Marty Makary
speaker
939 appearances
6 recordings
5 series
first heard Jan 2026
last heard 13 May
Marty Makary’s voice in public audio — every appearance, attributed to the second.
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recordings per month · last 12 monthsRecordings per month over the last 12 months — 6 in all, peaking in Jan 2026 with 4.
Appearances
So a drug developer or an inventor can go and see exactly why a drug was accepted or rejected and see the logic of the review team.
It's going to help innovators understand the system better so it's not a black box.
It's also going to keep companies more accountable because right now they spin FDA decisions to their shareholders.
Number one is our regulation of AI software, that is, AI in digital health devices or in an artificial pancreas, for example.
Generally speaking...
Our regulation of AI technology has been entirely broken.
I mean, we have been writing on stone tablets.
We don't even understand some of the AI that's out there.
We can't possibly outrun this lion to safeguard the public.
We can't say, well, we're not going to allow chat GPT unless we can ensure that every possible health question is going to give you a perfectly safe answer.
And so we've got to modernize our regulation of AI technology.
First of all, we are getting things done in record time.
Most of the stuff we've done, including, for example, make our decision letters public, that has been tried here at the agency for 40 years.
We got it done in months.
Why wasn't it able to be done?
For the reasons you said.
It was lawyers and objection and the bureaucracies.
And so we convene people, we make sure everything we do is lawful, and we get things done.
Same with AI for our scientific reviewers.
We should not have this paternalistic approach that, oh, we can't let our scientific reviewers at the FDA use Google because there could be a hit that could be inaccurate.
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