The U.S. Food and Drug Administration held public hearings for two days this week to allow for public commenting on proposed guidance relating to the regulation of human cells, tissues or tissue-based products.
In its current form, this guidance will classify a woman’s own fat tissue as a drug when used in breast reconstruction procedures. This is certainly bad news for the over 100,000 female cancer patients who seek this procedure each year.
According to the FDA, the sole purpose of a woman’s breast is to lactate. Of course that begs the question of what the purpose of a man’s breast might be but we will leave that for another day. Since fat from other parts of the body does not produce milk, it cannot be transferred into a woman’s breast.
Specifically, in its industry guidance entitled Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance, the FDA states, “The basic function of breast tissue is to produce milk (lactation) after childbirth. Because this is not a basic function of adipose [fat] tissue, using HCT/Ps from adipose tissues for breast augmentation would generally be considered a non-homologous use.” “Homologous use” refers to a tissue’s ability to serve the same “basic function or functions” as the tissue into which it is being transplanted. So in this case, “non-homologous” use equals FDA-regulated “drug”.
That’s right ladies. Your fat tissue is an FDA-regulated drug if your doctor wishes to use it to help reconstruct your breasts following a mastectomy unless she goes through the FDA drug approval process, which can take a decade or two and cost upwards of 2 billion dollars. Needles to say, this is a financial burden that no doctor, clinic or hospital can bear. Once finalized, this new guidance will effectively shut the door on using a woman’s own fat tissue to help reconstruct her breasts.
And it doesn’t stop there. According to the FDA, in most cases, our own cells are drugs too. An FDA panel member even went so far as to state that our blood is an FDA-regulated drug.
For example, if your doctor wants to remove a small sample of bone marrow from your hip and inject part of it into your knee because she has read the literature and believes it can help you heal without surgery, the FDA says that’s verboten because you guessed it – it’s a drug that is subject to the full FDA drug approval process.
As the FDA becomes increasing intrusive in our lives, restricting the ability of licensed medical doctors to practice medicine, one has to wonder where it all will end? The answer seems to be that once the FDA has its way, our bodies, down to the very last cell, will be classified as drugs, and therefore subject to federal regulation by the FDA.
If you agree that the FDA has no business outlawing the use of your own fat tissue to reconstruct your breasts, please spread the word and ask your friends, family members and doctors to let the FDA know what you think before September 27th by commenting here: https://www.regulations.gov/comment?D=FDA-2014-D-1856-0061
You might also consider contacting your local congressman, congresswoman, and state senators.