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Speaker 1: Welcome to Wellness on Mass.

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Speaker 2: I'm doctor Nicole Sapphire, where we peel back the headlines

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Speaker 2: and uncover what's really happening.

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Speaker 1: In the world of health and medicine.

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Speaker 2: I'm joined by someone today who needs little introduction, doctor

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Speaker 2: Marty McCarey, who's now serving as the Commissioner of the FDA.

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Speaker 2: We are going to talk about his vision for the agency,

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Speaker 2: what changes may be on the horizon, and how the

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Speaker 2: FDA plans to strike a better balance between innovation, safety

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Speaker 2: and transparency.

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Speaker 1: And now we're not just going.

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Speaker 2: To talk to him about the missteps that occurred during

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Speaker 2: COVID and how the vaccines and the COVID boosters were

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Speaker 2: continuously recommended into perpetuity without new data. We are also

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Speaker 2: going to talk about the expedited approvals of the GLP

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Speaker 2: ones where it comes to weight loss. Are too many

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Speaker 2: people using them? Do we even have safety data? And

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Speaker 2: what decisions the FDA are going to make about these medications.

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Speaker 2: I also want to ask him about American small businesses

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Speaker 2: who are being crushed under the FDA. We're specifically talking

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Speaker 2: about the hygiene, cosmetic, and wellness industries. Did you realize

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Speaker 2: that if you have a small business owner here in

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Speaker 2: the United States making an organic shampoo and conditioner, they're

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Speaker 2: subjected to costly testing, stringent guidelines, and also subject to

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Speaker 2: consistent inspections.

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Speaker 1: Where if you look to China.

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Speaker 2: The companies that are making cheap shampoo and conditioner are

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Speaker 2: able to sell it for cheap because they are not

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Speaker 2: under the same rules as the FDA. Why not Americans

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Speaker 2: are consuming those as well? Why is it not fair

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Speaker 2: to the American small business owner? This goes completely against

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Speaker 2: the America First agenda, So I want to ask doctor

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Speaker 2: McCarry about that as well. More coming up on Wellness

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Speaker 2: Unmasked with doctor Nicole Sapphire. All right, well, we're extremely

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Speaker 2: excited to have the new FDA commissioner, my friend and

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Speaker 2: former colleague, doctor Marty McCarey join us today on Wellness Unmasked. Marty,

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Speaker 2: let's talk about the FDA. In your view, how's it

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Speaker 2: been going the last four to five years.

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Speaker 3: To evaluate how the FDA has done in its history.

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Speaker 3: I would say it is parallel to what the medical

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Speaker 3: establishment has done in its history, and that is, there

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Speaker 3: have been shining moments and there have been embarrassing moments

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Speaker 3: like OxyContin and yox and Mechina, And so the FDA

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Speaker 3: I think does best when we are incredibly transparent, when

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Speaker 3: we're humble, when we're open and honest about our mission

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Speaker 3: to safeguard the public and at the same time or

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Speaker 3: promote innovation. There are parts of the FDA that run really,

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Speaker 3: really well. There are parts of the FDA that are

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Speaker 3: very bureaucratic, and so we're trying to ask the big

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Speaker 3: questions that have never been asked before. Why does it

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Speaker 3: take ten years for a new drug to come to market?

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Speaker 3: Why do forty percent of our nation's children now have

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Speaker 3: a chronic disease and you don't see those numbers in

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Speaker 3: other countries.

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Speaker 4: What can we do to create a great.

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Speaker 3: Workplace environment, to make an attractive place to work? So

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Speaker 3: that's my focus as I walk into this role.

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Speaker 4: Now. I think I've been here for about.

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Speaker 3: Eight weeks or so, but those are some of the

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Speaker 3: questions that I'm exploring with the folks here.

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Speaker 2: Well, something else that you've been doing that's made some

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Speaker 2: very recent headlines is that you're also demanding more data

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Speaker 2: when it comes to specifically COVID vaccines. The CDC can

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Speaker 2: remove the COVID vaccine from its routine immunization schedule for

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Speaker 2: healthy children. This came in a parallel time where you

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Speaker 2: were demanding that the pharmaceutical companies also provide more updated

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Speaker 2: data regarding healthy children and repeated COVID vaccines. But here's

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Speaker 2: my question, Marty, many parents physicians want to know. You know,

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Speaker 2: what was that decision based on. Was it compelling new

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Speaker 2: safety or efficacy data or was it just a tacit

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Speaker 2: admission that maybe the original data, you know, the justification

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Speaker 2: for putting it on the schedule in.

