Early this month, the Food Allergy Collaborative (of which AllergyStrong/AllergyShmallergy is a founding member) and its generous sponsors hosted the Externally-Led Patient Focused Drug Development (PFDD) meeting for Food Allergy. This impactful event was held for the benefit of the U.S. Food & Drug Administration (FDA) who governs therapies for this condition and sets labeling policy.
The purpose of a PFDD meeting is to present the patient’s experience and perspective to the FDA so that they consider the needs and priorities of our community as they approve new treatment and set regulations. The PFDD for Food Allergy meeting enlightened the FDA about the challenges and hardships faced by patients of all ages and backgrounds, the types of treatments and therapies we would like to see approved, as well as the risks we are willing to face vis-a-vis treatment options.
We heard from patients from all over the country who voiced their experiences with food allergy. Throughout the meeting, some themes echoed over and over again:
- The need for more accurate and informative diagnostics that are less invasive;
- The need for accessible, affordable food that is contains easy to evaluate, accurate labeling;
- The need for less invasive, easy to carry emergency medication; and
- The need for long-lasting therapies that treat allergies beyond the peanut.
Another topic that was mentioned again and again was a priority to find and approve treatments for the 26 million adults living with food allergy. As one participant stated, “…current treatment is oriented towards children. Those children DO grow up.” Another panelist described her adult on-set food allergies with chilling effect. “One day, I was eating this food without any issues. The next day… it nearly took my life.”
The Food Allergy Collaborative captured the broadest experience possible to represent the incredible diversity of patients and their individual journeys with food allergy. This included patients of different socioeconomic backgrounds as well as those who live in different communities across the country. We had representation from young and older patients, those with and without multiple food allergies, within and outside the Top 9 most common allergens, with and without related conditions (like eczema, asthma and EoE), those who have undergone treatment and those who have not.
The Food Allergy Collaborative is looking for more voices and additional perspectives using the link below. Comments will be accepted for up to 30 days (October 8, 2021) for inclusion in the Voice of the Patient report. Patients impacted by food allergy are asked to think about:
- the burden of food allergies;
- their diagnosis journey and the challenges associated with diagnosis and oral food challenges;
- the challenges with avoidance and finding safe food;
- the challenges and experiences with epinephrine auto-injectors;
- their experience with treatment and clinical trials (how did it improve – or not – their lives? If they dropped out, why? What would they like to see in a treatment option?);
- Acceptable/unacceptable risks for food allergy treatment; and
- Desired goals for food allergy treatment/management.
We want to hear from you! Please submit your comments here: PFDD Patient Comments.
With this portion of the PFDD process behind us, the Food Allergy Collaborative is focused on the Voice of the Patient report. This report – to be published in Spring 2022 – will combine relevant research and survey data with the testimonies from the PFDD meeting and digital submissions. This will offer the FDA the fullest picture of patient experiences possible, which will assist them as they review products which meet our communities’ needs. The Food Allergy Collaborative has high hopes that our patients’ testimonies and the information that follows in our Voice of the Patient report will serve as an excellent resource for the FDA and other agencies as they evaluate treatments and consider policy for patients with food allergies.