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Biotech Government Medicine United States

FDA Regulating Your Stem Cells As Interstate Commerce 332

New submitter dcbrianw writes "A non-surgical procedure that treats joint pain involves removing stem cells from a patient's blood and reinserting them into the joint. The facility conducting these procedures resides in Colorado, but because it orders equipment to perform the procedure from outside of Colorado, the FDA claims it must regulate this process and that it can classify stem cells as a drug. This issue opens the debate of what the FDA, or other regulatory bodies, may regulate within each of our own bodies." Quick: Name five activities with no possible plausible effect on interstate commerce.
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FDA Regulating Your Stem Cells As Interstate Commerce

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  • by Hijacked Public ( 999535 ) on Thursday February 02, 2012 @05:49PM (#38908363)

    No it isn't.

    The 'potentially biohazardous material' is contained inside the patient when he boards the airplane to fly to Colorado. That he happens to be going to Colorado to have this procedure performed sets him aparts from the other airplane passengers not at all.

    What the FDA is claiming and will probably be backed up by the executive on but possibly not the judicial, is that because the company performing the procedure purchases equipment from other states, their entire business can then be regulated per the commerce clause. This includes their performing the procedure.

    It is the same line of thought that had the Clinton administration claiming it could confiscate a person's property simply because that property had once moved across state lines, no matter how long ago and no matter how many hands it had previously passed through, even within the same state. This is an enormous power to give to a government and the very idea that such a tenuous tie is enough to warrant it is insane. SCOTUS rebuked that just a bit recently, but not nearly enough.

  • by aklinux ( 1318095 ) on Thursday February 02, 2012 @06:57PM (#38909287) Homepage
    I suppose this means that now I will need FDA approval before inserting sperm into a womans body?
  • by pesho ( 843750 ) on Thursday February 02, 2012 @07:32PM (#38909755)

    This is a moronic summary of a stupid article. This is not about FDA regulating your stem cells, it is about FDA regulating snake oil salesmen, before somebody gets hurt.

    Some schmuck finds a loophole in the law that allows him to perform for profit untested medical procedures with questionable (to put it mildly) outcome. FDA has two options:

    1. Ignore him and when somebody gets hurt get dragged to congress as a showpiece of a useless government bureaucracy.

    2. Cover their bases and use all (no mater how questionable) authority that it can muster to try to shut him down.

    Option one is a loosing proposition. Option two is a win-win no-matter how the court decides. If the court allows this to fly (unlikely) they win. If the court laughs at their arguments (more likely) they have covered their asses big time. Now they can turn to congress and say 'We have done what we can, it is your turn now to decide if this should be regulated'. In addition, at any point in the future when a similar situation pops up they are absolved from responsibility.

  • by Rich0 ( 548339 ) on Thursday February 02, 2012 @08:33PM (#38910351) Homepage

    Well, alas a majority of your fellow Americans wanted the right to wait until they were sick to buy health insurance.

    It didn't help that quite a few insurance companies claimed that people were doing this when they actually weren't.

    So, because both individuals and companies like to scam each other we now have a compromise where companies have to offer insurance to anybody (even if they're already sick), and individuals have to buy insurance even if they don't think they will get sick.

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