Food & Drug Administration
Erin Malawer, Executive Director, AllergyStrong
I was so honored to be chosen as a speaker at the US Food & Drug Administration’s (FDA) Allergenic Products Advisory Committee (APAC) meeting (September 13, 2019). The purpose of this groundbreaking hearing was for the APAC to have a discussion and make recommendations to the FDA on the safety and efficacy of Aimmune’s AR101 peanut allergy treatment at reducing the risk of severe allergic reaction (anaphylaxis) after accidental and unintended exposure in children and teens with peanut allergy.
Representatives of major food allergy non-profits, knowledgable doctors with deep experience with desensitization, experts in psychology, the underserved population, patient advocacy as well as affected families offered an honest and complete picture of the lives and challenges of living with food allergies to the APAC panel. Testimony focused on quality of life, psychosocial impact of food allergy, daily challenges, and unmet needs. Discussion also centered on medical guidance, patient choice in regards to risk/benefit of AR101, and education as it relates to AR101 therapy.
It is my hope that the committee approves this treatment.
Until now, food allergy families have had only one management option: avoidance. If the FDA approves AR101, it will standardize dosage, treatment protocol and, hopefully, increase its accessibility. AR101’s approval could pave the way for more treatment options down the road.
As of now, APAC is still debating and arriving at their decision. Stay tuned for an update.
Here is the testimony I gave today:
Executive Direction, AllergyStrong
Food allergies are a challenge that affect both the physical safety as well as mental health of patients and caregivers. Bringing AR101 (Palforzia) to market as a treatment option has the potential to greatly improve quality of life for these families.
What is the experience of having food allergies for patients? In the words of my 14 year old son, “it’s a second, full-time job.” And it starts the moment patients wake up beginning with:
The toothpaste they use to brush their teeth;
The laundry detergent they wash their clothes with; and
The lip balm I wear when I kiss my son goodnight.
And, then there’s the FOOD! Meals, snacks at school, the baseball stadium, the movie theater. Patients must be knowledgeable about ingredients; how and where food is prepared and processed; as well as how to communicate and educate others about their condition. The burden falls on families and caregivers to prepare safe food for holidays, school celebrations, birthday parties, field trips, and travel.
The thought and preparation is endless. Food allergies are always on our minds.
Anything misread, any small misstep could potentially endanger a patient’s life.
The solution we’ve been given to keep him safe is simple, but daunting: Avoid.
In order to do that effectively, each patient and their caregivers must understand both the seriousness of food allergies and the risks of cross-contamination. But, we also need to be intimately familiar with labeling laws and loopholes as well as manufacturing practices.
That keeps my child relatively safe at home. But what about when he – and millions of other allergic children – step outside and navigate the real world?
Avoidance is challenging – it relies on the understanding of others – who are less experienced – for our health and safety. Avoidance is cumbersome – labeling laws are incomplete, manufacturers aren’t always forthcoming and decision-making, even at its best, is difficult. Avoidance accepts food allergies and all the associated worry, guilt, and burden as a life sentence and – because we all make mistakes – it accepts reactions as an inevitable.
From an early age, my son understood these risks. He has lived under the stress and reality that the next meal could cost him his life.
At age 8, my son educated his own grandparents on what it’s like to live with food allergies. “Grandpa,” he said, “I can’t be careful 75 percent of the time. I need to be perfect 100 percent of the time.”
AR101 has the potential to change that. If only he could have undergone treatment to lessen that incredible emotional burden. AR101 (Palforzia) has the potential to make childhood easier for food allergy families.
Food allergic children and caregivers often struggle with anxiety, depression, and social isolation. Many children experience bullying at the hands of peers as well as adults.
In desperation, families are sometimes driven to turn to unregulated alternative treatments that leave them vulnerable and at risk. Allowing for well-studied, standardized, accessible food allergy treatment outlines an established course of action for those looking for help.
AR101 (Palforzia) would be life changing for patients. It offers much-needed hope for food allergic families; relieves mental strain on the patient as well as caregivers; allows room for inevitable error; and it dampens accidental exposure and threat of severe reactions.
It could specifically be transformative for patients in underserved communities where food allergy resources are often lacking, where emergency room visits are more common, and where reliance on those outside the food allergy community is necessary.
I’d like to end by saying, at the present time my own child is ineligible for this treatment. No matter what the outcome is today, he will continue to live under the specter of food allergies. But professionally, I must advocate for patients who lives can be improved by AR101 (Palforzia) and the possibility of leading a more normal life.
With this treatment, it may be possible for food allergy families to thrive and not merely survive.
FDA Review of Aimmune Peanut Therapy I was so honored to be chosen as a speaker at the US Food & Drug Administration's (FDA) Allergenic Products Advisory Committee (APAC) meeting (September 13, 2019).