1. Patients launch $1.27 million crowdfunding campaign for ME/CFS gut microbiome study.
    Check out the website, Facebook and Twitter. Join in donate and spread the word!
AVIVA Semi-Finals: National ME/FM Action Network is competing for $100,000
The National ME/FM Action Network in Canada is competing for $100,000 for biomedical research of ME and FM in the Aviva Community Fund contest. With thanks to all who helped, they made it through the first round of voting into the Semi-Finals.
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Tell the FDA What You Think, Through Comments or Public Meeting

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Oct 16, 2012.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    [​IMG]

    by Jody Smith

    View the Post on the Blog

    The Food and Drug Administration has deemed ME/CFS to be one of 39 conditions that may receive their special consideration. But of these 39, only 20 conditions will be picked. If ME/CFS is one of those 20, patients' comments will be heard through public meetings and through mailed and emailed messages.

    The FDA evaluates and approves drugs before they can be put on the market. They may also create incentives that will encourage companies to turn their focus to ME/CFS.

    The FDA is holding a public meeting and is looking for input from ME/CFS patients about the FDA's patient-focused drug development initiative. The goal is to hear patient perspectives on various conditions. The FDA is interested in knowing what symptoms patients deal with as well as how effective the available treatments are for the condition.

    MC/CFS is one of the conditions on the preliminary list of nominated disease areas for this initiative, that may potentially be visited at a future public meeting. The FDA invites comments through a public docket and at a public meeting.

    Public meetings will be conducted to talk about such matters as the condition's impact on the patient and the severity of symptoms. Patients are asked to communicate what matters to them most. They are asked to evaluate how adequate the present treatment alternatives are for them.

    You can also contact the FDA and share your story by mail or email. You have until November 1, 2012 to let the FDA know your thoughts.

    What should you tell them? Whatever is important to you.

    Describe the effects of ME/CFS on your health. Let them know what types of treatments have helped or hurt you, or did nothing for you. Pass on the names of doctors and researchers that have been beneficial to ME/CFS. Whatever is on your mind, whatever your biggest concerns, fears or hopes are, let your voice be heard.

    People from outside of the United States are welcome to comment.

    Write to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Be sure to include the docket number FDA-2012-N-0967. Submit your comments at
    http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967

    Time is running short if you want to attend the public meeting. It will be held Oct. 25, 2012. You must be registered by Oct. 18, 2012.

    The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. To register, send an email to PatientFocused@fda.hhs.gov with your contact information. Include your name, title, affiliation, address, email address and phone number.

    It costs nothing to register, but space may be limited. Your registration will be confirmed.

    To learn more, contact Andrea Tan or Robert Yetter.

    Andrea Tan can be reached at the Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1168, Silver Spring, MD 20993, 301-796-7641, FAX: 301-847-8443. You can email her at Andrea.Tan@fda.hhs.gov

    You can reach Robert Yetter at the Center for Biologics Evaluation and Research (HFM-25), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-1448, 301-827-0373.


    Sources:

    Tell FDA why ME/CFS should get special attention by NOV 1:
    http://forums.phoenixrising.me/index.php?threads/tell-fda-why-me-cfs-should-get-special-attention-by-nov-1.19584

    Prescription Drug User Fee Act Patient-Focused Drug Development; Public Meeting and Request for Comments:
    https://www.federalregister.gov/articles/2012/09/24/2012-23454/prescription-drug-user-fee-act-patient-focused-drug-development-public-meeting-and-request-for

    View the Post on the Blog
     
  2. K2 for Hope

    K2 for Hope ALways Hoping

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    Thanks, Jody.

    So, all we have to do is contact them via email and let them know our "stories", in a shortened version for most of us...

    And let them know why ME/CFS should get "special attention" especially in the FDA world where there is little for patients except ultra expensive medications.

    I'm in! (Thanks)
     
  3. SpecialK82

    SpecialK82 Senior Member

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    Done - hope everyone just takes a moment to do this. Even if you don't have the energy to write much - just say - "Please select Chronic Fatigue Syndrome!" in the comment section - let's flood them with responses.
     
    justinreilly likes this.
  4. Jody

    Jody Senior Member

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    K2 for Hope,

    That's my understanding. Not a bad deal. :)
     
  5. Omar88

    Omar88 Senior Member

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    Help me am not sure how to do it !!
     
  6. HowToEscape?

    HowToEscape? Senior Member

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    I think we need to set out a list of common themes - *not* to send a copy/pasted list of complaints, but to help cut through brain fog while composing messages. 18 hours is not enough for most of us to get 3 hours of clear writing.

    Anyone capable of proofreading and editing here? I could have done that before I got hit, not now.
     
  7. Hope123

    Hope123 Senior Member

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    Just to be clear:

    -- OCTOBER 18 is the deadline if you want to attend the meeting in DC Oct. 25.

    -- NOVEMBER 1 is the deadline if you want to SUBMIT comments to the FDA. So there is a little over 2 weeks to submit comments.
     
  8. SpecialK82

    SpecialK82 Senior Member

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    Omar, just need to follow link below, then click the blue "Comment Now!" box. Add your personal information and your comment, it can be as short as you want it to be, just make sure to ask that Chronic Fatigue Syndrome (that's what name they use) is selected for special consideration.

    * please note that all comments will be viewable by the public

    http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0967
     
  9. anniekim

    anniekim Senior Member

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    Which category is it in? Many thanks
     
  10. Nielk

    Nielk

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    When I go to the page it says that 249 comments have been received but when I press "view all" it only shows 24 comments?
     
  11. Jody

    Jody Senior Member

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    Anniekim,

    I'm not sure I understand your question. Which category where, is what in? :)
     
  12. Jody

    Jody Senior Member

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    I saw that too, Nielk. I don't know what it means either.

    Maybe someone else knows the answer to that?
     
  13. Timaca

    Timaca Senior Member

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    The problem is that the FDA cannot develop a drug for CFS/ME because there is no understanding as to what is causing the illness. More research needs to go into finding the cause(s) of the condition before drugs can be made to treat the condition.... Just my 2 cents as I looked over the FDA website....
     
  14. SpecialK82

    SpecialK82 Senior Member

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    For Category - I used the drop down menu next to it and scrolled to the bottom and it says "Individual Consumer", that is what I picked.

    Also, it won't submit the Comment if the "Organization" field is blank, so I wrote in "none".
     
  15. anniekim

    anniekim Senior Member

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    When I submit my comment on the left hand side there is a bar where I have to choose which category i want to submit my comment to. Many thanks
     
    Jody likes this.
  16. anniekim

    anniekim Senior Member

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    Ah, great, thanks
     
  17. Nielk

    Nielk

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    Timaca,

    Many conditions without known causes have FDA approved drugs to treat them. For example: Migraines, Crohn's, Fibromyalgia, MS....and many more.
     
    beaker and Timaca like this.
  18. Bob

    Bob

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    Timaca likes this.
  19. medfeb

    medfeb Senior Member

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    HowToEscape

    You asked about common themes. Not sure if it helps but the FDA has a set of criteria that they are using to select the disease areas.
    • 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.
    I found it helpful to keep these in mind in writing my comment
     
    SpecialK82 and Timaca like this.
  20. Timaca

    Timaca Senior Member

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    OK.....comment posted. :)

    Timaca
     

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