Statement by Sung Poblete, RN, PhD, CEO of FARE, regarding the frustration felt by the food allergy community after FDA requests additional information and testing before approving neffy®, a needle-free epinephrine alternative
“As one of the more than 33 million Americans with life-threatening food allergies, I am frustrated by the FDA’s decision today. For 36 years, the food allergy community’s only treatment option has been to forcefully insert a needle from an epinephrine auto-injector into the thigh of the patient.
“Just four months ago at the FDA’s Advisory Committee meeting, neffy®, a needle-free epinephrine delivery device, was overwhelmingly approved by the Advisory Committee for both children (age 6 and above) and adults. Our community believed this innovation would finally come to the more than 10 percent of Americans with life-threatening food allergies, but instead, the FDA will force us to wait even longer.
“For all of the parents, caregivers, teen-agers, and children who carry, use, or rely on epinephrine auto-injectors to treat themselves or their loved ones, FARE is committed to doing everything possible to ensure you have a needle-free treatment option as soon as possible.”
FARE (Food Allergy Research & Education) is the nation’s leading non-profit engaged in food allergy advocacy as well as the largest private funder of food allergy research. FARE’s innovative education, advocacy and research initiatives transform the future of food allergy through new and improved treatments and prevention strategies, effective policies and legislation, and novel approaches to managing the disease. To learn more, visit: foodallergy.org.