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Speaker 1: The first place, was weak, flawed, or non existent.

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Speaker 3: Yeah, so we don't have the data to support the

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Speaker 3: repeat booster strategy in perpetuity forever. That was a theory

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Speaker 3: that a young, healthy child should get a COVID booster

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Speaker 3: every year for their entire life, which would mean a

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Speaker 3: baby girl born today would get eighty COVID shots in

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Speaker 3: her average eighty year lifespan. And so that is a

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Speaker 3: theory that is unproven. We don't know if it's necessary.

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Speaker 3: We haven't fully assessed the harms of mRNA. We hear

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Speaker 3: of hundreds of thousands of individuals who have described injury

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Speaker 3: from the vaccine. There have been deaths from the vaccine,

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Speaker 3: and so people are wondering if the risk benefit ratio

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Speaker 3: favors a repeat booster in infinity. And so that's where

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Speaker 3: we have said, it's been about four years since we've

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Speaker 3: had randomized control trial data on the COVID shots and

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Speaker 3: the boosters, and it now is a different virus, it

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Speaker 3: behaves differently, and there's a large proportion of Americans that

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Speaker 3: have natural immunity or population immunity.

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Speaker 4: So how do we answer that question?

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Speaker 3: Honestly, for the twelve year old girl who comes in

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Speaker 3: and has already had five COVID shots, can we really

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Speaker 3: say that they need it? I mean, can we really

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Speaker 3: use that term in the absence of data? So I think, look,

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Speaker 3: we're taking an evidence based approach now on vaccines and

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Speaker 3: on the COVID shots, and so we published in the

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Speaker 3: New England Journal of Medicine and Evidence Based Strategy, which

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Speaker 3: brings us back to the gold standard of science where

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Speaker 3: we'll have clinical trial data to support. I just don't

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Speaker 3: think we should put on the blinders and blindly rubber

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Speaker 3: stamp COVID shots for young, healthy children in perpetuity. I

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Speaker 3: think we should get back to an evidence based approach.

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Speaker 2: Well, you and I have been a lockstep with that

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Speaker 2: I think, you know, I was rage, texting and email

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Speaker 2: telling you you know, all throughout the COVID pandemic, specifically

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Speaker 2: when it started to be the universal recommendation was that

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Speaker 2: children get the vaccines, and then we saw the mandates

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Speaker 2: and then even the boosters came out.

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Speaker 4: You know.

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Speaker 2: The concern that I had as a parent and as

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Speaker 2: a physician was that we started hearing from the Israeli

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Speaker 2: public Health that there were safety signals, specifically milcarditis or

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Speaker 2: heart inflammation in young men, young adolescents, and yet we

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Speaker 2: even started seeing rising cases in our vears or that

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Speaker 2: self reported database. Now, I know we don't necessarily do

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Speaker 2: policy over anecdotes, but how come they continued to be

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Speaker 2: you know, year after year, continued to get that rubber

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Speaker 2: stamp under the Emergency Use Authorization, and like clockwork ASIP,

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Speaker 2: you know, the CDC's Advisory committee continued to recommend them.

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Speaker 1: Without new data, but there was clearly.

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Speaker 2: Safety signals going on. What do you think led to

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Speaker 2: really the absence of data the last few years that

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Speaker 2: you are now finally starting to demand.

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Speaker 3: You know, there has been a sort of strong culture

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Speaker 3: of pattern, and you've seen it in some of the

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Speaker 3: minutes of the past ASIP meetings on the COVID booster

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Speaker 3: for young healthy children. I wrote a piece titled why

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Speaker 3: Americans Don't trust the CDC and specifically cited the minutes

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Speaker 3: of some of those ACP meetings a couple of years ago,

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Speaker 3: where they were basically saying, we need a streamlined message.

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Speaker 3: People will be confused if we have a risk stratified approached.

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Speaker 3: That is a nuanced approach treating a sixty five year

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Speaker 3: old with a comorbidity different from a young, healthy, nineteen

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Speaker 3: year old boy. And the truth is that we've never

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Speaker 3: really gotten great data on the myocarditis risk. Some studies

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Speaker 3: have suggested that the risk is greater than one in

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Speaker 3: three thousand young boys after the second dose of one

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Speaker 3: of the vaccines.

