Yesterday, I had the extraordinary honor of visiting the Food and Drug Administration (FDA) to urge them to include Narcolepsy in the ground-breaking Patient-Focused Drug Development initiative.
I was #19 to sign up on the disease nomination speaker list, even though I arrived 15 minutes before registration technically opened. The large conference room quickly filled to capacity, along with the overflow room nearby. Business suits, laptops, serious faces. My heart pounded.
Patrick Frey, Director of the Office of Planning and Analysis at FDA kicked things off welcoming everyone and reporting that so far, 438 comments have been collected on the public docket. He emphasized, “A written comment is JUST AS valuable as speaking here today.”
Next, Janet Woodcock, the Director of the Center for Drug Evaluation and Research at FDA gave opening remarks. What an honor to have Dr. Woodcock with us! We also heard from Theresa Mullin, Director of the Office of Planning and Information, who is spear-heading this initiative, along with various division directors at FDA.
The disease nomination speakers portion began around 10:15 a.m. My nerves ebbed and flowed as patients and patient representatives delivered
passionate pleas to the FDA. I learned about conditions I had never heard of. My eyes welled with tears when patients with ALS shared their stories.
When my turn arrived around 11 a.m., I stood at the microphone at the center of the jam-packed room and delivered my remarks with calm confidence. I looked directly into the eyes of the FDA representative panel. My two minutes flew by!
In conclusion, I’ve spoken in many venues about narcolepsy at this point and I can easily tell when someone isn’t listening. I am thrilled to report FDA was LISTENING. They were engaged, heart-felt, and human.
FDA is tasked with the impossible here — choosing only 20 disease areas for the first stage of this patient-focused program. I am humbled by their bravery in taking on the task. Please join me in thanking them for LISTENING and urging them to take on narcolepsy! Comments are due Nov 1.
For updated posts about the FDA Initiative, click here.