The Food and Drug Administration asserts authority over your body, because it is a chemical factory. We wouldn’t want to see 300 million unregulated factories wandering around, would we? Of course not.
Consider stem cell research. What if a company found a way to extract chemicals from your body (called bone marrow) to treat your body for cancer? Well, we know what would happen next. You would be tempted to start selling unregulated bone marrow. Or some profit-seeking third party might. So, the FDA has taken steps to nip this in the bud.
It has brought action against a private laboratory that supplies bone marrow to people — bone marrow taken from their own bodies.
No, you may be thinking. This is Alice in Wonderland. This is an asylum run by the inmates.
The Food and Drug Administration (FDA) has gone to court to prevent the Colorado-based firm Regenerative Sciences from using stem cells developed in one part of your body (bone marrow) to repair damage in other parts of your body, such as joints. The FDA objects to the fact that these cells are chemicals, the use of which they have the power to regulate even though the cells are taken from your body to later be injected back into your body.The FDA is accustomed to the process by which it requires that many years and millions of dollars be spent to approve drugs developed in a laboratory before anyone is allowed to use them. Regardless of clinical results that show use of stem cells to be highly effective, the FDA finds it intolerable to let you use the cells in your own body without prior approval by a vast and expensive bureaucracy.
The FDA is clear: it is in charge of your body. You aren’t.
This is North’s first law of bureaucracy in action. What is North’s first law? This: “Eventually, some bureaucrat will enforce a rule literally to the point of insanity.”
Will the FDA get away with this? Probably. Who will challenge it? Who can afford to challenge it?
Maybe a public interest law firm will come to the rescue. But there are many bureaucrats and few public interest law firms.
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This was posted on May 22, 2012. The original is here.
The government sued the company. The government won in a district court. There is a Wikipedia entry on this: https://en.wikipedia.org/wiki/United_States_v._Regenerative_Sciences,_LLC.
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