This issue is important. If you are confused as to what to write, it's better to copy and paste the example below rather than taking no action. You can use Stem Cell Pioneers or PatientsForStemCells as a group name or anything else you want. The form prompts you what you need to fill out. It is very simple and takes only a minute or two to complete. We are under the deadline gun with this one, so please send your comments right away.
Thanks to member SammyJo for putting this together.
Take Action by July 8th: Tell The FDA Your Stem Cells Are Not A Drug!
The public has the opportunity to to present comments to the FDA regarding regulation of adult stem cells, outlined at
Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers; Availability
Docket # FDA-2013-D-0446
This draft doesn't address stem cell therapy directly, rather it is for Investigational Drugs. They are trying to convince us our own stem cells are drugs, subject to years of trials before we can have this life saving therapy. Now is your chance to tell the FDA they are on the wrong track.
Go to HERE to make your comment: http://www.regulations.gov/#!submitComment;D=FDA-2013-D-0446-0001
You will need to find your Representative to enter on the form at http://www.house.gov/representatives/find/
For the Category question, select: Individual Consumer (scroll to the very bottom to find it)
Example comment (modify to reflect your interest in stem cell therapy):
I am a patient with secondary progressive MS, non-responsive to FDA approved drugs. Expanded autologous mesenchymal stem cell therapy is the only thing that has helped me.
The FDA should rescind its April 1, 2006 change to the wording of 21 C.F.R. 1271.3(d) by replacing the current term “transfer into a human” with its predecessor, “transfer into another human….”
This April 2006 change which moved autologous cell therapy into the category of Investigational Drugs should be invalid and unenforceable because it was made without giving the public notice to submit comments.
The framework to regulate autologous adult stem cells and therapies should use the same regulatory oversight currently used for in-vitro fertilization.
Alternatively, the FDA could adopt a framework similar to the European Medicines Agency (EMA) Hospital Exemption for Advanced Therapies, especially for low risk autologous cell therapies.
http://www.patientsforstemcells.org/...re-not-a-drug/
The # of comments can be tracked here http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-0446-0001
Thanks to member SammyJo for putting this together.
Take Action by July 8th: Tell The FDA Your Stem Cells Are Not A Drug!
The public has the opportunity to to present comments to the FDA regarding regulation of adult stem cells, outlined at
Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers; Availability
Docket # FDA-2013-D-0446
This draft doesn't address stem cell therapy directly, rather it is for Investigational Drugs. They are trying to convince us our own stem cells are drugs, subject to years of trials before we can have this life saving therapy. Now is your chance to tell the FDA they are on the wrong track.
Go to HERE to make your comment: http://www.regulations.gov/#!submitComment;D=FDA-2013-D-0446-0001
You will need to find your Representative to enter on the form at http://www.house.gov/representatives/find/
For the Category question, select: Individual Consumer (scroll to the very bottom to find it)
Example comment (modify to reflect your interest in stem cell therapy):
I am a patient with secondary progressive MS, non-responsive to FDA approved drugs. Expanded autologous mesenchymal stem cell therapy is the only thing that has helped me.
The FDA should rescind its April 1, 2006 change to the wording of 21 C.F.R. 1271.3(d) by replacing the current term “transfer into a human” with its predecessor, “transfer into another human….”
This April 2006 change which moved autologous cell therapy into the category of Investigational Drugs should be invalid and unenforceable because it was made without giving the public notice to submit comments.
The framework to regulate autologous adult stem cells and therapies should use the same regulatory oversight currently used for in-vitro fertilization.
Alternatively, the FDA could adopt a framework similar to the European Medicines Agency (EMA) Hospital Exemption for Advanced Therapies, especially for low risk autologous cell therapies.
http://www.patientsforstemcells.org/...re-not-a-drug/
The # of comments can be tracked here http://www.regulations.gov/#!documentDetail;D=FDA-2013-D-0446-0001