FDA’s New Claim: “Your Body Is a Drug—and We Have the Authority to Regulate It!”
January 31, 2012
In another outrageous power-grab,
FDA 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 over its Regenexx-SD™ procedure, a non-surgical treatment
for people suffering from moderate to severe joint or bone pain
using adult stem cells.
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 to 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.
As 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. No
more 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 the court, 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 company
profits.
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
part two).
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 doing
a 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. The hard
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 treatments. 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 patient’s tissue.
Gov. Rick Perry received this kind of stem cell therapy. We
and 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.”
The Alliance for Natural Health USA
1350 Connecticut Ave NW, 5th Floor, Washington, DC 20036
Ph: 800.230.2762
www.anh-usa.org