Carl Measer - Comment

FDA Center Regulating the Product-CBER Cite: 21 CFR 1271 Brief Description of Problem: -Currently, “more than minimally manipulated” (MTMM) autologous human cells being are treated as an IND requiring a BLA which is overly burdensome and infringes upon the practice of medicine -For example, FDA has recently asserted that a physician practicing medicine with autologous MTMM cells 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, destroy innovation by physicians and as a result harm the economic recovery. -In addition, these federal regulations were issued without an appropriate adherence to the APA and FDA has yet to fully comment on the multiple complaints it has received from medical professional organizations that the regulations infringe on the practice of medicine. - Autologous cell therapies do not involve interstate commerce nor are they a threat to the public at large. In fact, whatever risks exist in these therapies are comparable to those encountered by patients receiving routine surgical procedures Economic Impact: Less regulation will mean lower costs for the agency Proposed Solution-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 or her own patients as part of a medical practice regardless of the level of manipulation of the cells. On the other hand this CPG should clearly state that a manufacturer who mass manufactures HCT/P’s and holds MTMM HCT/P’s for sale in interstate commerce is regulated by FDA