Antibodies are a good example. Anyone know whether blood transfusions
and skin grafts fall under similar regulations?
On Feb 2, 10:10 pm, CodonAUG <elsbe...@gmail.com> wrote:
> Stem cells are biologics and do not fall under the same category as
> small molecule drugs. Similar issues apply to the way antibodies are
> produced and used as drugs. If this kind of wording/loophole is not
> used (and it has to because congress wont change the FDA) then you
> will have a bunch of clinics popping up that use stem cells that are
> not tested for safety and efficacy before being sold.
>
> On Feb 2, 1:54 pm, Bryan Bishop <kanz...@gmail.com> wrote:
>
>
>
>
>
>
>
> > this is a bit editorialized but sad-if-true
>
> > From: Anthony Loera <anth...@revgenetics.com>
> > Date: Thu, Feb 2, 2012 at 2:45 PM
> > Subject: [GRG] Stem Cells Are Drugs - FDA
> > To: Gerontology Research Group <g...@lists.ucla.edu>
>
> > FDA's New Claim: "Your Body Is a Drug—and We Have the Authority to Regulate
> > It!"
>
> > 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:
>
> > 1. 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!)
> > 2. 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<http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion...>
> > ."
>
> > 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<http://www.anh-usa.org/readers-corner-can-physicians-prescribe-drugs-...>,
> > 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<http://www.hpm.com/pdf/blog/GovernmentSupportforSummaryJudgmentMotion...>.
> > 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<http://www.anh-usa.org/readers-corner-can-doctor-get-into-trouble-off...>
> > and part two<http://www.anh-usa.org/why-selling-natural-products-is-such-a-dangero...>
> > ).
>
> > 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<http://espn.go.com/espn/story/_/id/7058209/peyton-manning-last-star-l...>,
> > 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<http://www.huffingtonpost.com/2011/08/22/adult-stem-cells-back-pain_n...>.
> > 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."
> > Article is From:http://www.anh-usa.org/fda-new-claim-body-is-a-drug/
>
> > If this is true, I have issues with it.
>
> > Anthony Loera
> > President
> > RevGenetics
> > (P)888-738-4363
> > (Pl) 305-938-0889 - Local number
> > (F) 866-430-3953
>
> >www.RevGenetics.com
> > FDA Registration: 12631095756
>
> > _______________________________________________
> > GRG mailing list
> > G...@lists.ucla.eduhttp://lists.ucla.edu/cgi-bin/mailman/listinfo/grg
>
> > --
> > - Bryanhttp://heybryan.org/
> > 1512 203 0507
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