July 10, 2025 • 22 mins
In this episode, Lisa interviews FDA Commissioner Marty Makary about his transition from medicine to government, emphasizing the need for transparency and accountability at the FDA. They discuss workforce reductions, stricter standards for COVID-19 vaccine approvals, expanded warnings about myocarditis, and efforts to eliminate synthetic dyes from food. Makary also highlights plans to modernize dietary guidelines and reduce animal testing. The Truth with Lisa Boothe is part of the Clay Travis & Buck Sexton Podcast - new episodes debut every Tuesday & Thursday.
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Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Speaker 1 (00:00):
Welcome to the Truth with Li Sabooth, where we get
to the heart of what matters to you. Today, we're
going to talk about public health with my friend and
former Fox News colleague, FDA Commissioner Marty McCarey. I'm going
to ask him about his confirmation journey. Don't you just
want to know what.
Speaker 2 (00:17):
Is that like? So I'll ask him. We'll also talk about.
Speaker 1 (00:20):
Some of the bold moves that the FDA is making
and how it's being received by the media. Are they
telling the truth? I mean, we know they're not, but
we'll ask him about that. We'll also unpack some of
the changes that the FDA is making with the COVID
nineteen vaccine, particularly more advanced warnings about my carditis with
young men as well, and we'll talk about some of
(00:40):
the other changes that are happening at the FDA, like
fast tracking the drug review program or cutting back on
some of the animal testing. Why is that done? Does
it even need to be done? But I know another
topic that you guys are really interested in is the
Make America Healthy Again movement, So we'll talk about the
changes that he's making at the FAD about that.
Speaker 2 (01:01):
Also pushing back.
Speaker 1 (01:02):
On some of these synthetic dies. I know that they're
kind of in a fight right now with Mars, the
maker of Eminem's over synthetic die, so we'll dig into
that as well. So a lot to talk about with
my friend and also just a smart guy with common
sense or FDA Commissioner Marty McCarey, stay tuned. FDA Commissioner
(01:25):
Marty McCarey now, and I have to call you a
commissioner because you're you're a big You're a big deal.
You're a big deal now, so.
Speaker 2 (01:32):
Great to talk to you least, so I call me
Marty please.
Speaker 1 (01:35):
Well, I'm first of all, I'm so proud of you.
I was so excited when you got picked because well,
first of all, you're just brilliant, but secondly, you just
you use common sense, which doesn't happen anymore. We kind
of want our public health officials to obviously use their backgrounds,
as you know, you have a you know, exceptional background,
(01:57):
but but also to use common sense. So I would
so happy for you and just excited for the country.
Speaker 2 (02:03):
Thanks so much, Lisa. There is a common sense deficiency
syndrome that we're actively trying to treat nationwide in our
healthcare system, and.
Speaker 1 (02:12):
I'm sure you're still dealing with it in terms of
like the media coverage and trying to explain things to
people and like, you know, like dealing with But I
did want to ask you, is I've just always been
curious what was going through the confirmation process.
Speaker 2 (02:27):
Like the biggest thing in my mind was, you know,
I've been doing trauma surgery in the past, and cancer
surgery and complex medical stuff, so the stress didn't bother
me at all. It was actually less stressful than a
complicated operation I was doing at Johns Hopkins in my
career prior. But I was sort of mourning leaving clinical
(02:48):
practice because I did my last operation the day before
at the hospital and I just realized, I'm walking into
this sort of crazy world of politics. I'm gonna miss
being a doctor. And when I was a sergeant at Hopkins,
everybody wanted you to succeed. I mean people in the
community you never met, family members, the patients, your staff,
(03:11):
and in these jobs in government. The second you walk in,
a third of the country wants you to fail. And
for me, that was that's a very funny feeling. Yeah,
because I was.
Speaker 1 (03:21):
Even reading you know, like stat news has a piece
recently about how, you know, it's sort of like reduced
workforce that President Trump is wanted across the board at
all these different agencies. How they're saying it's like compromising
the agency's work. And then obviously the people who laid
off are upset. Have you have you been surprised by
some of that coverage or I guess, you know, any
(03:44):
anything you want to kind of like weigh in on
that with.
