaxis-Related Deaths
The Duke-Margolis Institute for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration (FDA), are holding a hybrid public workshop, "Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine", on December 16, 2025. The workshop will examine potential barriers to epinephrine accessibility and use and will explore potential regulatory and policy solutions to improve availability of this life-saving medication for anaphylaxis treatment.
Anaphylaxis is a severe, rapidly progressive allergic reaction with a lifetime prevalence of up to 5 percent in the United States, resulting in approximately 200 deaths annually. This life-threatening reaction can occur within minutes of exposure to common allergens, including foods, medications, and insect stings. Epinephrine is the only effective first-line treatment for anaphylaxis.
However, potential barriers limit access to epinephrine, including: patients not having epinephrine available during emergencies; knowledge gaps and fear preventing proper use; institutional barriers in schools, workplaces, and public venues; varying state laws regarding Good Samaritan protections; economic obstacles; and geographic disparities, especially in rural communities with limited health care infrastructure.
The workshop will feature presentations, panel discussions, and public comment sessions. Registration is free and available online until December 16.
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