Your chance to help change FDA rules on the use of your own stem cells by a doctor
Have you ever found yourself angry with FDA policies or rulings? Wished you could change something that’s just plain wrong? This may be your supreme chance. The FDA has opened its doors to public input on existing regulations http://es.bna.com/federal1/20110427/hhs76p23520prule20110427.html:
In accordance with Executive Order 13563, “Improving Regulation and Regulatory Review,” the Food and Drug Administration (FDA) is conducting a review of its existing regulations to determine, in part, whether they can be made more effective in light of current public health needs and to take advantage of and support advances in innovation. The goal of this review of existing regulations, as with our other reviews, is to help ensure that FDA’s regulatory program is more effective and less burdensome in achieving its regulatory objectives. FDA is requesting comment and supporting data on which, if any, of its existing rules are outmoded, ineffective, insufficient, or excessively burdensome and thus may be good candidates to be modified, streamlined, expanded, or repealed. As part of this review, FDA also invites comment to help us review our framework for periodically analyzing existing rules.
So which regulation deserves your attention? How about FDA 21CFR1271 (2004)? This regulation forbids doctors taking stem cell rich tissues from patients and doing anything to them beyond “minimum manipulation”? (Basically this means doctors can take stem cell tissue and give it back to patients but little else. If, for instance, a doctor isolates and cultures stem cells from a patient’s bone marrow or fat tissue, that doctor — under current FDA regulations — has in effect created a new drug. And as a “new drug” these cells must receive FDA approval to be used.)
Interested in knowing more and maybe giving Uncle Sam your 2 cents worth? Well, patient advocate Barbara Hanson, who moderates a well known stem cell discussion board (Stem Cell Pioneers), has outlined precisely what people need to know and do to get FDA 21CFR1271 changed to allow doctors to take stem cell rich tissues and go beyond “minimum manipulation.” Here is a link to Mrs. Hanson’s “How to do it, to it” post: http://www.stemcellpioneers.com/showthread.php?p=13618#post13618
Read the post and then, well,…do it, to it!
