FDA Initiative Materials

PUBLIC COMMENT SUBMISSION GUIDE
Docket Number FDA-2012-N-0967
Drafted for Narcolepsy Community
By Julie Flygare, JD 10/22/12
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IMPORTANT: PRIVACY NOTICE & ANONYMOUS COMMENTS
FDA allows you to comment anonymously. To do so, fill in the name fields as “Anonymous” or simply leave the name fields blank.  Do not list your name anywhere in your comment or attached letter. If you choose to use your name, it may be included in a public docket and on the Internet.

HOW TO SUBMIT PUBLIC COMMENT:

– Organization Name (Required): NARCOLEPSY NETWORK
– Submitter’s Representative (Optional):  Leave Blank
– Category (Required): INDIVIDUAL CONSUMER

Comment field limited to 2,000 characters. I suggest writing a short comment and submitting letter as an attachment.  Short comment example: I urge FDA to select “narcolepsy” as one of the twenty disease areas chosen for Patient-Focused Drug Development Program. Please see attached letter. Thank you.

 Choose your personalized saved letter “My FDA Letter” 

 

 

Thank you for making a difference for narcolepsy! Spread the word.

EXAMPLE NARCOLEPSY PATIENT LETTER

[DATE]

Food and Drug Administration
Division of Dockets Management (HFA-305)
5630 Fishers Lane, Room 1061
Rockville, MD 20852 

RE: Docket Number FDA-2012-N-0967

            I would like to express my thanks to the Food and Drug Administration (FDA) for nominating “narcolepsy” as a disease area considered for the new patient-focused drug development initiative. I urge FDA to please select “narcolepsy” as one of the twenty disease areas chosen for this important effort.

            Narcolepsy is a neurological autoimmune chronic sleep disorder affecting 1 in every 2,000 people in America. The disorder’s affect upon quality-of-life is comparable to epilepsy and Parkinson’s disease. Narcolepsy is a complex disorder. Not all patients experience all the major symptoms to the same degree.

            As an orphan disease, there is no known cure for narcolepsy and better solutions are needed as soon as possible. Even with the best treatments available, narcolepsy severely inhibits critical cognitive functions and compromises education, employment, and personal lives. As a lifelong disorder, narcolepsy subpopulations requiring special consideration include children, elderly patients and pregnant women. 

            Providing FDA with a more comprehensive understanding of the narcolepsy patient experience should go a long way to more accurately informing regulatory decision-making and, ultimately, facilitating the approval of effective treatments.   

[In a few sentences, explain that impact narcolepsy has on your life.
Suggested Topics:
• Diagnosis: major event leading to diagnosis OR long time undiagnosed and/or misdiagnosed.
• Affects on your ability to work, go to school, raise a family, etc.
• Difficulty with treatment options and side effects.] 

In closing, I once again ask FDA to please select “narcolepsy” for the new patient-focused drug development initiative. Thank you for your time. 

             Sincerely,
            [Name]    
            [Address]  OR  [Anonymous: do not list name/address]  
 
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4 Comments

  1. […] 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 […]

  2. Representing People with Narcolepsy at the FDA on October 26, 2012 at 3:18 pm

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  4. […] 2012)Join Me: Urge FDA to include Narcolepsy in new patient-focused initiative (October 2012)FDA Initiative Materials (October 2012)A Note of Thanks & FDA Update  (November 2012)Julie Flygare Represents […]

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