Representing People with Narcolepsy at the FDA

by julie on October 26, 2012

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.

{ 17 comments… read them below or add one }

Stephanie Suttle October 26, 2012 at 4:38 pm

Thank you for not only being our voice and advocate but also for being our biggest source of inspiration and support!

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julie October 26, 2012 at 6:11 pm

Stephanie, your support means so much to me. Thank you from the bottom of my heart. 🙂 Julie

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Robin Feder October 26, 2012 at 4:55 pm

Proud to know that my comments and letter are among the 438 available to the FDA! Proud of you, Julie for being the voice for so many!

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julie October 26, 2012 at 6:10 pm

Thank you so much for sending in your comment, Robin!! Big smiles, Julie

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Sarah October 26, 2012 at 10:56 pm

Awesome Job, definitely one of the braver Narcoleptics!!! 😉
Sent in my letter, fingers crossed narcolepsy gets chosen!
Cheers.

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julie October 29, 2012 at 12:16 am

Sarah, Thank you so much for sending in your letter. I hope we get chosen too! Fingers crossed. Many thanks, Julie

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Kevin October 27, 2012 at 3:27 pm

Thank you for your dedication Julie. It was so refreshing to find your site recently, right in time to learn of the FDA initiative.
I have to add, from someone who has almost no hope left of ever living anything close to a normal life with this disease – much less being undersood, the positivity you exude is a rare and welcome change that actually brings a smile to my face. Hope you know how much you are appreciated.

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julie October 27, 2012 at 3:57 pm

Kevin, thank you so much for checking out my blog. I know narcolepsy can be so extremely tough but hang in there. Sending smiles and wakefulness your way, Julie

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Ashley October 29, 2012 at 12:19 am

Julie,
Thanks for representing! I submitted my letter today. My mom, aunt, and boyfriend are also submitting 🙂

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Alex Withrow October 29, 2012 at 2:49 pm

You’re such a tireless advocate for this condition, it is so very inspiring. Really glad to hear the FDA actually listened. I think that is extremely important, and I’m glad you mentioned it specifically.

Keep it up, Jules!

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julie October 29, 2012 at 10:51 pm

Thank you so much, Alex! Your support means the world to me.

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Karen October 30, 2012 at 3:49 am

Julie you are a great roll model. My daughter, Heather is almost 12 and was diagnosed Aug. 2009 N w/C. She has had a rough first few years. I first saw the article of you in the CVC magazine. I’m glad I found this site. I feel helpless most of the time to her, but I keep looking for more info. Thanks for being our voice for Narcolepsy. I submitted my comment to the FDA!

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julie October 30, 2012 at 10:15 am

Karen, thank you for your kind comment. I’m so sorry to hear your young daughter has narcolepsy with cataplexy. Your support of her experience is invaluable. I’m so glad you read my article in CVC’s Community Magazine and found my website too! Thanks for sending in your letter to the FDA. With gratitude, Julie

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Cindy November 1, 2012 at 9:51 pm

I submitted my letter! Just doing my part. Keep on keeping me informed. C

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julie November 1, 2012 at 10:16 pm

Thank you so much, Cindy! Big smiles, Julie

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Cheryl November 17, 2012 at 10:43 pm

Any idea which 20 diseases the FDA chose?

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julie November 18, 2012 at 1:51 pm

Hi Cheryl, there is no word from the FDA yet on the final disease areas chosen. I’ll be sure to send an update as soon as I hear. Thanks so much.

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