Start with a simple, basic drug that has been used for over 2500 years, was brought to America by Benjamin Franklin and cost about $7 for a three-week supply. A drug which pre-dated the FDA, which meant it was grandfathered. Add in a government which says that anything not approved by the government must automatically be suspect, toss in a cooperative drug company. What do you get? A drug than now costs $185 for a three week supply. Nothing changed at all except that it now has FDA certification. Oh, and the price, of course. Feel free to read the article yourself, and see what I’m talking about.
The truly scary part of this is the statement by the FDA (as I noted above):
FDA official Deborah Autor spoke to CBS News as head of the office of unapproved drugs. “Well, for me, unapproved drugs present current risks,” Autor said. “We don’t know what’s in them. We don’t know if they’re going to work properly. We don’t know how they’re made and that’s a real concern.”
Note well that this drug has been on the market for 100 years, has been prescribed by medical practitioners (all of them licensed by the government, mind you), and was effective. Yet, the FDA calls it a risk. Why? Because they didn’t approve it. Don’t use the drug in question? I bet you might use another one that is just as old, far more commonly used and certainly predates the FDA, given that it was first use 350BC! What drug am I talking about? Aspirin. It currently costs pennies per dose, and is widely available in many forms and brands, and is added to other over-the-counter drugs. If some company were to follow the same program for aspirin as URL Pharma did, there is a chance that aspirin might not be approved, and if it were approved, that the cost would go from pennies a dose to a dollar or more a dose.
Think this is hyperbole? Think again. The FDA has a program that will effectively eliminate all non-approved drugs, including grandfathered drugs from the market. Think aspirin can escape? Nope. The FDA regulations say that it is illegally grandfathered! Why? Because even a change in the label is sufficient to disqualify it! Note well—the drug does not have to change, just the package! That’s insane.
Does anyone really believe (besides the big-government, control-freak types) that government approval somehow makes Colchicine better? Or that it would improve the safety or efficacy of aspirin? These compounds have been used for 2500+ years because they work. Government help wasn’t needed to create, test or improve them, or determine the correct doses. That was done by doctors and their patients over the course of centuries.
The result of this government control freakery? Higher prices, lower availability, rent-seeking (URL Pharma sued all other producers of Colchicine to get it off the market), and no added benefits. Once again, we see regulations that have seriously perverse effects while adding no value at all. The FDA has no supervision, answers to nobody (well, in theory to Congress, but they aren’t going to override any decisions made by the FDA) and has plenipotentiary power to approve, ban or otherwise control drugs. This uncontrolled, unlimited power is a threat to liberty, to heath and to the consent of the governed. At least in this case, the government did not have the best interests of the people who use this drug in mind. Only their own power to control that usage. Quis custodiet ipsos custodes indeed.
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