Speaker 2 (03:47):
Overall, I've actually been pleased with the coverage. It's been
good on the whole. But there are a couple of
outlets that are always going to write these pieces with
anonymous sources and it's just gossip. One thing that some
of these sort of doomsday writers always leave out when
they talk about the reduction in force. You know, the
(04:09):
FDA reduced its workforce by about fifteen percent. The goal
was to get back to twenty nineteen levels, and that
happened just before I got into office. Part of the
doge cotts in early retirement did reduce the workforce. But
one thing that the reporters always leave out when they
knock on it is that the FDA has doubled in
(04:32):
size since two thousand and seven. There were nine thousand
employees at the FDA here in two thousand and seven
and then went up to nearly twenty thousand last year.
And so nobody talks about the fact that it's ballooned
up and that we had twelve travel offices and dozens
of people who were chief strategy officers and two thousand
(04:54):
HR people and budget procurement people. And so when Southwest
Airlines announced, I think it was the same week as
the cuts that the FDA, that they reduced their workforce
by fifteen percent, no one said, well, this is going
to result in airline safety problems at Southwest. They thought, well,
this is a resizing of the organization. Well, the government
(05:17):
sometimes needs to be re evaluated. And one thing I
learned about the FDA is that when we walked in here,
we discovered a lot of stuff. One thing is that
it was a faifdom culture. There were sort of empires
that were being built with duplication of services, of websites,
of it, of communications staff, of lobbyists to the Capitol Health.
(05:40):
We learned that cells on Americans being treated for cancer
were being gene edited in China. The cells were being
sent to China and then gene edited by the Chinese
and sent back to the United States. We shut that down.
There's just a lot of we discovered a lot of
insane things that we discovered, and so we've been sort
(06:03):
of in a discovery mode, meeting with people on the
ground at the FDA, asking them what's on your mind,
what needs to change, what do you need to do
your job better. So we've been very operational. I've been
very much on the ground and not floating around in
the media and going to sort of all the cocktail
receptions and conference panels that you get invited to in
(06:24):
these jobs. I've been very much on the ground here
trying to make the FDA more streamlined, better cut the
red tape, and talk about food not just drugs.
Speaker 1 (06:33):
We're also not going to get invited with that mentality,
so you might not have to worry about it because
they're not going to invite you.
Speaker 2 (06:43):
You know.
Speaker 1 (06:43):
Part of that with you know, obviously one concern a
lot of or you know what, Americans have a lot
of concerns with public health, particularly since COVID, but just
the power of the pharmaceutical industry and I know at
the time that this will be made public the FDA
will announce that decisions on drug approval will be made public.
Walk us through that, the significance of that, and then
(07:04):
also how that will sort of reduce the power of
lobbyists and just you know that transparency that's so important
for Americans.
Speaker 2 (07:14):
Well, first of all, this agency belongs to the American people.
Some people perceive that it's captured, and I'm happy to
report that we have done everything possible to ensure that
the review at the FDA is scientifically independent. One of
my first actions was to remove pharma members from FDA
(07:36):
advisory committees wherever statutorily possible, and to ensure that we
are entirely independent. At the same time, we have to
partner with the pharma industry because we want to see
more cures come to market. We want to see cures
for these rare diseases and intractable neurodegenerative diseases, for diabetes,
for blindness, for stage four cancer, and I believe there's
(07:59):
some really promising stuff in the pipeline. You know, the
cool thing about this job at the FDA is you
get to see what's sort of on the horizon, what's possible,
and it's pretty exciting. We just have to cut the
red tape. So when it comes to pharma, you know,
I have personally taken a pledge that I will not
work for big pharma after my time as commissioner. Shareholders
(08:25):
don't have to just listen to the spin of the
companies that get these FDA decision letters. But one thing
we learned is that when companies get a decision a
rejection from the FDA, they will spin the the decision
to their shareholders. Well, now these will be public and
it'll also help inventors and other drug developers to understand
(08:50):
what the FDA wants. More transparency is good. In my opinion,
no society has ever ushered in transparency and then later said,
you know, that was a bad idea. Let's go back
to keeping people in the dark, you.
