Food Allergy Patients and Parents Report Challenges of Managing Disease to FDA
At Externally-led Patient-Focused Drug Development Meeting, More Than 40 Advocates Ask for Better Diagnosis, More Treatments, and Diversity and Inclusion During Testing
Bethesda, MD. (Sept. 10, 2021) – The U.S. Food and Drug Administration (FDA) heard from more than 40 food allergy patients and caretakers describing the challenges of living with food allergies as part of a day-long hybrid Externally-led Patient Focused Drug Development (EL-PFDD) meeting held Sept. 9. The EL-PFDD was the result of a nearly two-year project of the Food Allergy Collaborative, a coalition of eight food allergy organizations, those living with food allergies, industry partners, and the FDA.
In opening remarks, FARE President & CEO Lisa Gable, said, “Nimble partnerships like the Food Allergy Collaborative and our work with FDA to elevate the patient's voice are critical to accelerating research and development and the approval of therapeutic products that meet the needs our community. These efforts are critical as food allergies are life-threatening and can wreak havoc physically, emotionally, and economically for 32 million Americans.”
Thomas Silvera, Co-Founder/President & CEO of the Elijah-Alavi Foundation, participated in the first panel about the symptoms and daily impacts of food allergy, shared that he, his wife, and son all have food allergies and said, “Being a family with multiple food allergies had required us to change up our eating habits and how we manage navigating outside our home as well. This has created so much anxiety because we really didn’t trust anyone with our children preparing their meals, whether it was family, friends or restaurant. We live in a constant fear about the ‘what ifs’ because we knew the severity of an allergic anaphylactic reaction can caused due to cross contact or ingestion of food given.”
At the end of the first panel, Eleanor Garrow-Holding, CEO of the Food Allergy & Anaphylaxis Connection Team (FAACT), summarized the concerns of patients and their families. “The impact that food allergies have on families’ physical and mental health cannot be overstated. Poor nutrition is a problem due to limited ‘safe’ food options. Labeling laws leave a lot of gray area around what may or may not be in packaged foods. Epinephrine auto-injectors – the only medication that can stop a life-threatening allergic reaction – can cost hundreds of dollars, even with health insurance. Families need more, affordable epinephrine delivery options. Oral food challenges, the gold standard for diagnosing food allergy, can be physically and emotionally traumatizing for patients. We look forward to working with the FDA and industry participants to provide more therapies and diagnostics to lessen the burdens food allergies cause for families across the country.”
Patients and caregivers in the second PFDD panel highlighted for the FDA their perspectives on prevention and treatments for food allergies. Emily Brown, a food allergy parent and the President of the Food Equality Initiative, discussed the high cost of protecting her daughters saying, “The burden of food avoidance for our families is steep. When my daughter, Catherine, was first diagnosed, we did our best to manage the escalating cost of our grocery bill. The average cost of a gallon of milk in Kansas City is about $4. The nondairy substitute that was most effective for Catherine cost just over $15 a gallon. This became very difficult for our family to maintain. The mark up on gluten free flour is over 1,000 percent more than all-purpose flour. I could no longer afford our weekly pancake breakfasts. I now only made pancakes for holidays and birthdays.”
While Erin Malawer, the Executive Director of AllergyStrong, and a food allergy parent, shared that she was concerned that there were no FDA-approved treatments for adults. “Current therapies are heavily based in prevention and reversal of symptoms in young patients. As my son nears his 17th birthday, he is also nearing the end of a window for effective treatment. Without treatment, my son's age turns his food allergies into a life sentence. We need options for the 26 million adults living with food allergies. It’s time to make food allergy diagnostics more effective and emergency treatment less invasive. We need approved therapies that are wider-reaching and longer lasting. Alongside our industry partners, the FDA can make a difference for the 32 million Americans and hundreds of millions of patients worldwide who are handicapped by this burdensome and life-threatening condition.”
At the end of the second panel, Tonya Winders, the President and CEO of the Allergy and Asthma Network, said, "The food allergy challenges heard today moved me deep in my heart and soul. Significant unmet needs exist in prevention, diagnosis, treatment & long-term management of food allergies. We need a clearer regulatory path & implore the FDA to expedite the review & approval process to address these unmet needs. As we heard today, no one should be forced to live in fear of losing a child or experiencing more than twenty life-threatening reactions. We implore the FDA to hear our cries & respect our desire to live a life free of fear from food."
Kenneth Mendez, the President and CEO of the Asthma and Allergy Foundation of America, concluded the day’s EL-PFDD meeting by sharing that two of his now three grown sons had food allergies and stated, “This meeting reminds me of when my sons were infants and toddlers and our family was experiencing living with food allergies. Hearing from patients and families at today’s meeting signals that there’s been slow progress since my family experienced this 27 years ago. I hope the team from the FDA leaves the meeting with an understanding of the immediate needs of the food allergy community: more FDA-approved therapies that eliminate the risk of accidental food allergen exposure, better science-based labeling, and improved access to affordable life-saving epinephrine auto injectors. I hope this meeting inspires the FDA to have a greater sense of urgency and also understand that there’s a disproportionate burden of food allergies on racial and ethnic minority populations.”
The food allergy community is encouraged to share their perspective on living with food allergies through the comments form, which can be found on the Food Allergy Collaborative website, www.foodallergycollaborative.org/pfdd and can be accessed for up to 30 days after the meeting date. The meeting materials, related research, and submitted comments will be part of a Voice of the Patient Report, available Spring 2022.
This event marked the 50th EL-PFDD held by the U.S. FDA.
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About the Food Allergy Collaborative
Launched in 2019, the Food Allergy Collaborative is an alliance of advocacy organizations, those living with food allergies, and industry partners who are uniting to advance effective, patient-centered initiatives in food allergy awareness, research and care.
For general inquiries, please call 703-485-6551.
FARE is the world’s leading non-governmental organization engaged in food allergy advocacy and the largest private funder of food allergy research. Our mission is to improve the quality of life and the health of individuals with food allergies, and to provide them hope through the promise of new treatments. FARE is transforming the future of food allergy through innovative initiatives that will lead to increased awareness, new and improved treatments and prevention strategies, effective policies and legislation and novel approaches to managing the disease. To learn more about FARE, visit our Living Teal™ YouTube channel, or www.foodallergy.org.