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criley2 · 2017-05-15 · Original thread
It's not farfetched in the least to have one entity approve the drugs based on roughly $1 billion dollars over 10 years[1] worth of research.

What's more farfetched to me is allowing private, profit-motivated corporations the unfettered ability to produce this expensive research.

Fortunately the all-but-oppressive regulation of the FDA from GLP and GMP to insanely rigorous science-based four phase system of testing is IMO the greatest achievement in science-based regulation in human history.

People simple do not understand or respect the awesome power of the scientific method being the basis of government regulation.

[1] http://onlinelibrary.wiley.com/doi/10.1002/9780470403587.ch1...

or go to https://www.amazon.com/Drugs-Discovery-Approval-Rick-Ng/dp/0... and use the "look inside" feature to see page 4: "It is estimated that, on average, a drug takes 10-12 years from initial research to reach the commercialization stage. The cost of this process is estimated to be over $1 billion USD" (2005)

Another fun tidbit you'll find in the book: On average, for every 10,000 NME's that begin research, 1 NME will receive FDA approval. (where NME is a new molecular entity, a novel new drug).

So you've got a market where you have to begin development on 10,000 products to get 1 product into the market, on a 10 year runway. Could you imagine that in tech? 9,999 pivots per product!

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