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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