Mark Raby, Feb 1st 2012
In what is perhaps one of the most controversial cases the Food and Drug Administration has ever participated in, there’s a new argument that’s making some pretty heavy waves. In essence, the FDA says that a person’s individual body can be categorized as a “drug” and is thus subject to all the government-mandated regulations about interstate commerce and the like. That’s the meta-level, theoretical interpretation so let’s take a look at the specific case that has led to this wild claim.
At issue is a Colorado clinic which performs a non-surgical treatment called Regenexx-SD. It’s used for patients who have joint or bone pain, and the process involves using adult stem cells. Other than that, no drugs are used so the clinic has been operating without the stringent restrictions in place by the FDA. But now the FDA is arguing that stem cells, which exist in every living human, are drugs and thus subject to government regulation.
What is particularly cumbersome for the clinic is if the FDA has authority over the procedure, it has to be classified as interstate commerce, which ends up causing a lot of bureaucratic hullabaloo. The next step here is in court, where it will actually be up to the judicial process to decide whether or not something that resides in every human being can be subject to government intervention. How does that make you feel?