Filed under: Capitalism, Economy, Health Care, Science/Technology | Tags: Nonsensical Calls, Regulatory Overreach, The Food and Drug Administration
A clinic in Colorado, the Centeno-Schultz Clinic, 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 then re-inject them into the damaged joints. No other drugs are used. The absence of any drugs means that the Food and Drug Administration is not involved, and has no oversight function.
Yes, you guessed it. The FDA has asserted its authority by claiming that your stem cells — the ones your body produces naturally — are in fact drugs and subject to its regulatory oversight. Your stem cells are a controlled substance!
The FDA argues that 1) stem cells are drugs and therefore fall under FDA jurisdiction, and 2) because the clinic is engaging in interstate commerce, they also fall under FDA jurisdiction. The rationale for the “interstate commerce” bit is that out-of-state patients using Regenexx-C would “depress the market for out-of-state-drugs that are approved by the FDA.”
Does that sound like the FDA is protecting the health or American citizens? Or does it sound like the FDA is fiercely defending it’s turf and ability to enforce and regulate? This has been a battle going on for over four years. The FDA is under fire from all sides for the difficulty in getting new drugs approved. It is becoming so difficult that innovators abandon promising candidates. Drugs long approved in other countries must undergo years long investigations here. They are causing shortages of needed drugs for hospitals.
There is a mindset in the regulatory crowd that assumes that wise government bureaucrats are smarter than ordinary people out there, and you ordinary people should shut up and let your betters regulate. The trouble is that there is no evidence whatsoever that government is able to do things better. There are very few things that government is good at, even simple things. There are indeed some things that can only be done by governments — armies and navies, air forces — I was going to add space, but it looks like private enterprise is taking that over. Borrowing — they’re very agile at that — and spending, they set records. But what else? Post Office, nope. The entitlement programs are ridden with fraud, and going broke.
We should expect the federal government to make the case to us — for we are in charge — we the people authorize government activity, why they should be allowed to regulate anything, and demand a better record of good performance.
I’m getting really fed up with this regulatory overreach.
2 Comments so far
Leave a comment