Speaker 1 (09:02):
Know, and to that vain you know. I know the
trumpetminstration has made changes across the board with the you know,
different agencies regarding the COVID nineteen vaccines. I know what
the FDA specifically, you guys have mandated expanded warnings that
maya coroditis. You know, the risks from the mRNA based
COVID vaccines. Also, you know, changes in terms of shifting
(09:26):
policy to limit the annual COVID vaccine approvals to adults
sixty five and older.
Speaker 2 (09:31):
Kind of walk us through.
Speaker 1 (09:32):
Some of the changes that you guys have made in
regards to the COVID nineteen vaccine and why did you
make them.
Speaker 2 (09:38):
Yeah, so we basically said, we're going to use the
same scientific the same scientific standard we use for other
drugs for the COVID booster shot in healthy Americans. We're
not going to just rubber stamp blindly COVID boosters every
year without clinical data that's updated, and so that is
a position that's generated a lot of controversy in the
(10:01):
medical field. We made our framework very clear in the
New England Journal of Medicine. We published it because I
believe the public deserves total transparency on exactly what we're thinking,
and we said, look, if you want to create a
COVID booster shot for young healthy Americans, do a clinical trial.
(10:22):
We will review that clinical trial and we will make
a decision. We're not just going to put a blindfold
on and rubber stamp approve every single COVID shot booster
for young healthy kids that comes across the desk. So
we're very clear we're not playing games. At the same time,
we do think Terry Kennedy's promised that if you want
(10:46):
a vaccine, you can get a vaccine. We're not taking
away people's vaccines. We are our philosophy is still very
much aligned with the message that he's put out there
on that.
Speaker 1 (10:57):
Well, we've also just learned more about some of the
risks with the COVID vaccine. You know, particularly when you know,
with younger people with myocarditis, young men when they don't
really need you know, they're not at risk from COVID,
and so you know, the risks from the vaccine could
outweigh the risks from getting COVID.
Speaker 2 (11:17):
So, you know, I guess what.
Speaker 1 (11:18):
Have we learned about some of the risks from the
COVID vaccine.
Speaker 2 (11:22):
Well, once, you know, once we got here, we learned
a lot of stuff, as I mentioned, and one of
the things we learned is that there were concerning safety
signals about milecarditis in young men after the COVID shot
that were slow walked. They were not acted upon in
an expeditious way when they were discovered here at the FDA,
(11:44):
And so we did a thorough review with the best
available information that we had and we issued a warning
about milecarditis with the COVID shot that was long overdue.
And so there are many things like that where now
we're going through what's the in the inventory here, what
(12:05):
are the safety concerns of our scientists that were suppressed,
and how can we act accordingly.
Speaker 1 (12:12):
Quick commercial break more With FDA Commissioner Marty McCarey, you
guys have or you know, collectively obviously with Secretary Kennedy
at HHS, you know, overseeing all this more broadly, but
pushed I think you called it love with you know,
sort of pushing some of these companies, you know, food
(12:34):
and beverage companies to get rid of some of these
synthetic guyes that Americans are concerned about, particularly with the
Make America Healthy Again movement with success I believe, like Jello,
what is it, Lucky Charms? You know, there's been some
companies that have said that they're going to aim to
do this by twenty twenty seven. So there's been movement,
(12:56):
positive movement. However, you know marsarticularly with Eminem's, they're saying
we're not going to get on board. They're fighting you
guys with it. Why are synthetic dies dangerous. And I
guess what are sort of the next steps that the
administration that you guys are planning on taking in regards
to that.
Speaker 2 (13:17):
Well, first of all, this has been a big issue
whereby Republican, Democrat and independent moms showed up in high
numbers to vote for President Trump over this actual issue
is very issue that President Trump and Secretary Kennedy have championed.
