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FDA Input Sought

October 20th, 2012

As part of its commitment under the recently approved Prescription Drug User Fee Act (PDUFA V), the FDA will be conducting an initiative, called the patient-focused drug development initiative, to provide for a more systematic approach to obtain the patient’s perspective on the disease severity and the currently available treatments. The intent is to ensure a thorough understanding of the severity of the treated condition and the adequacy of the existing treatment options.

This initiative will be conducted for each of 20 different disease areas over a period of 5 years. The FDA has nominated an initial list of 39 diseases, including ME/CFS, using the following criteria:

  • 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.

The next step in the process is for the FDA to gather public input between now and November 1st on which of disease areas should be selected for inclusion in this initiative. Additional disease areas may also be nominated during this time.

Note that initiative is in addition to the ME/CFS FDA stakeholder meeting that Dr. Woodcock, Director of the Center for Drug Evaluation and Research at the FDA, has already committed to.

How can you help:  For ME/CFS, this is an excellent opportunity to help the FDA better understand how ME/CFS affects the patients. Your support is essential to ensure that ME/CFS is one of the 20 selected diseases.

Please send your comments in by November 1 to ensure that the FDA understands why ME/CFS should be selected as one of the 20 diseases.  

Comments can be submitted electronically, or by regular mail to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Make sure you include the docket number (FDA-2012-N-0967).

Further information on the patient focused drug development initiative and the list of 39 diseases initially nominated can be found here.


 

  1. Carol Jaquith
    October 21st, 2012 at 19:41 | #1

    Where does one send an electronic letter to the FDA
    Carol

  2. Joe Landson
    October 22nd, 2012 at 07:32 | #3

    Jennie, I’ll be at this meeting, and hope to provide a summary in my wry, sarcastic way…

    • Jennie Spotila
      October 22nd, 2012 at 13:45 | #4

      Fantastic, Joe! It doesn’t look like it will be webcast, which is a bummer.

  3. Ruthann Auten
    October 22nd, 2012 at 21:01 | #5

    Any suggestions as to a possible outline the comment should follow and/or what should be highlighted? Organizing my thoughts and writing are very challenging for me.

    • Jennie Spotila
      October 22nd, 2012 at 22:23 | #6

      You should talk about whatever you feel is relevant to ME/CFS and treatment development. The 39 listed diseases were selected according to the following criteria:

      - 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; or
      - 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.

      Talking about how ME/CFS fits these criteria could help focus your comments, as well.

  4. Ruthann Auten
    October 31st, 2012 at 17:13 | #7

    Thank you for your response and for posting Mary Dimmock’s comments to the FDA. I wasn’t able to write a comment myself, but my mom did (almost makes me feel like I am in grade school and not 32 years old). I just typed and edited her comment and sent it in. Even though my brain is fuzzy now, I have a headache and I can barely type anymore I feel good having accomplished this. Thank you for your encouragement.

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