When are your own cells considered a “new drug” by the FDA?
That’s a good question.
It appears the Agency considers that your very own cells and tissues need to be regulated as if they were drugs being manufactured in the doctor’s office.
This is wrong and tries to obscure two simple facts:
- Your own cells when used to heal and repair your body are not drugs. Your PRP and stem cells are more like you than anything else in the universe. In fact, these tissues are you.
- The charter of the FDA is to regulate food and medicines, not the practice of medicine.
The FDA issued a proposed Guidance Document for the regulation of cellular and tissue-based products in 1997, and finalized in 2001, in which they state that “[t]he agency would not assert any regulatory control over cells or tissues that are removed from a patient and transplanted back into that patient during a single surgical procedure. The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.” FDA 21 C.F.R. 1271.15
In other words, in 2001, the Agency Position was that there were no health or safety risks that would require them to regulate a patient’s own human cell tissue products (HCT/Ps) as a new drug or device when those HCT/Ps are removed and transplanted back into a patient in the same surgical procedure.
Then 13 years later in 2014, the FDA is narrowed their view of what procedures are exempt from FDA regulation and attempting to expand its regulatory authority over your autologous stem cells. The FDA is position was that a patient’s own tissue products are not exempt from new drug and device regulations “unless the HCT/P is only rinsed, cleaned, sized, or shaped”. In regard to human cells, what exactly does “shaped” mean?
The FDA held hearings that were overwhelmingly in opposition to FDA opinion. The hearings and testimony went on for two days, and experts from universities, clinics, and research groups all provided up-to-date information. Did the FDA listen?
No. In spite of promising that they would revisit and revise their earlier opinion, the FDA proceeded to issue final guidance that is even more restrictive, and touted scientifically ridiculous arguments, including that the only purpose of adipose tissue is to cushion and support, ignoring over 10,000 scientific studies published in PubMed on adipose stem cells and their use in multiple orthopedic and other conditions, and further ignoring the more than 80,000 scientific studies published on the metabolic role of adipose tissue. Really, adipose’s only role is to cushion? Is the FDA stuck in 1920’s research?
Have any health or safety problems with these procedures emerged?
- No public health and safety problem exists.
- In fact, the FDA stated in 2001 that “The communicable disease risks, as well as the safety and effectiveness risks, would generally be no different than those typically associated with surgery.” When responsibly used, no new health risk has emerged in the last 17 years.
- Physicians are trained to perform sterile procedures and the concentrating of human tissues for both diagnostic and treatment purposes has been the practice of medicine for generations.
How are these tissue products used by doctors?
- Because PRP contains your own natural tissue repair compounds, doctors been using it for decades to promote healing and repair in prolotherapy, dentistry, maxillofacial surgery, cardiac surgery, orthopedic medicine and surgery, skin rejuvenation, collagen repair and many other uses.
- Stem cells isolated from a patient’s own adipose tissues have been used for twenty years to safely promote healing and repair in a widening range of human diseases and conditions, including diabetes, COPD, multiple sclerosis, osteoarthritis of the knee and hip, etc.
What is the legal weight of FDA “final guidance’ on doctors?
For now, the FDA has stated that they will continue to review their guidance over the next 3-years, but one can only assume that they held hearings only to satisfy the legal requirement to hold hearings and that they never had any intention of looking at the science. I can only conclude that the FDA wants to expand its charter to regulating the practice of medicine.
- For a more comprehensive analysis by a regulatory attorney, see the following article: Same Surgical Procedure Exception under 21 CFR 1271.15(b): FDA Raises More Questions Than it Answers Regarding the Scope of the Exception
What you can do:
- It turns out that the FDA receives very little in the way of consumer comments, and consumers can have an influence on FDA policies.
- By commenting to the FDA, you will be stated in the public record that as a consumer, you oppose FDA regulations that narrow your access to treatments using your own, autologous cells and tissues.