There are you know, we can learn from listening to
parents when parents tell you that their child had bad behavior,
(13:44):
or had attention deficit disorder, or had behavioral problems at school,
and then they eliminated all of these artificial petroleum based
food dies from the diet of their child, and then
the child suddenly improved to having normal behavior. That's not
a randomized control trial, but we as scientists can learn
(14:04):
that is a that is a data point, and in conglomeration,
these are data points we can learn from. There are also,
by the way, randomized control trials, for example, one in
the Lancet the Medical Journal Lancet showing that petroleum based
food dies were associated with attention deficit disorder. So what
are we what are we waiting for? Why do we
(14:25):
take risks. When we have an epidemic of child behavioral
problems and attention deficit disorder, why do we just blindly
go down this path of drugging our nation's children at
scale and not talking about the root causes. And personally,
I don't think kids need glow in the dark fruit loops.
I mean these are there are natural alternatives that can
(14:48):
provide color. And we went on the offense and approved
several natural food dies to replace these petroleum based artificial dies.
We're going to announce another one next week. But we
have been getting these natural dyes out on the market expeditiously,
and we took a bold step to ask companies to
(15:09):
stop using the nine petroleum based food dies in the
US food supply. I don't think the chronic disease illness
problem in American children is a will power problem. Something
is going on in the food supply. Now. On Mars,
you mentioned Mars, I think the reporting out there there
has not been accurate that I've been seeing about Mars. Mars.
(15:33):
Mars is a family owned business. They want to make
improvements in the health quality of their foods. We've had
very productive conversations with them, and we're going to be
meeting again with them. I'm meeting with them, i think
in the next week or two, and I'm optimistic that
they are going to join this bandwagon. Effective food manufacturers,
(15:55):
Craft Hinds, General Mills, dan O, and Yogurt, Jello, all
these products that have pledged to support Secretary Kennedy's vision
for a food supply for American children without these petroleum
based eyes.
Speaker 1 (16:10):
What would you say are the most important things the
Trump administration has done so far to make America healthy again.
Speaker 2 (16:18):
Well, we are rewriting the food guidelines, the dietary guidelines
that has been probably one of the greatest sources of
health misinformation in the United States in our history. You know,
the broken food pyramid written by the industry. We are
rewriting that right now at the FDA, and we should
(16:39):
have that out later this year. We have taken an
inventory of all the chemicals in our food supply. We're
doing things to educate the public about chemicals. It's not
just the petroleum based dies. One company took action, the
maker of Skittles to remove titanium dioxide. Another concerning chemical.
(17:01):
We are promoting whole foods and grains without the fiber
stripped off of the grain as we typically see with
ultra processed foods. You know, seventy percent of the diet
of kids now is ultra processed foods. So we're bringing
a lot of attention to that issue. And you're seeing
for the first time ever in this Trump administration, the
(17:23):
SNAP program changing, whereby states are being granted waivers to
no longer use taxpayer dollars to fund ultra processed junk
food and sugary drinks. We've got to start talking about
school lunch programs, not just putting every kid on ozembic.
(17:44):
We've got to talk about environmental exposures that cause cancer,
not just the chemo to treat it. And so the
NIH has a very aggressive agenda to now study the
root causes of chronic diseases, because up till now, most
of the focus has been just on this whack a
mole game of medicating and operating on people after they
(18:05):
are very sick.
Speaker 1 (18:06):
I know, I know that you have pledged to reduce
and you know, cut some of the animal testing requirements
and animal testing that's being done. What can you tell
us about some of these tests on animals and why
is that important?
Speaker 2 (18:22):
Well, a lot of the animal testing that's routinely done
for drugs that are being evaluated here at the FDA
are unnecessary and just to take a step back, Lisa,
I don't believe that God put animals on planet Earth
for us to abuse or torture, and so.
Speaker 1 (18:40):
We can crouch you would disagree with you.
Speaker 2 (18:44):
Continues. We can modernize the agency and use computational modeling.
