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Home Front: Politix
According to the FDA, Your Stem Cells Are Now Drugs
2012-02-03
Anyone want an example of how over regulation by the government alphabet agencies is killing business and initiative? Read this.
In recent court filings, the Food and Drug Administration has asserted that stem cells--you know, the ones our bodies produce naturally--are in fact drugs and subject to its regulatory oversight. So does that make me a controlled substance?

The bizarre controversy revolves around the FDA's attempt to regulate the Centeno-Schultz Clinic in Colorado that performs a nonsurgical stem-cell therapy called Regenexx-C. It is designed to treat moderate to severe joint, tendon, ligament, and bone pain using only adult stem cells. Doctors draw your blood, spin it through a centrifuge, extract the stem cells and re-inject them into your damaged joints. It uses no other drugs. No drugs means no FDA oversight and that does not sit well with the administration.
Ok, I can understand some regulations to make sure some quack isn't doing this. So far so good... but wait!
The FDA has since argued that a) stem cells are drugs and b) they fall under FDA regulation because the clinic is engaging in interstate commerce. That's right, a process performed at the clinic using the patient's own bodily fluids constitutes interstate commerce because, according to the administration, out-of-state patients using Regenexx-C would "depress the market for out-of-state drugs that are approved by FDA."
WHA?!?!?
Funny, that sounds less like the FDA protecting the health of the country's citizens and more like the FDA defending its enforcement turf. The two parties have been at odds for over four years now, so we may have a while until we know if every American has in fact become a regulatable good subject to government regulation.
Depress the market for out-of-state drugs!?!? SERIOUSLY!?!? WTF?? IT IS MY OWN GODDAMN CELLS YOU ASSHOLES!!! The FDA has NO business picking drug winners and losers and NONE in interstate commerce!!
Posted by:DarthVader

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