Please, please, please help get migraine included in the FDA’s exciting new patient-focused program by telling them how desperately migraine needs their attention. Inclusion would mean way more time and money spent on — and research and drug development for — this life-altering illness that is typically dismissed as “just a headache.” The deadline is next week, so don’t delay.
In this new program, the FDA will choose 20 illnesses and host a meeting on each illness for patients, caregivers, physicians and other interested parties to cover an “in-depth review of the needs related to treatment, the current state of treatments, disease burden, the human side of living with the disease, and other issues of possible relevance to reviewing treatments that may come before the FDA for review,” according to patient advocate Teri Robert.
What You Can Do
The FDA is currently accepting public comments to help decide which illnesses should be included in the 20. This is where you come in — I beg you to submit a comment highlighting the importance of studying migraine. For most impact, it should be concise, focused and not overly emotional. Comments are due by next Thursday, November 1, so please don’t wait.
Topics to Address in Your Comment
The FDA is specifically looking for the following criteria when deciding the diseases to include in the program. Please address as many as are relevant to you in your comment.
- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living
- Disease areas that reflect a range of severity
- Disease areas for which aspects of the disease are not formally captured in clinical trials
- Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly)
- Disease areas that represent a broad range in terms of size of the affected population
- Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
Facts and statistics you may want to include in your comment, which Teri Robert put together.
Where to Submit Your Comment
Submit your comment at FDA’s Prescription Drug User Fee Act Patient-Focused Drug Development Public Meeting and Request for Comments page and click the blue button that says “comment now.”
- Brief explanation of the program and suggestions to help with writing your comment: FDA Calls for Citizen Comments About Migraine: Be Heard
- Detailed explanation of the program: FDA Wants to Hear from Us About Migraines
- Diana Lee’s public comment to the FDA
A Final Plea
Putting together your comment may take a little time, but it might make the difference in getting migraine recognized as a real and debilitating illness. This will lead to more funding for research into treatments and causes of migraine. Such discoveries could benefit you in the future and will certainly help your children or other young loved ones who have migraine.