Now AI technology that looks at a molecule and can
predict its toxicity in humans better than it animal test
predicting toxicity in many instances, and there's something called organ
(19:05):
on a chip technology where the drug is tested on
a cell culture medium or what we call an organoid,
a mini organ in a lab. We don't need to
be torturing animals and keeping them in captivity in many instances.
So we have an aggressive roadmap to reduce animal testing
that we introduced in one of my first weeks in office.
I've been in office, gosh, I guess one hundred days now,
(19:29):
this is the one hundred day mark, and so we've
had this aggressive plan to reduce animal testing, remove the
petroleum based eyes. We've got AI. Now for the scientific reviewers,
it's speeding up their process, and we have a pilot
program to reduce the decision time of the FDA from
nearly a year to just one or two months. All
(19:50):
of these things are aimed at modernizing the agency and
cutting the red tape so we can streamline the regulatory
process and deliver more cures and meaningful treatments to the
American people.
Speaker 1 (20:04):
Yeah, there's been one of the before we go, one
of the big lines of attack against the Trump administration
is you know, they're saying, you guys are cutting research
and it's going to put lives in danger.
Speaker 2 (20:16):
You know, et cetera, et cetera.
Speaker 1 (20:19):
Has our ability as a country to you know, do
various important health research regarding cancer or what have you.
Has that been impacted by you know, cutting some of
these grants.
Speaker 2 (20:31):
Well, if we're talking about the NIH, when Jay bid
Trina walked into the NIH and I talked to him
a lot, we're friends, and he walked into a mess.
Fourteen percent of ANIH grants were going to health equity
and diversity research. That was descriptive. It did nothing for
these disparities that we see in the United States. We
(20:53):
were funding a lab and a group that likely brewed
up the cronnavirus that killed twenty million people and cost
twenty five trillion dollars worldwide, and they had done very
little research on the root causes of chronic diseases as
(21:14):
the health of the population has gotten worse. I mean,
if you measure healthcare by sophisticated gene editing or operations
that we do in surgery, yeah, there are incredible success stories.
But if you measure the performance of the US healthcare
system over the last fifty years by the health of
the population, it's been a fifty year failure. And so
(21:36):
Jay Buddetarni is doing an incredible job, especially with all
the fake news out there about NIH dollars being cut.
Not one NIH dollar has been cut. There's not a
single dollar to the NIH budget that has been cut.
Medicaid has not been cut. There are reasonable limits to
(21:57):
the growth rate of Medicaid. And so there's a lot
of incorrect information out there on what's happening. But of
course it's from the usual, you know, fear minded reporting
on what's going on.
Speaker 1 (22:13):
Well, you've lived through that with COVID. So you're up
to speak with Commissioner Marty McCarey. Your friend just so
happy for you. Proud of you, and so glad you're
over at the FDA and we've got people like you
and government well.
Speaker 2 (22:28):
Thanks so much, Lisa, great to talk to you again,
great to connect. Thanks for having me.
Speaker 1 (22:34):
That was the FDA Commissioner, Marty McCarey and my friend.
Appreciate him for making the time to come on the show.
Appreciate you guys at home for listening every Tuesday and Thursday,
but of course you can listen throughout the week until
next time.
Welcome to the Truth with Li Sabooth, where we get
to the heart of what matters to you. Today, we're
going to talk about public health with my friend and
former Fox News colleague, FDA Commissioner Marty McCarey. I'm going
to ask him about his confirmation journey. Don't you just
want to know what.
Speaker 2 (00:17):
Is that like? So I'll ask him. We'll also talk about.
Speaker 1 (00:20):
Some of the bold moves that the FDA is making
and how it's being received by the media. Are they
telling the truth? I mean, we know they're not, but
we'll ask him about that. We'll also unpack some of
the changes that the FDA is making with the COVID
nineteen vaccine, particularly more advanced warnings about my carditis with
young men as well, and we'll talk about some of
(00:40):
the other changes that are happening at the FDA, like
fast tracking the drug review program or cutting back on
some of the animal testing. Why is that done? Does
it even need to be done? But I know another
topic that you guys are really interested in is the
Make America Healthy Again movement, So we'll talk about the
changes that he's making at the FAD about that.
