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:
- Customize Sample Letter (below) and Save to Desktop with title like “My FDA Letter”
- Go to Federal Registery (https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for)
- Comment Now!
– 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
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.
• 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] Return to blog post about FDA Initiative
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