According to the FDA, Your Stem Cells Are Now Drugs

Illustration for article titled 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?

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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]

Image via the AP

DISCUSSION

sammybaby
sammy baby

Disclaimer: I work for a company which produces clinical software and medical devices, most of which are regulated by the FDA.

So, um. You guys are aware that some things that are _explicitly_ not drugs - like, say clinical software and medical devices - are also regulated by the FDA?

I mean, the FDA has been regulating hormone replacement therapy for years, including when actual human hormones (as opposed to synthetics) are used. Are hormones, of the type your body naturally produces, drugs?

The FDA also regulates blood and blood products used in transfusions. Last I checked, nobody on Giz was freaking out that the government claiming to be able to regulate their own blood (hint: autotransfusion is a real thing, and if you think that the FDA doesn't regulate that, you're out of your minds).

Nobody argues that computer software is a drug, last I checked. But I've worked on software which sends and receives medical imagery and radiation dosage information, and unless you're interested in seeing a Therac-25 Mark 2 built somewhere, you'd probably like to see some oversight of those devices.

Look, I get it, the FDA is a big government agency. It sometimes does its job badly, and it's prone to corruption and abuse in the same ways that all other large government agencies are, and for that they deserve careful oversight. But the FDA is also the reason that it's illegal for a doctor to inject Fix-a-Flat into your ass, so maybe we try to keep things in perspective, okay?