Today’s FDA: Your Cells are Drugs and your Private Life is our Biz!

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your cells are drugs

You’ve likely read about the FDA’s bid to regulate your body the same as a drug factory – something we call cells=drugs, or your cells are drugs.  While there are a number of endemic and procedural problems that lead to this concept that the cells in your body can be classified the same as a prescription drug, one of the main sticking points is the FDA’s tendency to apply it’s regulations where they don’t belong or even make common sense. In this case, the issue is categorizing what happens between you and your doctor the same as a drug factory pumping out millions of doses of drugs for mass distribution. This obviously makes no common sense, nor is it supported by sound public health policy, nor by any legal history, nor by any authority granted by congress. What’s next from the FDA? A patient sent me an article this week that I just had to share, because it now moves the FDA regulated line into the world of consenting adults. Basically, a San Francisco woman is suing the FDA because she tried to arrange for her own sperm donor. This woman says she wants to use a man she trusts as the donor – makes common sense. Not so fast, says the FDA, who doesn’t differentiate between this woman and a large scale fertility clinic or hospital, so the woman will have to follow the same cellar based guidelines for donor screening as the clinic. What does this mean? The FDA doesn’t regulate the medical procedure known as in-vitro fertilization – that’s practice of medicine. Even if they culture or extensively manipulate the cells, it’s still practice of medicine. However, they do now require these clinics to screen sperm donors for infectious diseases, like you would screen a kidney or a heart before transplantation. So this woman must pay for the same expensive donor screening and be subject to inspection like these clinics and hospitals. These tests can run thousands of dollars and in sperm banks can be spread across many samples used in patients. This habit of FDA to blindly apply regulations without common sense is very concerning. Obviously, this woman can become infected with any number of infectious diseases if she gets pregnant the traditional way-through intercourse. The FDA tried to do the same thing recently to small family farms growing organic foods by writing laws that would apply regulations meant for massive agri-businesses to these local operations. Given the limited spread of contamination in a small organic farm, their industry group finally defeated the measure. Good thing, a $10 organic apple anyone? The upshot? We have an FDA that’s out of control and not using common sense. If they have a regulation on the books, it applies to the massive business they are charted to regulate in addition to your body and your personal life. What’s next, our breakfast cereal is a drug? Oops, that one really happened… Maybe next they’ll call…oh I don’t know, Walnuts drugs? Oh, um, that happened too. OK, I give up…

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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