The FDA has classified our own stem cells as drugs, subject to years of drug trials before we can access this life saving therapy. Disabled and seriously ill patients who have exhausted all other medical options are forced to leave the U.S. to seek cell therapy in other countries.
The public has the opportunity until July 8th 2013 to present comments to the FDA regarding regulation of adult stem cells.
Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers; Availability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, since the FDA has classified stem cells as such.
Here are the steps to tell the FDA what you think
1. Find your Representative name to enter on the comment form.
Save your comment and send to your Representative too.
2. Go HERE to make your comment to the FDA. See example below.
3. For the Category question, select “Individual Consumer”, unless you fit in a different category.
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.
Source: FDA Stem Cell Regulation and the English Language: switched at birth? Mary Ann Chirba, J.D., D.Sc., M.P.H. August 11, 2011
You can track how many comments are made at the Federal Register here.
If you are new to the debate about the FDA overreach of authority in classifying our stem cells as drugs, please see The History of FDA Control of Your Body.
Thank you for your help with this important matter. People with no-option medical conditions will benefit if they can remain in the U.S. for stem cell therapy, rather than taking on the additional ordeal of long distance travel.
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