Anonymous - Comment

Docket No. FDA–2011–N–0259 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Center for Biologics Evaluation and Research 21 CFR 1271 Changes made to 21 CFR 1271 in 2004 with regard to “more than minimally manipulated” autologous human cells being treated as an Investigational New Drug requiring a Biologics License Application are overly burdensome and infringe upon the practice of medicine, which FDA does not control and is regulated by the several states FDA has recently asserted that a physician practicing medicine in his or her own medical practice using the patient’s own cells and who meets the definition of “more than minimal manipulation”will be treated the same as a company mass producing drugs. This is concerning, as FDA has stated many times that it does not regulate the activities of physicians These regulations create an environment where patients who might benefit from the use of their own cells are being harmed by excessive FDA regulation.  These federal regulations destroy innovation by physicians and as a result harm the economic recovery. These federal regulations were issued without an appropriate public comment period required by the Administrative Procedures Act and to this day, the FDA has yet to fully comment on the multiple complaints it has received from medical professional organizations and industry that the 21 CFR 1271 regulations infringe on the practice of medicine. Autologous stem cell therapies that involve one patient being treated with his or her own stem cells do not involve interstate commerce nor are they a threat to the public at large. Whatever risks exist in autologous cellular therapies are comparable to those encountered by patients receiving routine surgical procedures, the practice represents no threat to public health, welfare, safety or the environment. The FDA should issue a Compliance Policy Guide (CPG) that makes clear that it does not regulate a physician using autologous HCT/P’s to treat his patients.