FDA Stakeholders Effort: An Update

Background and Status

For the past year a small team of ME/CFS advocates laid the foundation for a request to the FDA for a Stakeholder Meeting. First we worked on understanding the FDA’s mission, jurisdiction, regulatory statutes and latitude. Then we built support in Congress. Then we reached out to you.

We knew that FDA drug approvals often result in further drug approvals, increased research funding and have the potential to alter how the medical community views a disorder. The FDA’s approval of Lyrica in 2007 not only altered how that disorder was viewed but was quickly followed by two more drug approvals. We knew that a FDA drug approval could create a profound shift in how many researchers and physicians view ME/CFS.

SUCCESS to Date:

  • Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research committed to the stakeholder meeting to be held early fall.
  • Senators Casey (PA), Blumenthal (CT) and Hagan (NC) sent letters to the  DHHS/FDA supporting the Stakeholders Meeting.

Your team for the ME/CFS & FDA Stakeholder meeting:

  • Robert Miller, ME/CFS Patient, Reno Nevada
  • Pat LaRosa, President; Betty McConnell, former Co-President; and Billie Moore, Board Member, Advocacy Committee Chair- New Jersey Chronic Fatigue Syndrome Association
  • Denise Lopez-Majano, Speak Up About ME, parent of two ME/CFS young adults
  • Mary Dimmock, parent of ME/CFS patient; formerly with Pfizer
  • Marly Silverman, PANDORA
  • Lori Chapo Kroger, CFS Solutions of West Michigan
  • Cort Johnson, President Phoenix Rising
  • Nancy McGrory Richardson, representing NJCFSA and PANDORA, also part-time Education and Outreach Director for Hemispherx.

The Way Forward

  • Your team is in contact with Dr. Woodcock’s office and is in the early planning stages of the meeting. (similar to the meetings held for HIV/AIDS)
  •  Our commitment is to you and advancing treatments for ME/CFS
  •  We will be sending out information as the meeting develops for your input.

Initiatives

There are currently two related but separate patient driven initiatives

  1. FDA Stakeholder Meeting - A Request for the FDA Stakeholder meeting addressing accelerated treatment development and expanded access to treatments.
  2. Strategic Plan - A continuing call for DHHS to develop a strategic, coordinated and fully funded response to ME/CFS which includes the FDA and drug approval as one of 4 key priorities.

In addition to the patient-driven initiatives, there is also a cross-DHHS Ad-Hoc internal committee which discusses ME/CFS related issues.  This was referenced in an email sent to some of the CFS community (see email from FDA);  if you received this email, comments were to be sent to David Banks – please copy Bob Miller on any contact with FDA at the this email address (mebobmiller42@yahoo.com).

 

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