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by glial
633 days ago
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I mean, I wouldn't compound drugs for myself for the same reason I don't do maintenance on my car's transmission myself: I don't really know what I'm doing and would probably get myself killed. From what I understand - may be wrong - the 2000x has more to do with IP protections than production safety. |
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By the way, I'm not even sure does IP protections itself apply here. Both parts of this fixed combination drug were known for quite some time (particularly trospium chloride is very old, also often used in research settings). But if they would apply (if the molecule itself was patentable as someone's intellectual property), they would be additional HUGE problem. But what constitutes (or creates) that "2000x" problem here isn't even that, this is most likely the FDA regulations regarding drug approvals and so on, exclusively.
It could be a good idea to wonder about, what if FDA as a governmental agency limited itself to "trusted" information campaigns to the public on efficiency of all medicines, but not doing anything which touches, notably, revenue matters of pharmaceutical companies (as that's why, in my opinion, corporations actually lobby for big FDA influence, they can make more profit off that).
Also, definitely FDA in that model wouldn't be setting themselves as an "authority" for "approvals" of drugs and so on, which for my taste is completely contrary with both the whole putative role of (federal) government, and further, with the Western values (as I outlined in my previous comment) themselves.
That new role and "definition" of FDA would be exactly akin to what NIH is doing even now in the area of nutrition. If you don't know what they do, look at the USDA FoodData Central or all the micronutrient factsheet they publish - it's my go-to resource when I wonder anything about food.
But the FDA role would then be like that, but in regard to man-made substances of medicinal use, as opposed to these occurring in abundance in nature (which, in a great simplification, when they're essential to a human body, we consider "food"). And DEA's complementary role here would be to go after manufacturers who do not label their products according to the truth.