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.”