Statement by Sung Poblete, RN, PhD, and CEO of FARE, regarding FDA Advisory Committee action on a new nasal epinephrine delivery system

“Food Allergy Research & Education (FARE) commends the esteemed members of the Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) for taking the first step in making nasal epinephrine spray an innovative option for those facing anaphylactic emergencies. Epinephrine is a life-saving drug for more than 32 million Americans who have life threatening food allergies.

“Specifically, the committee discussed a new drug application of an epinephrine nasal spray for the proposed emergency treatment of allergic reactions including anaphylaxis. Following strongly positive votes, the PADAC recommended the approval of this new nasal epinephrine delivery system for both children and adults. The Committee pointed to the clear need for an innovative option for epinephrine delivery and responded to the 600+ comments on the FDA website and over 20 public comment speakers in favor of approval. Their recommendation now goes to the Center for Drug Evaluation and Research (CDER) at FDA for a final determination.

“Advances in innovation and technology benefit the food allergic by providing options for prevention and treatment of the disease and the consequences of food allergy. We are greatly encouraged and hopeful that the proposed nasal epinephrine spray is the first of many innovations that will help change the lives of those with food allergies.

“In addition, we want to thank the countless members of the food allergy community who spoke out on this life changing innovation. Support for new technologies and needle-free epinephrine options is a benefit to all who live their daily lives with the threat of a potentially fatal food allergic reaction.”

For Further Information: To read Dr. Poblete’s public comments from the May 11 FDA Advisory Committee meeting, click here.