Speaker 2 (01:01):
Also pushing back.
Speaker 1 (01:02):
On some of these synthetic dies. I know that they're
kind of in a fight right now with Mars, the
maker of Eminem's over synthetic die, so we'll dig into
that as well. So a lot to talk about with
my friend and also just a smart guy with common
sense or FDA Commissioner Marty McCarey, stay tuned. FDA Commissioner
(01:25):
Marty McCarey now, and I have to call you a
commissioner because you're you're a big You're a big deal.
You're a big deal now, so.
Speaker 2 (01:32):
Great to talk to you least, so I call me
Marty please.
Speaker 1 (01:35):
Well, I'm first of all, I'm so proud of you.
I was so excited when you got picked because well,
first of all, you're just brilliant, but secondly, you just
you use common sense, which doesn't happen anymore. We kind
of want our public health officials to obviously use their backgrounds,
as you know, you have a you know, exceptional background,
(01:57):
but but also to use common sense. So I would
so happy for you and just excited for the country.
Speaker 2 (02:03):
Thanks so much, Lisa. There is a common sense deficiency
syndrome that we're actively trying to treat nationwide in our
healthcare system, and.
Speaker 1 (02:12):
I'm sure you're still dealing with it in terms of
like the media coverage and trying to explain things to
people and like, you know, like dealing with But I
did want to ask you, is I've just always been
curious what was going through the confirmation process.
Speaker 2 (02:27):
Like the biggest thing in my mind was, you know,
I've been doing trauma surgery in the past, and cancer
surgery and complex medical stuff, so the stress didn't bother
me at all. It was actually less stressful than a
complicated operation I was doing at Johns Hopkins in my
career prior. But I was sort of mourning leaving clinical
(02:48):
practice because I did my last operation the day before
at the hospital and I just realized, I'm walking into
this sort of crazy world of politics. I'm gonna miss
being a doctor. And when I was a sergeant at Hopkins,
everybody wanted you to succeed. I mean people in the
community you never met, family members, the patients, your staff,
(03:11):
and in these jobs in government. The second you walk in,
a third of the country wants you to fail. And
for me, that was that's a very funny feeling. Yeah,
because I was.
Speaker 1 (03:21):
Even reading you know, like stat news has a piece
recently about how, you know, it's sort of like reduced
workforce that President Trump is wanted across the board at
all these different agencies. How they're saying it's like compromising
the agency's work. And then obviously the people who laid
off are upset. Have you have you been surprised by
some of that coverage or I guess, you know, any
(03:44):
anything you want to kind of like weigh in on
that with.
Speaker 2 (03:47):
Overall, I've actually been pleased with the coverage. It's been
good on the whole. But there are a couple of
outlets that are always going to write these pieces with
anonymous sources and it's just gossip. One thing that some
of these sort of doomsday writers always leave out when
they talk about the reduction in force. You know, the
(04:09):
FDA reduced its workforce by about fifteen percent. The goal
was to get back to twenty nineteen levels, and that
happened just before I got into office. Part of the
doge cotts in early retirement did reduce the workforce. But
one thing that the reporters always leave out when they
knock on it is that the FDA has doubled in
(04:32):
size since two thousand and seven. There were nine thousand
employees at the FDA here in two thousand and seven
and then went up to nearly twenty thousand last year.
And so nobody talks about the fact that it's ballooned
up and that we had twelve travel offices and dozens
of people who were chief strategy officers and two thousand
(04:54):
HR people and budget procurement people. And so when Southwest
Airlines announced, I think it was the same week as
the cuts that the FDA, that they reduced their workforce
by fifteen percent, no one said, well, this is going
to result in airline safety problems at Southwest. They thought, well,
this is a resizing of the organization. Well, the government
(05:17):
sometimes needs to be re evaluated. And one thing I
learned about the FDA is that when we walked in here,
we discovered a lot of stuff. One thing is that
it was a faifdom culture. There were sort of empires
that were being built with duplication of services, of websites,
of it, of communications staff, of lobbyists to the Capitol Health.
