FDA’s position on adult stem cells is contained in multiple places and can be tough to decipher.
Basically, to treat disease, your adult stem cells need to be grown a bit ( incubated) in culture. If you don't do this, the stem cells are unlikely to help the patient. However, FDA's current regulatory framework makes this type of cell culture the manufacture of a new drug, essentially removing cell therapy from your doctor's black bag (until the FDA approves your stem cells as drugs for each and every medical condition). So while your doctor could do all of this safely in a physician run lab and begin treating a host of diseases, you have to wait 5-20 years for access to your own stem cells (as a drug).
So what's the public health rationale for why you would want to regulate the patient's own stem cells as a drug? If we look at mass production of anything such as food, drugs or someone's cells placed in a vial, the public health implications can be tremendous. A bad batch of food or drugs can make a lot of people very sick very quickly. However, an autologous procedure is very different, in that it involves taking one person's tissue and placing it back into the same person. For example, disease transmission risks from one person to another don't apply; the idea of one "bad batch" of anything making many people sick doesn't apply. The worst that can happen is that one person gets sick from something that happened to their own tissue. This is therefore not something for mass production rules, but rather things like professional treatment guidelines and implantation registries.
As we have been discussing, the FDA’s position on your adult stem cells is that they are biological drugs. How did this happen? FDA’s definition of stem cells (a type of ‘”human cell, tissue, or cellular or tissue-based products” (HCT/Ps)) is found at 21 CFR § 1271.3(d).
As revealed HERE, that definition has undergone a very significant change over the past five years. Originally, HCT/P was defined as follows: “any human tissue derived from a human body and intended for transplantation into another human…” Now, however, HCT/P is defined as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” Thus, the regulation currently in effect purports to give FDA the authority to regulate even those tissue products being used for autologous purposes (i.e. tissue products being used in a bypass surgery), and therefore gives the FDA more authority than Congress has ever authorized. Congress does not hide elephants in mouse holes, and it has never granted FDA the authority to regulate the practice of medicine.
Why is this important? 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.
Please take a minute right now to send the following to the FDA/Ombudsman (feel free to edit/add your own comments):
Dear sirs,
I oppose the change made in 21 CFR § 1271.3(d) from “any human tissue derived from a human body and intended for transplantation into another human…” (2004 and prior) to “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” (recent regulation). This change allows FDA to regulate the practice of medicine, even though Congress never gave the FDA such power. Please put this regulation change to public comment as is required by law.
Please join the ICMS and protect these therapies
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