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Speaker 4: Now that means tens of thousands of boys.

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Speaker 3: Have been affected by myocarditis, and some studies have shown

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Speaker 3: that a third those cases result in scarring, which may

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Speaker 3: be permanent, it's maybe a long term sequala.

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Speaker 4: So you have to take things seriously. You got to

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Speaker 4: use good data.

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Speaker 3: If you don't use good data and you're not capturing

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Speaker 3: complication rates with good methodology, you make the vaccine look

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Speaker 3: safer that it really is. And if you don't distinguish

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Speaker 3: incidental COVID hospitalizations from hospitalizations for COVID.

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Speaker 2: We were dealing with, you know, we were not getting

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Speaker 2: the full picture when it came to the numbers. It

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Speaker 2: was not accurate whether someone was you know, we've said

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Speaker 2: many times admitted with COVID or for COVID. I think

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Speaker 2: in the updated application to the FDA from Maderna for

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Speaker 2: their updated booster though, they cited that by ninety days

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Speaker 2: those who had vaccine induced mildcarditis, when they looked at

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Speaker 2: the past data, there was still symptomatic. And so that's

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Speaker 2: concerning because the talking points when you were turning on

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Speaker 2: the TV, you would say, oh, it's just transient, everyone's

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Speaker 2: back to normal. But at no point should we just

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Speaker 2: wipe away the fact that heart and inflammation is transient

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Speaker 2: and it's fine, it's an acceptable risk factor.

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Speaker 3: People have died from myocarditis and it's not just you know,

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Speaker 3: fairy tale or anecdote from somebody or who's a friend

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Speaker 3: of a friend. It was in the New England Journal

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Speaker 3: of Medicine elcardiitis from vaccine induced that is a death

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Speaker 3: from myocarditis from vaccine induced myocarditis eighty five percent of

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Speaker 3: healthcare workers said no thank you to the COVID booster

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Speaker 3: last season.

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Speaker 4: When you go to the UK and look at.

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Speaker 3: Their recommendations, it's recommended for people over age seventy five,

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Speaker 3: not just sixty five seventy five or high risk, and

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Speaker 3: in France it's eighty years of age or high risk.

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Speaker 3: So we're really catching up to the rest of the

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Speaker 3: world with our new vaccine framework.

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Speaker 2: Well, I notice also that the new updated Maderna booster

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Speaker 2: is a fraction of the original dose, and on top

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Speaker 2: of that they have to have the warning about art inflammation.

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Speaker 2: So do you believe that they have lessen the dose

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Speaker 2: because of they were found to have more cases of

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Speaker 2: myocarditis and hard inflammation than Pfizer, which had a lower dose.

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Speaker 4: I don't know the rationale.

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Speaker 3: It is true that there were higher rates of myocarditis

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Speaker 3: reported in the past with the past Moderna versus Pfizer

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Speaker 3: COVID vaccines. The recent MODERNA vaccine approval was only for

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Speaker 3: high risk, it was a limited group and they agreed

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Speaker 3: to do a randomized control trial as a part of

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Speaker 3: that approval. And it is as you said, Nicole, it

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Speaker 3: is a so I don't want to say it's a

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Speaker 3: lightweight version, but it only includes some parts of the

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Speaker 3: protein of the spike protein, not the entire spike protein

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Speaker 3: or the majority of the spike protein as the current

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Speaker 3: MODERNA vaccine that's on the market. So it is very

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Speaker 3: similar but does not include the entire protein of the spike.

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Speaker 2: It'll be interesting to see what happens that. I mean,

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Speaker 2: the most recent ACIP meeting by the CDC in April,

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Speaker 2: I believe it was, they did not vote on updated

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Speaker 2: recommendations for the COVID booster and they said maybe it'll

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Speaker 2: happen in June, even though it kind of, you know,

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Speaker 2: I think it was the lightweight version of just saying

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Speaker 2: this should be a decision between patients and doctors on

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Speaker 2: the CDC immunization recommendation. When you're talking about the Affordable

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Speaker 2: Care Act and what is really going to be recommended

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Speaker 2: and covered by insurance is going to be based on

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Speaker 2: what the ACIP votes on.

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Speaker 1: And they could go either way.

