Like, if you could just sell arbitrary prescription drugs as nutritional supplements by simply making no claims about what they do, surely people would be doing so?
I don't think anybody's saying you can just sell arbitrary prescription drugs as nutritional supplements: first of all, there's patent law for synthetic (synthesized) drugs, and I don't know how it applies, if at all, to nutritional supplements. I don't think you could synthesize a brand-name, patented drug and put it in capsules and sell it as a nutritional supplement, because, if nothing else, the patent-holder's lawyers would hunt you down and ruin your decade. It's only if your synthesized compound has a natural source that you wind up with it also being available as a supplement.
The case of red yeast rice/lovastatin I think locates the problem in the definition of "is". As I understand it - which is weakly - the microbe that makes red yeast rice red was one of the microbes studied in the drug discovery process of lovastatin, which was then synthesized in the lab. The synthesized compound was put through FDA approval as a drug, but red yeast rice, itself, was not. So despite red yeast rice being a natural source of lovastatin, red yeast rice "is" something different from lovastatin and wasn't ruled a drug, and stayed in the nutritional supplements classification.
Second, I expect once a drug has been classified as a drug by the FDA, they regulate it as such. Aripiprazole is now available in generic, so no more patent, but that doesn't mean that you can put it in capsules and sell it as a nutritional supplement.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
Add to this the fact that the FDA regulates marketing in a way that goes beyond patents, such that the owner of something FDA classified as drug has strong advantages in the market.
Second, I expect once a drug has been classified as a drug by the FDA, they regulate it as such. Aripiprazole is now available in generic, so no more patent, but that doesn't mean that you can put it in capsules and sell it as a nutritional supplement.
Right, there is at least some classifying of substances as drugs, as opposed to pure packaging regulation; hence the need to actually get a prescription to obtain certain drugs.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
I don't think anybody's saying you can just sell arbitrary prescription drugs as nutritional supplements: first of all, there's patent law for synthetic (synthesized) drugs, and I don't know how it applies, if at all, to nutritional supplements. I don't think you could synthesize a brand-name, patented drug and put it in capsules and sell it as a nutritional supplement, because, if nothing else, the patent-holder's lawyers would hunt you down and ruin your decade. It's only if your synthesized compound has a natural source that you wind up with it also being available as a supplement.
The case of red yeast rice/lovastatin I think locates the problem in the definition of "is". As I understand it - which is weakly - the microbe that makes red yeast rice red was one of the microbes studied in the drug discovery process of lovastatin, which was then synthesized in the lab. The synthesized compound was put through FDA approval as a drug, but red yeast rice, itself, was not. So despite red yeast rice being a natural source of lovastatin, red yeast rice "is" something different from lovastatin and wasn't ruled a drug, and stayed in the nutritional supplements classification.
But! See https://en.wikipedia.org/wiki/Red_yeast_rice#Regulatory_restrictions : The FDA eventually got around to cracking down on "red yeast rice extract" nutritional supplements as having lovastatin in them, and therefore being a drug.
Second, I expect once a drug has been classified as a drug by the FDA, they regulate it as such. Aripiprazole is now available in generic, so no more patent, but that doesn't mean that you can put it in capsules and sell it as a nutritional supplement.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
Add to this the fact that the FDA regulates marketing in a way that goes beyond patents, such that the owner of something FDA classified as drug has strong advantages in the market.
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Right, there is at least some classifying of substances as drugs, as opposed to pure packaging regulation; hence the need to actually get a prescription to obtain certain drugs.
But this all raises the question as to whether there are quiet discussions going on in boardrooms at drug discovery companies, asking whether they might do better by making an end-run around FDA approval and going right to market with a "supplement".
Huh -- interesting question...
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