History of How the FDA Took Control of Our Bodies
In the late 1990’s, for the first time in history, the FDA encroached into the practice of medicine. The FDA made autologous adult stem cell therapy subject to the same regulatory oversight as mass-produced pharmaceutical agents. Without compliance to the Administrative Procedures Act, requiring an “extensive public comment period,“ the FDA managed to expand it s authority without input from patients and their doctors.
The ”Manipulation” Line
In the early 1990’s, the cells in your body were like any other body part that could be used by a physician and moved from one area to the next. They were body parts like a kidney or a heart. That was before an unprecedented power grab by the FDA.
In the late 1990s, the FDA proposed that the cells in your body should be classified as drugs. Despite being met with stiff resistance, the FDA decided that, if the cells from your body were made more potent by being expanded to larger numbers, the cells would be classified as drugs, even though the cells are still your own cells. This was known as the “minimal manipulation” rule, later codified in 21 CFR 1271.1-3. In the 1990’s, this ruling only applied to someone else’s cells (allogeneic) that were manufactured like drugs, which made some sense.
2006 Midnight One Word Language Change
The FDA, without the proper notice and without the public comment-making period legally required by the Administrative Procedures Act, made a one word midnight change in the 2006 federal register. It changed a single word from “another” to “a”. By doing this, the FDA expanded its regulatory authority from simple control over someone’s cells used as a transplant from “another” person (allogeneic use), to all cells (including autologous use) from “a” person. With this one work change, the FDA granted itself sweeping new authority over your body.
2008 Physician Processing is Added
Up until 2008, it was assumed that the FDA only meant to apply its rules to pharmaceutical companies that were processing cells. Then in 2008, the FDA went after a physician’s office that was using the patients own (autologous) cells and treated the small doctor’s office like a large Pharma company. This necessitated a suit by the doctor’s office against the FDA, but the chain of events extended the FDA’s authority even further, as now your local family doctor was suddenly under the same cell-based regulations as Pfizer.
2010-2011 Addition of Adipose Stromal Vascular Fraction (SVF)
In 2010 and 2011, the FDA decided to place fat (adipose) tissue, processed at the patient’s bedside to release stem cells, into the same category as prescription drugs. The FDA made this intention clear through letters to several parties that asked the Tissue Reference Group whether this simple processing of fat was something the FDA intended to control. In addition, the FDA submitted Warning Letters to Intellicell Biosciences and to a Dr. Young, codifying its intent to regulate fat tissue as a drug.
The FDA has gone from no control over your body’s stem cells as drugs, in the 1990’s, to classifying an ever increasing number of your body tissues as drugs. This is despite massive opposition from the following industry groups, to name but a few:
♦ American Red Cross
♦ Society for Assisted Reproductive Technology
♦ Osiris Therapeutics Inc.
♦ Northwestern University
♦ Hyman, Phelps & McNamara
♦ Biotechnology Industry Organization
♦ American Society of Clinical Oncology
What is the impact of classifying simple medical procedures as prescription drugs? The FDA has taken procedures that should by now be routinely performed as the standard practice of medicine, and instead placed them into a glacially slow drug approval process. Countless sick patients have been denied access to their own stem cells that may well cure or mitigate their disease.