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Speaker 2: They could continue the path that they've been going down

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Speaker 2: for the last four to five years of universal recommendations,

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Speaker 2: or they're going to.

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Speaker 1: Do it risk base.

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Speaker 2: And I have a feeling with your leadership and if

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Speaker 2: the FDA obviously you do have some influence there at

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Speaker 2: the CDC looking at the data. It'll be interesting to

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Speaker 2: see what they do and hopefully they'll give some more

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Speaker 2: clarity on that. You know, and I know that big

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Speaker 2: pharma does tend to.

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Speaker 1: Get a bad rap.

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Speaker 2: We talk about profit mongering and everything, but we rely

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Speaker 2: heavily on them in innovation, especially in healthcare. I mean,

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Speaker 2: they are the reason that we're living longer. And so

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Speaker 2: how do you at the FDA plan to foster a

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Speaker 2: relationship with innovation in the pharmaceutical industry but also holding

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Speaker 2: firm on safety and efficacy standards.

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Speaker 3: At the FDA, we would like to see more cures

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Speaker 3: and meaningful treatments for Americans.

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Speaker 4: That is one of our top priorities.

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Speaker 3: We also want to see a discussion of the root

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Speaker 3: causes of the rising rates of cancer and young people,

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Speaker 3: of the chronic disease apidemic in children.

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Speaker 4: We can't keep.

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Speaker 3: Medicating our population at scale. We have to look at

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Speaker 3: food as medicine and the microbiome, and look at snap programs,

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Speaker 3: and look at the food supply and the chemicals that

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Speaker 3: are banned in other countries but allowed in the United States.

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Speaker 3: We have to look at chemicals, exposures that don't exist

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Speaker 3: in other countries. Ultra processed food was a theme in

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Speaker 3: the report. Percent of the kids of the food kids

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Speaker 3: consumer is ultra processed. And how about we talk about

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Speaker 3: light exposure in children and circadie and rhythms. We've never

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Speaker 3: really been talking about this. It's time to broaden that conversation.

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Speaker 3: So we want to see more cures and meaningful treatments.

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Speaker 3: We're doing a lot to cut the red tape, to

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Speaker 3: streamline the process and create new pathways for new treatments.

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Speaker 3: At the same time, we're spending a lot of time

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Speaker 3: on food, which is why you saw our action to

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Speaker 3: remove all petroleum based food dies from the market.

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Speaker 1: So I mean you anticipated my next question.

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Speaker 2: Because the FDA does historically focus more on drugs than

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Speaker 2: on prevention nutrition. With Secretary Kennedy as HHS secretary, obviously,

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Speaker 2: I imagine the food industry is taking more of a priority.

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Speaker 1: We're already starting to see that. You know, what can

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Speaker 1: we expect?

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Speaker 2: You know, from an FDA standpoint, you already mentioned petroleum

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Speaker 2: based food dies, but you also have like a spartane

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Speaker 2: and you know some of the seat oil and ultra

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Speaker 2: processed foods these are all linked to chronic illness, yet

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Speaker 2: still considered safe by the FDA.

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Speaker 3: We work closely with NIH, and NIH is going to

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Speaker 3: be commissioning some really important studies looking at these root

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Speaker 3: causes and chemicals. We have to talk about the environmental

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Speaker 3: exposures and chemicals that cause cancer, not just the chemo

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Speaker 3: to treat it. And by and large, our entire medical

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Speaker 3: industrial research complex has been focused really on just the treatments.

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Speaker 3: And we're not winning playing whaca mole like this. We're

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Speaker 3: not winning or country gets sicker. We have the most obese,

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Speaker 3: the most insulin resistant, the most disabled, the most.

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Speaker 4: Medicalized population in the history of the world. We've got

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Speaker 4: to stop.

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Speaker 3: Well, you don't have the time or resources or energy

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Speaker 3: to just stop and put your head up and look

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Speaker 3: around and say, what's going on? Look at our population.

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Speaker 3: It has gotten sicker over the last fifty years. In

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Speaker 3: terms of cutting edge operations and chemo drugs and gene therapy,

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Speaker 3: modern medicine has been a fifty year success, but in

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Speaker 3: terms of the health of the population, it's been a

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Speaker 3: fifty year failure. And so we now want to talk

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Speaker 3: about food and that is a huge priority for this

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Speaker 3: FDA and this administration.

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Speaker 1: You're listening to wellness and mass We'll be right back

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Speaker 1: with more.

