The FDA has announced a 1 day public hearing to obtain input on the four recently issued draft guidances relating to the regulation of stem cell therapy in the U.S. The restrictive proposed regulations will prevent countless patients from receiving this life-changing treatment. The FDA will consider information from medical professional as well as the public/patients on the finalization of these guidances on April 13, 2016.
Read examples here of how stem cell therapy has been making news for saving patients from disabling, even life threatening illness. The FDA regulations would further limit or stop access to these treatments in America.
WE NEED TO LET OUR COLLECTIVE PATIENT VOICE BE HEARD!!!
Step 1: Register for the FDA Public Meeting
April 13, 2016 8:00 a.m. – 5:00 p.m.
FDA’s White Oak Campus
10903 New Hampshire Avenue
Silver Spring, Maryland 20903
To register by Jan 8th 2015, send an email to: CBERPublicEvents@fda.hhs.gov
Please register even if you can’t attend in person. We are requesting webinar access for those who cannot travel.
Provide the following info in your email.
1. Full name
6. Phone number
7. Your comment
For Affiliation, here are some suggestions:
• Patients For Stem Cells
• Alliance for the Advancement of Cellular Therapies (AACT)
• Stem Cell Pioneers
Comments are not required, but you can include one about your concerns. Please save it for submitting to the Federal Register. Instruction on how to do this will follow.
Here are some comment examples:
As a “No Option Patient” with a disabling chronic disease, I would like the option to be treated with my own cells, especially when all other FDA approved therapies have failed me. Please consider this when rendering your decision on the minimal manipulation of stem cells.
As a patient who has received cell therapy with quality of life benefits I can attest I wouldn’t be alive today if it wasn’t for the adult stem cell therapy I have received. I should have the right to this therapy here in the U.S. without having to travel offshore.
I am a caregiver of a once vibrant, active and intelligent human being. It is heartbreaking to watch the deterioration of a loved one who could potentially benefit from cell therapy. This a travesty beyond measure.
Step 2: Inform your representative
The FDA is a non-elected appointed regulatory body. Citizens have little recourse to object to the control they are trying to take of the practice of medicine. Please inform your elected Representatives of what is happening.
To find your Representative’s contact and email info, click here.
Step 3: Become an informed advocate
Here is the FDA public notice on the meeting:
Federal Register Notice: Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
You will notice that no attempt is made to translate the technical medical jargon into plain language. That’s why we are very lucky to have the support of AACT, whose directors are some of the leading cellular medicine physicians in the world. The healing they have witnessed in the patients they have treated has motivated them to stand up the FDA.
AACT will be providing updates and further education on the FDA’s actions, as well as further instructions on how to submit comments to the FDA before and after the April 13th meeting. Citizen/Patient Membership is free, but consider a donation if you can.
To join AACT click here: AACT Membership
Here are the topics AACT will be addressing:
1) Overview of regenerative cells and potential usefulness to medical practice, explaining the scientific data available for us of non-embryonic stem cells, their safety and ethical acceptance.
2) Forcing US citizens to leave home as medical tourists for untested therapies.
3) Importance of the physician’s role in the “Practice of Medicine” and the physician patient covenant.
4) Patient’s Bill of Rights including access to all potential treatments regardless of costs.
5) Patient’s “Right to Try” laws and the off label use of regenerative cells.
6) Economic (a) and Academic loss (b) associated with restrictive regressive regulations
a) Allowing for patient funded clinical studies in the US.
b) Establishing general and disease specific patient registries designed to collaboratively advance the science and clinical protocols.
7) Bioethical concerns associated with delaying/denying the aggressive testing and development of quality of life improving and life saving therapies.
8) The de facto exclusions of these therapies for children in the US.
Thank you for your efforts!