Joanne Marie Quinn - Comment

In reference to 21 C.F.R. 1271 and regulation of autologous stem cell therapies. The regulation needs to be repealed for many reasons. 1. The use of autologous stem cells (AASC) between the physician and the patient and falls within the definition of the practice of medicine by the House of Delegates of the Fed of the State Med Board. 2. It is illegal for the FDA to oversee the practice of medicine. This has been confirmed in the courts, by legislation and by the administration. 3. The FDA brought AASC's under its jurisdiction by changing the definition of tissue in the reg 21 C.F.R. 1271 without public comment. The Administrative Policy Act requires all regulations to be open to public comment prior to issue. 4.AASC therapies are outside the jurisdiction of the FDA because they do not involve interstate commerce and do not threaten the public. They are only between the doctor and the patient. 5. Since treatment using AASC is the practice of medicine, any part of the treatment including harvesting, processing and reinfusing of the stem cells is under the jurisdiction of the State Medical Boards, not the FDA. 6. AASC therapies are very similar to Invitro fertilization and heart bypass which are also the practice of medicine. 7. Wrongful oversight of AASC therapies by the FDA has halted innovation and competition. 8. The use of AASC therapies will save the health care system large sums of money as these therapies are less expensive than therapies currently available for the same diseases/injuries. 9. Many years of research supports the fact that AASC therapies are comparitively safe and treat many diseases/injuries which have no other effective treatment currently such as MS, Alzhiemers's, Parkinsons, spinal injuries, etc. Solution: The FDA issue a Compliance Policy Guide separating AASC therapy from all other stem cell therapies placing AASC therapy, including all aspects of it, under the juridiction of the State Medical Boards.