Sunday, June 17, 2018 10:33:10 AM
http://www.faim.org/why-cant-we-use-our-own-stem-cells-to-heal-our-bodies
“All three branches of government uphold the principle that the FDA cannot oversee the practice of medicine. This definition change brings autologous adult stem cell (AASC) therapies, which are the practice of medicine, under FDA oversight. This is the first time in history the FDA has encroached into practice of medicine oversight. In addition, now that the FDA has crossed the line they recently have gone even further and have taken control of tissue practices that have successfully been used for years in the practice of medicine.”
“Clinical and Laboratory Guidelines have already been created to give guidance to physicians and state medical boards to insure safety and reliability. A Patient Registry is in place and accessible for physicians to escalate the advancement of this therapy.”
BIG
“It has always been the intent of all three branches of government to protect the right of the doctor to practice medicine. For this reason, throughout history, it has been clarified that the FDA cannot oversee the practice of medicine. Various court cases have upheld the distinct line drawn by Congress between the FDA and the practice of medicine stating "Congress did not intend the Food and Drug Administration to interfere with medical practice as between the physician and the patient."
“Off-label use by doctors has been considered sacred, important by the courts, and a distinct benefit to society. Many devices are used off-label to help patients. In addition, the action of the FDA violates the judge's order in U.S. v. Evers and ignores his conclusion that off-label use by doctors is important to society. These new regulatory actions by the FDA are a disaster to patients, as each cell type turned from body part to drug costs the nation tremendously in increased costs and delayed access to these therapies.”
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