According to the FDA, Your Stem Cells Are Now Drugs
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.
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."
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. [ANH-USA via Slash Gear]
