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This is the Kator Daily Podcast for Monday, December 10th, 2018.

I'm Caleb Brown.

The FDA's pursuit of safety puts patients willing to take on more risk

at a potentially fatal disadvantage. Mark Flatten is the National Investigative

reporter at the Goldwater Institute. We spoke in November about what he calls the deadly consequences

of FDA's over caution.

You argue that the regulatory process at the FDA for new drugs is broken and it's sort of just this patchwork of

pieces of regulation that have been altered and tweaked over time. What is the single biggest problem

with FDA's regulatory process for approving new drugs?

Well, the single biggest problem at the FDA

is really risk aversion.

FDA regulators know that if they,

their biggest fear is that they'll approve a drug that's later

going to come out to have some unseen side effect.

And so in their quest for sort of absolute statistical certainty,

they've added more testing requirements, more tests, more time, more delays, and frankly more cost.

...