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Speaker 2: It always sounds good to say, well, we want to

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Speaker 2: make sure that we have the good research on it.

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Speaker 1: We have the data.

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Speaker 2: If we're talking about some specific foods, you know, no

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Speaker 2: one wants the government to come in and take away

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Speaker 2: something that they like.

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Speaker 1: But the problem with that.

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Speaker 2: Is that's going to be a lot of big population

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Speaker 2: based studies. You're going to have a lot of correlative

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Speaker 2: data confounding, and it might be really difficult to pinpoint.

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Speaker 2: I mean, a lot of the stuff we're talking about

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Speaker 2: already has animal and rodent studies that show cancer causing potential.

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Speaker 2: So how are you going to do that on larger

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Speaker 2: scale with humans.

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Speaker 3: Well, you're right, we cannot expect to do ten year

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Speaker 3: randomized control trials. I mean, you know, people who wanted

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Speaker 3: us to hold off on our action on food dies,

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Speaker 3: we're saying, oh, we need more research, we need more resar.

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Speaker 3: When you have enough suspicion that we may be harming children,

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Speaker 3: why take the risk. And that's why we decided to

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Speaker 3: move ahead with the action on food dies. We're doing

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Speaker 3: it with other chemicals. You may have seen that the

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Speaker 3: company that makes Skittles just announced they're going to remove

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Speaker 3: titanium dioxide.

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Speaker 1: Can you believe there was titanium dioxide and Skittles to

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Speaker 1: begin with?

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Speaker 4: Well, that's the question A lot of people are asking.

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Speaker 3: You know, it's not allowed in other countries, and so

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Speaker 3: I don't think our childhood obesity diabetes epidemic is a

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Speaker 3: will power problem. I don't think we should be blaming

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Speaker 3: the kids. This is something we are doing to kids,

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Speaker 3: and we have to look at everything.

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Speaker 1: Well, the FDA has been speaking of olesity.

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Speaker 2: The FDA has been fast tracking drug approval approvals kind

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Speaker 2: of at an unprecedented rate, it feels like, but post

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Speaker 2: market safety concerns tend to follow. I mean we see

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Speaker 2: things that get approved and then it gets taken back.

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Speaker 2: I have major concerns about the GLP one drugs like

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Speaker 2: ozempic and wigobi. I have gone on air publicly saying

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Speaker 2: I think there are incredible benefits to this. I think

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Speaker 2: they decrease systemic inflammation. Maybe you're getting more insulin sensitivity.

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Speaker 2: You're seeing lower cholesterol rates, lower rates of cardiovascular disease,

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Speaker 2: and everything that comes along with focusing on the metabolic

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Speaker 2: issues that people are having.

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Speaker 1: But do you believe the FDA has been maybe.

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Speaker 2: Too quick to kind of green light the broader indications

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Speaker 2: and use of these medications because we don't really have

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Speaker 2: long term safety debt.

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Speaker 4: Yeah.

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Speaker 3: Our job is to review applications that present clinical data

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Speaker 3: and to decide whether or not that data warrants us

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Speaker 3: to green light a drug for use by doctors. Now,

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Speaker 3: the key is doctors have to use their judgment and

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Speaker 3: wisdom on a prescription basis to properly select. So it

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Speaker 3: is a complex problem and so you know, what we

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Speaker 3: are trying to do is to empower people with information,

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Speaker 3: allow doctors to have access to treatments, and to cut

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Speaker 3: the red tape at the FDA while focusing on the

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Speaker 3: root causes. That's sort of our charge as a regulatory body. Now,

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Speaker 3: the work of all the health agencies and government have

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Speaker 3: a very comprehensive approach to health.

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Speaker 4: We have been at the center for.

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Speaker 3: Medicare and Medicaid throwing good money after bad into a

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Speaker 3: broken system. We have to not just talk about how

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Speaker 3: to fund our broken healthcare system, but how to fix

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Speaker 3: our broken healthcare system. And so Memonaz is a transformational

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Speaker 3: leader there. One of the smartest guys i've ever met.

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Speaker 3: Ja Bodicharia has taken a fresh new look on funding

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Speaker 3: studies on root causes.

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Speaker 4: There's a root cause that's right in front of our eyes.

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Speaker 3: And that has been relegated to sort of the fringe

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Speaker 3: of NIH research.

