Voice of the patient brochure cover

Download a copy of the “Voice of the Patient Report” from the PFDD meeting on food allergy. The report summarizes the findings from the September 9, 2021 meeting with FDA. It includes written comments from patients and caregivers.

The report was produced by the Food Allergy Collaborative.

Bethesda, Maryland (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 (PFDD) meeting held Sept. 9. The PFDD meeting 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 and 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 of 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 and 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 know the severity of an allergic anaphylactic reaction due to cross contact or ingestion of food given.”

PHoto of PFDD conference with speaker, video screens, and socially distancing audience.

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 $4.00. The non-dairy substitute that was most effective for Catherine cost just over $15.00 a gallon. This became very difficult for our family to maintain. The markup on gluten-free flour is over 1,000% 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, 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, 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 and long-term management of food allergies. We need a clearer regulatory path and implore the FDA to expedite the review and 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 20 life-threatening reactions. We implore the FDA to hear our cries and respect our desire to live a life free of fear from food.”

Photo of the PFDD meeting with video and audience. The seats are spaced for social distancing

Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, concluded the day’s PFDD meeting by sharing that two of his now three grown sons had food allergies. He 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. It 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 PFDD held by the FDA.

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.

Remarks from Tonya Winders at the Externally-led PFDD Food Allergy Meeting

Tonya Winders presenting to the FDA about Food Allergies

Tonya Winders, President and CEO
Allergy & Asthma Network

Today we have been invited into the hearts and lives of so many families living with food allergy. The food allergy mom club is one that I never wished I would be a part of. The food allergy journey and struggles that we’ve heard today are ones that touch me in the very deepest part of my heart and my soul – not only for my daughter Karson but also for the generations to come.

It is because of the stories we have heard today – the patient journeys, the unmet needs – that I stand before you. I want to recap what we’ve heard this afternoon and really throughout the entire day. There are significant unmet needs in food allergy.

First, there are unmet needs in prevention. We heard from Lisa, Emily and others about the need for better labeling on the front of the package with simple language, pictures, images that could be understood by people of any language. We also need better access to foods as medicine.

Secondly, we have unmet needs in diagnosis. Erin and Amelia spoke so eloquently about the need for diagnostic tools that have greater sensitivity and specificity in order to reduce overdiagnosis, misdiagnosis and underdiagnosis in our community.

Next, we have unmet needs in treatment. Dawn, Maeve and others charged us with the question, ‘What about beyond peanut?’ What about the community beyond the 4-17 year olds? Yes, we are so excited to have an FDA-approved option for that community, but what about the rest of us? We need to target the whole person, not just the symptoms. We need a clearer regulatory path and expedited review of innovative treatments to address the unmet needs. OIT, EPIT, SLIT, toothpaste – who knows what these solutions will be? But we implore the FDA to expedite the review and regulatory process to address them.

We also have unmet needs in long-term management. We heard from Priscilla about the importance of anaphylaxis awareness and preparedness, but that may not be enough. Certainly we need new routes of administration for epinephrine that are affordable, accessible, convenient, cost-efficient, and remove the fear of needles that over 30% of Americans currently have. I love the question, ‘Could there be an easier way?’ Certainly the answer is yes.

Emily charged us with addressing diversity and inclusion and the unmet needs in research and development. And as we stood here today, I could not get the words out of my head, that no one should be forced to live in fear of the more than 20 life-threatening allergic reactions like Maeve. No one should be forced to deal with the loss of a child, like Elijah, like Thomas and his family deal with every single day. As a mom and an advocate in the food allergy space, I want to thank each and every patient and caregiver who has come forth today to share their story.

I want to again implore the FDA to hear the cries of the unmet needs of the more than 30 million Americans who simply desire to live life free of fear from food. Thank you.