Found in 1 comment on Hacker News
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.


or go to 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!

Fresh book recommendations delivered straight to your inbox every Thursday.