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Speaker 4: And so now that legitimate science is going.

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Speaker 3: To get the proper we're funding to be able to

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Speaker 3: do the proper studies. So we're taking a comprehensive approach,

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Speaker 3: and you know, we're doing our best. This is a

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Speaker 3: healthcare system that has been on the wrong track for

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Speaker 3: over fifty years, so we're going to do everything we can.

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Speaker 3: And at the FDA, I think one thing we can

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Speaker 3: do is partner with developers instead of just being a

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Speaker 3: receive only mode.

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Speaker 2: I continue to have concerns about these GLP ones. I'm

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Speaker 2: starting to see the cases of blindness. I think potentially

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Speaker 2: we might start seeing those medullary cancer diagnoses. And the

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Speaker 2: fact that there's expanded use now in kids. It seems

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Speaker 2: like it's very much going in the wrong direction when

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Speaker 2: we are trying to get towards the Make America Healthy

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Speaker 2: Again agenda and going to those root causes you keep

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Speaker 2: talking about, But it seems our society and even our

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Speaker 2: medical institutions, and our medical people who are making recommendations

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Speaker 2: are saying for kids and adolescents and just about everyone

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Speaker 2: to start taking these medications. And it's not you at

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Speaker 2: the FDA, but it certainly has me concerned. And I

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Speaker 2: hope we don't look back in ten years like we

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Speaker 2: are doing at opioids and say we should have known that.

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Speaker 4: And that's the benefit of being able to use big data.

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Speaker 3: Now, we're setting up a system so that we'll have

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Speaker 3: eyes on drugs and devices as soon as they're approved,

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Speaker 3: so we don't learn nearly twenty years later that a

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Speaker 3: drug like OxyContin may have been involved in the deaths

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Speaker 3: of many, many, many thousands of Americans, or that byox

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Speaker 3: may have killed up to thirty eight thousand Americans. That

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Speaker 3: was kind of realized five years after it was approved.

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Speaker 4: Why aren't we.

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Speaker 3: Getting eyes on these data in real time as soon

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Speaker 3: as they're approved. So now with the power of big data,

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Speaker 3: that's one of our big charges. We're also trying to.

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Speaker 4: Use AI to do our job better.

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Speaker 3: This week we announced AI being used for scientific reviews

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Speaker 3: agency wide, and we had a goal of January of

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Speaker 3: June thirtieth. We are ahead of schedule. And under budget.

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Speaker 3: And now, as of today, all the reviewers that do

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Speaker 3: scientific reviews and inspectors and core staff at the FDA

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Speaker 3: have access to this AI review and one of them

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Speaker 3: told me the AI did in six minutes what would

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Speaker 3: normally take them two to three days to do. So

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Speaker 3: we're trying to modernize our agency so we can provide

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Speaker 3: real time information to guide people.

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Speaker 2: Ahead of schedule and under budget. I think those would

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Speaker 2: be very proud of you guys there. I just want

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Speaker 2: to ask you about one more thing and then I'll

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Speaker 2: let you go. I know we're going over time.

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Speaker 1: Now. I want to talk about small.

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Speaker 2: Business owners, specifically American small business owners who are in

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Speaker 2: like the wellness and beauty industry, because they're pretty furious

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Speaker 2: with the FDA because the FDA is regulating products like

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Speaker 2: shampoo and conditioner, lotions and makeups kind of like this

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Speaker 2: with the same intensity as pharmaceutical drugs. Now, if you

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Speaker 2: you know, if you go back to like President Trump's

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Speaker 2: America First policy, it's all about protecting American workers and businesses,

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Speaker 2: Yet the FDA is kind of doing the opposite when

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Speaker 2: it comes to the hygiene and wellness industry here in

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Speaker 2: the United States. Specifically the small business owners, because they

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Speaker 2: are heavily regulated by the FDA.

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Speaker 1: They are subjected to constant routine inspections.

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Speaker 2: They're quite stressful, quite expensive, all the testing and everything

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Speaker 2: they have to do. But if anything is made in

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Speaker 2: China or some other country, it can just be sent

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Speaker 2: to the United States and then we buy it on

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Speaker 2: Amazon or wherever, and it is not subject to the

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Speaker 2: same scrutiny as the American small businesses that are producing

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Speaker 2: pretty much the same thing are.

