Let’s be honest: Congress does not hide elephants in mouse holes. Or in this case, the authority of any governmental agency to willy-nilly expand its charter. Congress has never given the FDA the authority to regulate the practice of medicine. Nor should it. Oversight of the practice of medicine is a right reserved to the States, not the Federal Government.
Yet, attempting to regulate the practice of medicine is exactly what the FDA is trying to do. How? The FDA’s position on your adult stem cells is that they are biological drugs. How did this happen? FDA’s definition of stem has undergone a very significant change over the past five years. Originally, the FDA defined adult stem cells (or human cell tissue / tissue based products) as “any human tissue derived from a human body and intended for transplantation into another human…” Now, however, they are defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” This minor change in phraseology purports to give FDA the authority to regulate even those tissue products being used for autologous purposes. And not just stem cells. We are talking about tissue products being used in a bypass surgery. This is insane? Would anyone allow the FDA to walk into an operating room and stop a cardiologist from performing a heart by-pass?
So, why is this important? Why should we care? The FDA made these changes to the law without public comment. Federal law provides that the FDA cannot make new regulations without noticing the public and offering the public the opportunity to comment. In this case, had the FDA noticed the public of a proposed change to 21 CFR § 1271.3(d), the proposed change would have infuriated doctors and others involved in medical procedures because the new regulation purports to give the FDA authority to regulate the practice of medicine.
Why make this change? What was in it for FDA? By changing one simple phrase, the agency has given itself new sweeping powers to regulate stem cells as biological drugs. In fact, the very existence of CBER (the cell based therapy group at FDA) depends on this little change of phrase. Without it, the FDA has no authority to regulate the patient’s own stem cells as a drug. But with it, FDA gives itself unheard of authority and a whole new section of the federal government has a reason to exist.
As a doctor, you should be justifiably concerned about the FDA’s attempted overstep its charter. Stem cells today… What’s next? PRP? In Vitro Fertilization? Prolo-therapy?
As a patient, you should be incensed that that our own government is denying us access to safe and effective treatments options.
As Americans, we should all be embarrassed that while the FDA dithers about trying to stop doctors from practicing medicine, patients are suffering from conditions that can be treated with autologous, adult stem cells.
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