FDA

by Jody Smithhands around the world

The FDA held the Myalgic Encephalomyelitis and Chronic Fatigue Syndrome Webinar: Working Together for Change on November 15, 2012. An invitation had been issued earlier to Phoenix Rising and anyone interested in attending.

There was not much mention of ME/CFS until well into the webinar, which surprised me and left me dismayed at first. Instead, speakers talked about the origins and history of the FDA, as well as about several other severe health conditions including HIV/AIDS, cystic fibrosis and muscular dystrophy. An advocate for CF and another for MD spoke at length about the challenges that faced them in the early days of advocacy in bringing attention, funds and support to those suffering with these diseases.… Read More

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Image courtesy of imagerymajestic at FreeDigitalPhotos.net

by Jody Smith

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.

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Goal

To accelerate treatments and access to treatments for ME/CFS patients (in the absence of a wholly agreed upon definition, a diagnostic biomarker* and defined subset populations).

Objectives:

1.   Expediting treatments to patients – distinguish the various accelerated pathways including and not limited to fast tracking, accelerated approvals, post-marketing trials, and other regulatory mechanisms

Discussion Considerations:

  • Range of treatment trial strategies (combinations of drug treatments and/or broad-spectrum of      patients)
  • Parallel tracking
  • Expanded population trials (increasing population size as shows benefit)
  • Priority reviews
  • Use of cross functional review teams, etc.

2.  Examine and define benefit risk and quality of life for chronic illnesses; specifically looking at ME/CFS

Discussion Considerations:

  • How does FDA currently evaluate chronic illnesses
  • Patient and clinician considerations on risk and benefit
  • Safety versus risk
  • Severity/morbidity
  • Persons freedom to make health choices
  • Promote and protect public health
  • Other chronic illnesses

3.   … Read More

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Posted by Cort Johnson

(Things are finally starting to move…The FDA is responding but no meeting dates are set. Stop now and we risk losing our chance; keep working and we can bust this thing wide open.  We are on the brink of getting a historic meeting at the FDA…

The FDA can be very pro-active in the drug approval process – we’re simply asking that they be pro-active with the only major disorder they’ve never approved a drug for. – ME/CFS! Let’s keep the pressure on by emailing the feds every day until the 25th….Cort.)
_______________________

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS.Read More

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Posted by Cort Johnson

(This was never going to be easy….ME/CFS has been ignored by every federal agency for over 2 decades and its going to take time and work to break down those walls.  Let’s send a message that we are no longer willing stand for being ignored…Thanks to Mary Dimmock, Bob Miller and others for standing up for  the possibility of equal treatment for ME/CFS and producing this. )

CALL FOR THE FDA TO HOLD A STAKEHOLDER MEETING – SECOND LETTER!

May 14, 2012

To All who took ACTION requesting THE FDA TO HOLD A STAKEHOLDERS MEETING for ME/CFS

THANK YOU!!

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Posted by Cort Johnson

For decades, ME/CFS (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) has devastated the lives of patients and our loved ones, leaving us with an alarmingly low quality of life. Today, ME/CFS affects the lives of more than 1 million Americans of both sexes and all ages at an annual cost of at least $21 billion in direct costs and lost productivity.

As patients and loved ones, we have suffered too long with too little research, a disbelieving medical community and no approved drug treatment specifically for ME/CFS.

This has to change!  We know that we need many things, such as more money for research.Read More

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