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Speaker 3: Yeah, we're looking at that nicole because there are a

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Speaker 3: lot of frustrations out there. And our goal at the

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Speaker 3: FDA is similar to the goal that Secretary Kennedy has

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Speaker 3: put forth, and that is we want to implement gold

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Speaker 3: standard science and common sense. And common sense is a

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Speaker 3: big theme and a lot of what we're doing. Sometimes

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Speaker 3: I look at processes at the FDA and I think,

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Speaker 3: this doesn't makes sense.

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Speaker 4: Why do we do it this way?

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Speaker 3: And some of it is from legacy traditions, some of

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Speaker 3: it is because of the sort of natural history of

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Speaker 3: the growth of a bureaucracy over time, and so we

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Speaker 3: have to re examine all of that.

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Speaker 4: And one other frustration.

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Speaker 3: I've heard people say is that they don't know what

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Speaker 3: the FDA is thinking. And so for investors, for small

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Speaker 3: businesses to come up with a new product, or to

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Speaker 3: invest in a business or product, you want predictability. You

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Speaker 3: just want to know what the rules are. You want

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Speaker 3: to level playing field. So we're doing a lot to

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Speaker 3: be out there. It's one of the reasons why I'm

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Speaker 3: talking to you now. It's one of the reasons why

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Speaker 3: we have been on video almost every day in some format,

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00:23:45,840 --> 00:23:49,480
Speaker 3: being out there letting people know exactly what we are thinking.

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00:23:49,960 --> 00:23:52,080
Speaker 3: Just like we put out in the New England Journal

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Speaker 3: of Medicine our framework for a new COVID vaccine regulation.

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Speaker 4: And so we're going to keep doing that. We're going

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Speaker 4: to keep talking.

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Speaker 3: We're going to try to buy predictability to businesses and investors.

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Speaker 2: Well, the trust gap between the American public and the

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Speaker 2: FBA has never FDA has never been wider. Being on

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Speaker 2: camera and being transparent forthcoming is certainly the step in

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Speaker 2: the right direction.

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Speaker 1: Final thoughts, what do you say to the people who

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Speaker 1: feels the agency protects industry more than the people.

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Speaker 3: Yeah, so we have to both partner with developers and

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Speaker 3: work with them and at the same time ensure that

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Speaker 3: the scientific Review is impeccably independent, and so that's one

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Speaker 3: of the reasons why I announced that we're going to

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Speaker 3: do a lot in partnership with the industry. We're we're

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Speaker 3: starting this week a national listening tour with pharmaceutical executives.

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Speaker 3: But one of my first actions was to remove pharma

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Speaker 3: and industry members from all FDA advisory committees where statutorily possible.

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Speaker 3: And so that was basically addressing this concern that the

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Speaker 3: public has that the industry he has had points, the

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00:25:01,960 --> 00:25:05,280
Speaker 3: agency has had points in its history where it may

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Speaker 3: have had pockets of capture by the industry that it's

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Speaker 3: supposed to regulate.

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Speaker 4: So we're going to do our best.

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Speaker 3: I don't think anyone has any question what our motives are.

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Speaker 4: Our motives are to serve the American people.

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Speaker 2: And you've also said that you will not be jumping

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Speaker 2: right to a pharmaceutical company as one of their lead

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Speaker 2: advisors as soon as you step away from the FDA.

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Speaker 4: You know me, and you know that's not me.

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Speaker 2: Know, Martin McCarey, thank you so much for joining us today.

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Speaker 2: I really appreciate you taking the time.

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Speaker 1: I know Hope as you are.

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Speaker 4: Great to see Nicole.

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Speaker 2: I want to thank doctor Martin McCarey for joining us

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Speaker 2: and offering a candid look at where the FDA is headed.

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Speaker 2: Whether it's increasing public trust, streamlining approvals, or embracing new innovations,

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Speaker 2: it's clear we're entering a pivotal time and health policy.

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Speaker 2: As always, thank you for listening to Wellness and Mass.

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Speaker 2: I'm doctor Nicole Sapphire on America's number one podcast network, iHeart.

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00:25:58,119 --> 00:26:00,879
Speaker 2: Follow Wellness un Mass with doctor Nichol's Sapphire and start

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00:26:00,920 --> 00:26:03,760
Speaker 2: listening on the free iHeartRadio app for wherever you get

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00:26:03,800 --> 00:26:05,600
Speaker 2: your podcasts, and we'll catch you next time