January 31, 2012
In another outrageous power-grab,
says your own stem cells are drugs - and stem cell therapy is
interstate commerce because it affects the bottom line of
FDA-approved drugs in other states!
We wish this were a joke, but it’s the US Food and Drug
Administration’s latest claim in its battle with a Colorado clinic
Regenexx-SD™ procedure, a non-surgical treatment for people
suffering from moderate to severe joint or bone pain using adult
The FDA asserts in a court document that it has the right to
regulate the Centeno-Schultz Clinic for two reasons:
Stem cells are drugs and therefore fall within their jurisdiction.
(The clinic argues that stem cell therapy is the practice of
medicine and is therefore not within the FDA’s jurisdiction!)
The clinic is engaging in interstate commerce and is therefore
subject to FDA regulation because any part of the machine or
procedure that originates outside Colorado becomes interstate
commerce once it enters the state.
Moreover, interstate commerce is
substantially affected because individuals traveling to Colorado
have the Regenexx procedure would,
“depress the market for
out-of-state drugs that are approved by FDA.”
We discussed the very ambiguous issue of
interstate commerce last
September - it’s an argument the FDA frequently uses when the basis
for their claim is otherwise lacking.
we noted then, the FDA
holds that an “interstate commerce” test must be applied to all
steps in a product’s manufacture, packaging, and distribution. This
means that if any ingredient or tool used in the procedure in
question was purchased out of state, the FDA would in its view have
jurisdiction, just as they would if the final product had traveled
across state lines.
This time the FDA just nakedly says in court documents that the
agency wants to protect the market for FDA-approved drugs.
beating around the bush - their agenda is right out in the open!
This appears to be a novel interpretation of the Food Drug and
Cosmetic Act (FD&C), as evidenced by the government’s failure to
cite any judicial precedent for their argument.
The implication of the FDA’s interpretation of the law, if upheld by
would mean that all food, drugs, devices, and biologic or
cosmetic products would be subject to FDA jurisdiction. The FDA is
expanding its reach even to commerce within the state, which we
argue is far beyond its jurisdiction, in order to protect drug
Last year we ran a two-part series on the current status of federal
and state law - and FDA jurisdiction - and how it affects
integrative treatments (part one and
The Centeno-Schultz Clinic takes your blood, puts it into a
centrifuge machine that separates the stem cells, and a doctor puts
them back in your body where there is damaged tissue.
The clinic has
argued numerous times that stem cells aren’t drugs because they are
components of the patient’s blood from his or her own body.
The FDA says otherwise:
“Stem cells, like other medical products
that are intended to treat, cure, or prevent disease, generally
require FDA approval before they can be marketed. At this time,
there are no licensed stem cell treatments.”
There they go again,
saying that components of your body are drugs and they have the
'authority' to regulate them! It’s the only way the agency can claim
that adult stem cell therapy is within FDA’s purview.
However, the agency seems to be of two minds.
When ESPN magazine was
story on stem cell treatments, the FDA stated that US policy
is to allow the injection of stem cells that are treated with,
“minimal manipulation,” which federal regulations define as
“processing that does not alter the relevant biological
characteristics of cells or tissues”,
...which is certainly the case
with the Regenexx clinic.
Despite this policy, FDA has been attacking the clinic for the past
four years. They have tried injunctions and demanded inspections in
their attempts to make the company bend; this court battle is merely
the latest salvo.
The primary role of adult stem cells in a living organism is to
maintain and repair the tissue in which they are found.
part has been to get enough of them. But new technology is giving
doctors the ability to obtain more stem cells from a patient than
previously thought possible, which is why we’re now seeing new
Blood, fat, or tissue is withdrawn from the patient,
stem cells are obtained using one of these new processes, and the
cells are injected back into the patient where they can repair the
Gov. Rick Perry
received this kind of stem cell therapy.
others noted that the governor’s defense of freedom of healthcare
choice when it came to his own treatment was starkly at odds with
his directive to administer HPV vaccines to young girls against
their own (and their parents’) wishes. It’s also at odds with his
support for some of the most egregious witch-hunters on the Texas
State Medical Board, which he appoints.
Behind Perry’s blatant inconsistency and the latest FDA attempted
power grab lies the same problem:
a medical system run by special
interests under the leadership of the US government, the same
government that is supposed to represent “we the people.”