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 months
4 · Jan OctJan 26AprJulnow

Recordings per month over the last 12 months — 6 in all, peaking in Jan 2026 with 4.

Appearances

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And we're doing it through creative ways.
It's not historically the domain of the FDA, but because the health agency heads, that is the head of the Center for Medicare and Medicaid Services.
That's Mehmet Oz.
Yeah, Oz and Jay Bhattacharyya at the NIH, because we work very closely together and talk a lot with the Secretary of Health, we actually come up with ways to lower health care costs together in synchrony.
Yeah, that's a good example.
At the FDA, we're telling companies that if they promise to provide prices comparable with other developed nations around the world, that is, give us the best price.
then we'll give them priority in the review, and a voucher to get a priority in review has a street value of $500 million, roughly.
So we're using market incentives, essentially, to create incentives for companies to lower their prices.
Well, we have two problems.
One is overregulation and the other is underregulation.
But by far, the problem of overregulation and regulatory creep dominates the business of the FDA and its interface with the U.S.
economy.
It's my opinion that we could engage in more deregulatory policies, cut the red tape, and challenge the assumption that it takes 10 to 12 years for a new drug to come to market.
If you have the cure for breast cancer, it does not make sense to me that we put you through a long, arduous process that takes that long when we can probably make basic assessments on safety in a year or two.
Well, it started off where a scientific reviewer or two would be assigned a file, and they would work with a company to ensure that they went through the appropriate steps of doing a preclinical set of studies to then move on to a phase one trial, and then phase two, and then phase three, and then review the final application.
But now the applications have gotten so gnarly, they can be over 100,000 pages because the FDA wants to see this and they want to see that.
And the companies have got into this arms race by saying, we don't want any gotchas to slow down the application.
Let's just throw the kitchen sink of every single data point we have.
And then the FDA says, well, then we need more reviewers to
to review these applications.
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