Taking Cannabis-Derived Medications Through the FDA Approval Process - Alice P. Mead, J.D., LL.M.

  Рет қаралды 345

Medicinal Genomics

Medicinal Genomics

5 жыл бұрын

Tags: Cannabis Law, FDA, Pharmaceuticals, Regulations
Ms. Mead, Vice President, U.S. Public Policy and Public Affairs, for Greenwich Biosciences (one of the first companies in the world to develop cannabis-derived medications as prescription products in adherence to modern scientific and regulatory standards for pharmaceutical products), discusses how the challenges of securing approval from the Food & Drug Association (FDA) are even greater for products derived from botanical materials.

Пікірлер: 2
@ganjatrain2324
@ganjatrain2324 5 жыл бұрын
legalize now!
@davidfooterman6515
@davidfooterman6515 4 жыл бұрын
The process is far too complicated. The question is how much of it can be reserved for xenobiotic substances and dropped from the requirements for a natural extract. This is a very complex problem. Maybe we will leapfrog over it by creating genomic reference data of the type presented by Kevin McKernan. Once his and other groups are able to declare clean, accurate and reproducible clades with which to develop reliable seed genetics, the FDA might have the basis for a new approach to licensing specific seed genetics and defining the growing criteria necessary to keep the genomics constant. I am trying to visualize this process with my limited knowledge and understanding. It seems to me that the above is years away from a reality, BUT cannabis could end up being the catalyst for an entirely new FDA system of what I would call "prescription pharmacognosy". Medical scientists know what these two words mean but you don't see them joined together in one phrase. We could be harnessing the massive power of millions of years of phytochemical co-evolution, primarily the 400 million year arms race between plants and insects by the way, to make many relatively safe, non-toxic plant products. In order to do this, we must reform patent law to allow pharmaceutical companies to access natural chemicals for profit instead of being forced to tweak them into xenobiosis, and then having to do a billion dollar phased R & D to quantify their reduced efficacy and increased toxicity. It amazes me how much money is spent on trying to isolate one exciting chemical from a plant or animal mixture found to treat, say cancer, in the hope of getting the next wonder drug. For example, why can't we grow and prescribe individual or combined broccoli sprouts and other cruciferous plant extracts instead of spending millions on developing and testing one or two isothiocyanates that we think are responsible for everything we saw. No pharmaceutical scientist with a deep understanding of the subject would have the hubris to debate the proposition that we can lab-tweak better in a few years than Mother Nature can mutate and test by trial and error through natural selection over millions of years. It would be a ridiculous assertion: government needs to think on this and invest very serious dollars in a new development system of prescription pharmacognosy for our future. Wow, I enjoyed the rant, even if nobody gets to read it.
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