Join me: Urge FDA to include Narcolepsy in new patient-focused initiative

by julie on October 23, 2012

The Food and Drug Administration (FDA) has nominated “narcolepsy” for a groundbreaking new patient-focused drug development initiative. Only 20 diseases will be chosen. Please join me in urging the FDA to select “narcolepsy” for this important effort. 
 
About the FDA Initiative:
“Narcolepsy” is one of 39 disease areas nominated for a new FDA initiative to better inform the FDA’s drug and biologics review process with input from patients who experience particular diseases or conditions. (Details here)
 
Only 20 disease areas will be chosen.Two weeks ago, I attended the preliminary planning meeting at the FDA and this Thursday, I will attend the packed in-person meeting to urge FDA to choose narcolepsy.  

I need your voices behind me, sent in via public comments. 
 
Your Voice Counts:
• The FDA is soliciting Public Comments to help choose the final 20
• People with narcolepsy, loved ones and caregivers are ALL encouraged to comment.
• You can comment anonymously or using your name. 
• Act now! The Nov. 1st deadline is quickly approaching.

Working with public policy experts, I’ve created this Submission Guide and Example Letter for the narcolepsy community.
 
The more comments, the greater our chances. Please take two minutes today to build a brighter future for narcolepsy tomorrow

With gratitude,
Julie

For updated posts about the FDA Initiative, click here.

{ 16 comments… read them below or add one }

Carol Mahlstedt October 24, 2012 at 2:00 pm

I STRONGLY urge the FDA to select Narcoplepsy for new “patient-focused” drug development initiatives. This disorder has a devastating impact on the academic, professional and relational lives of patients and their families. In otherwise healthy individuals, this disorder can completely destroy patients’ careers, relationships and their ability to function adaptively day-to-day.

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julie October 24, 2012 at 2:04 pm

Thank you, Carol, for supporting my efforts! This is a well-written statement. Let me know if you have any questions about the public comment submission process on regulations.gov website!

Sending wakefulness and many thanks your way, Julie

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Brianna October 24, 2012 at 2:59 pm

Please support this cause, for every child who is left with only one parent most of their life because the other parent is asleep or unable to get out of bed due to Narcolepsy. Also, for every child inflicted with Narcolepsy who can’t go out and play with their friends because they are too tired to go outside. People with Narcolepsy are having to sleep their lives away. Please help to give them their lives back.

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julie October 24, 2012 at 3:02 pm

Thank you, Brianna! We will fight hard for a brighter future. Cheers, Julie

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Julie October 24, 2012 at 3:04 pm

Julie,

The download submission guides and letter link is not working. Would like to forward you letter to all friends and family.

Thanks,
Lynne

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julie October 24, 2012 at 3:09 pm

Lynne, Thank you for this feedback. I *think* I’ve resolved the issue.

Please try: http://julieflygare.com/fda-letter/

Let me know if you continue to have issues with this!

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Jessica October 25, 2012 at 10:52 am

Julie-

Thank you for the submission guide and letter! I just wrote mine and submitted it. I hope that many others will do the same! I read through the public comments that were posted and there were none out of the thirty! Have you posted this to the Narcolepsy Network message boards? Maybe more people will see it there? I saw it on the main page, but I know that when I go to NN that I generally skip to the message boards pretty fast!

Thanks again!
– Jessica

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julie October 25, 2012 at 12:44 pm

Thank you so much, Jessica!! Please spread the word wherever you can. I’m sitting at FDA meeting waiting for it to start. I’ll report back afterwards. Cheers, Julie

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Jeanne Murray October 25, 2012 at 8:29 pm

I STRONGLY urge the FDA to select Narcolepsy for new “patient-focused” drug development initiatives. This disorder has a devastating impact on the academic, professional and relational lives of patients and their families. In otherwise healthy individuals, this disorder can completely destroy patients’ careers, relationships and their ability to function adaptively day-to-day.

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julie October 26, 2012 at 6:13 pm

Jeanne: Thank you so much for your support of the FDA initiative for narcolepsy. With gratitude, Julie

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Makky's Mom October 28, 2012 at 1:33 am

Letting you know, Julie, that I submitted a letter as well. I also helped Makenna submit a letter too. I thought it would be meaningful and impressionable to hear it straight from a 7 yr old narcoleptic! Here’s what she (we) wrote:

“I don’t know a lot about FDA but my mom tells me you might research new medicines for me. I have Narcolepsy with cataplexy. It is very bad. I feel yucky a lot. I miss a lot of school. Sometimes I can’t play with my friends because I’m too wobbly and I need to sleep. When my cataplexy is bad I fall down a lot. I sometimes fall down the stairs and get hurt.
The doctor says I will have this all my life. I am only 7 years old so that’s a long time. I take medicine 2 times a day to feel more awake. It helps but I wish I didn’t have narcolepsy. I wish I felt better.
If you can do something to help me, please do something to help me. Narcolepsy makes my mommy cry a lot. I know she worries about me. I don’t want my mom to worry so much because I love her. Please help me by finding new medicine for narcolepsy.”

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julie October 29, 2012 at 12:18 am

Makenna and Mom – thank you so much for seding in letters to the FDA. Thank you for sharing Makenna’s letter here on my blog. It is a powerful testimonial. With gratitude, Julie

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John Paul November 10, 2012 at 3:42 pm

Hi!

I am one of your FB friends. Lots of work you do for us PWN!
This FDA initiative, did anyone address the need for more serious consideration to allow PWN to obtain Disability or partial Disability from not being able to work or work full time capacity?
Thank you!

JP

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julie November 11, 2012 at 2:59 pm

Hi John,
The FDA initiative invited patients and loved ones to write in comments about their personal experiences/challenges with narcolepsy. I imagine a portion of these letters discussed work capacity and disability considerations. Definitely an important point to discuss! Thank you so much for checking out my blog!
Cheers,
Julie

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tam kozman May 22, 2013 at 11:34 pm

thank you, julie, for advocating on our behalf!

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julie May 22, 2013 at 11:36 pm

You’re very welcome. Thank you for your support, Tam!

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