Wednesday was quite the day. To the general public, it was a typical fall day with fall leaves blowing by, work to be completed, kids to be picked up and dinner to be cooked. For many of us in the food allergy world, October 26th, 2016 signaled a special moment in time. One that ignites the continued story of a lifetime of work and commitment to innovation. I had the honor of relishing in this occasion during a phone call with Evan and Eric Edwards, co-creators of the Auvi-Q epinephrine auto-injector and co-founders of kaléo Pharma. The announcement of the future (2017) return of the Auvi-Q epinephrine auto-injector had the internet lit up. All major news outlets carried the breaking news story.
Our brief conversation was simply emotional.
Imagine the path of the last year: the Auvi-Q was growing in popularity with teens and others managing life-threatening food allergies. Then, out-of-the-blue, the device is recalled by Sanofi (distributor at the time) and chaos ensues. Our community worked feverishly to inform each other of the recall and the need to find replacements quickly, while some panicked over finding funds to make the purchase. Those first few days of the recall were flat out stressful. Losing a cherished life-saving device is not easy to swallow.
Eventually refunds were issued, patients were heart broken and upset as to why the recall occurred. Sanofi gave the rights back to kaleo and the Auvi-Q was back in the Edward’s Brother’s court. Trust was broken and teenagers started refusing to carry the larger sized EpiPen®. To add insult to injury, the continued high cost of EpiPen® reached a breaking point and Mylan was under scrutiny. Daily, the headlines challenged Mylan’s motives while Congress stepped into investigate. Frustration remained high in the allergy world.
For me personally, I wanted kaléo to finish what they started as teenagers: to provide a life-saving epinephrine device to meet the needs of a changing society. I knew of far too many teenagers who were devastated to loose their compact size epinephrine auto-injector. Some even dangerously hanging onto recalled devices.
Wednesday’s news is symbolic of hope.
After speaking to the brothers, I realized they have been listening closely to the food allergy community. In their interview with Allergic Living Magazine’s editor Gwen Smith, “Auvi-Q Makers Announce Relaunch of “Talking” Auto-injector”, Eric Edwards, shared that, “it’s personal”. This was clearly evident in our conversation, I could hear it in both brothers’ voices. We were no longer discussing big business, we were chatting about saving lives.
They seemed to have moved beyond pharmaceutical industry entrepreneurs to two men picking up what they started, with a commitment to moving even farther. The video below explains how they tackled and remedied safety issues using technology and innovation. kaleo has also published a Manufacturing Report, which directly addresses the recall and why the Auvi-Q is considered safe. When I asked about safety, they reminded me that they are patients and parents of food allergic children and they would never put their children or mine at risk. Yup, they rely on this product as much as we do to keep loved ones alive. They talked about how they felt when the recall occurred and going to their children’s school to replace their Auvi-Q’s. It was dark day needless-to-say.
Now that safety is no longer an issue, it is evident that there is much work to be done in terms of putting all the pieces together so that the Auvi-Q is affordable, accessible and available. The brothers discussed the arduous work of speaking to insurers, pharmacy benefit managers, etc. This is a very complicated heath care system and no easy task. I would not want to walk in their shoes, but I am grateful that they have chosen to continue to fight the good fight and understand our need to affordable options. I felt their honest and raw emotions when they spoke about the food allergy community and their gratitude for the work of advocates, parents and patients.
I appreciated their transparency and honesty in saying they are working to solve the problems that create barriers (costs, no insurance coverage, etc.) so that people can have access the Auvi-Q, but don’t have the answers yet. Often companies don’t want to admit they don’t have the answers yet, so I appreciated their answer. kaléo also launched a customer service number today so consumers can have access to as much as data as possible: 1-877-30-AUVIQ. Initiating change is simply taking that first step and acknowledging what is broken and not working.
I agree, it is personal. Eric and Evan Edwards have a life mission to complete and they are hell bend on getting there.
Disclaimer: My feeling emotional is just how I am feeling today. I hated the day the Auvi-Q was recalled and I remember frantically posting, calling and reaching out to our community to help sound the alarm. I was heart broken when my son headed to college without the Auvi-Q in his pocket. I am thrilled for competition. I am thrilled that the Edwards brothers did not walk the other way, but took on the commitment to make the Auvi-Q safe and reliable. I am hopeful affordable pricing and access is heading our way. kaléo, nor the Edwards brothers have paid or asked me to write about this big news. Nor was I was asked to be emotional. This is just one big beautiful deal in my world and I wanted to share.