(05:40):
We learned that cells on Americans being treated for cancer
were being gene edited in China. The cells were being
sent to China and then gene edited by the Chinese
and sent back to the United States. We shut that down.
There's just a lot of we discovered a lot of
insane things that we discovered, and so we've been sort
(06:03):
of in a discovery mode, meeting with people on the
ground at the FDA, asking them what's on your mind,
what needs to change, what do you need to do
your job better. So we've been very operational. I've been
very much on the ground and not floating around in
the media and going to sort of all the cocktail
receptions and conference panels that you get invited to in
(06:24):
these jobs. I've been very much on the ground here
trying to make the FDA more streamlined, better cut the
red tape, and talk about food not just drugs.
Speaker 1 (06:33):
We're also not going to get invited with that mentality,
so you might not have to worry about it because
they're not going to invite you.
Speaker 2 (06:43):
You know.
Speaker 1 (06:43):
Part of that with you know, obviously one concern a
lot of or you know what, Americans have a lot
of concerns with public health, particularly since COVID, but just
the power of the pharmaceutical industry and I know at
the time that this will be made public the FDA
will announce that decisions on drug approval will be made public.
Walk us through that, the significance of that, and then
(07:04):
also how that will sort of reduce the power of
lobbyists and just you know that transparency that's so important
for Americans.
Speaker 2 (07:14):
Well, first of all, this agency belongs to the American people.
Some people perceive that it's captured, and I'm happy to
report that we have done everything possible to ensure that
the review at the FDA is scientifically independent. One of
my first actions was to remove pharma members from FDA
(07:36):
advisory committees wherever statutorily possible, and to ensure that we
are entirely independent. At the same time, we have to
partner with the pharma industry because we want to see
more cures come to market. We want to see cures
for these rare diseases and intractable neurodegenerative diseases, for diabetes,
for blindness, for stage four cancer, and I believe there's
(07:59):
some really promising stuff in the pipeline. You know, the
cool thing about this job at the FDA is you
get to see what's sort of on the horizon, what's possible,
and it's pretty exciting. We just have to cut the
red tape. So when it comes to pharma, you know,
I have personally taken a pledge that I will not
work for big pharma after my time as commissioner. Shareholders
(08:25):
don't have to just listen to the spin of the
companies that get these FDA decision letters. But one thing
we learned is that when companies get a decision a
rejection from the FDA, they will spin the the decision
to their shareholders. Well, now these will be public and
it'll also help inventors and other drug developers to understand
(08:50):
what the FDA wants. More transparency is good. In my opinion,
no society has ever ushered in transparency and then later said,
you know, that was a bad idea. Let's go back
to keeping people in the dark, you.
Speaker 1 (09:02):
Know, and to that vain you know. I know the
trumpetminstration has made changes across the board with the you know,
different agencies regarding the COVID nineteen vaccines. I know what
the FDA specifically, you guys have mandated expanded warnings that
maya coroditis. You know, the risks from the mRNA based
COVID vaccines. Also, you know, changes in terms of shifting
(09:26):
policy to limit the annual COVID vaccine approvals to adults
sixty five and older.
Speaker 2 (09:31):
Kind of walk us through.
Speaker 1 (09:32):
Some of the changes that you guys have made in
regards to the COVID nineteen vaccine and why did you
make them.
Speaker 2 (09:38):
Yeah, so we basically said, we're going to use the
same scientific the same scientific standard we use for other
drugs for the COVID booster shot in healthy Americans. We're
not going to just rubber stamp blindly COVID boosters every
year without clinical data that's updated, and so that is
a position that's generated a lot of controversy in the
(10:01):
medical field. We made our framework very clear in the
New England Journal of Medicine. We published it because I
believe the public deserves total transparency on exactly what we're thinking,
and we said, look, if you want to create a
COVID booster shot for young healthy Americans, do a clinical trial.
(10:22):
We will review that clinical trial and we will make
a decision. We're not just going to put a blindfold
on and rubber stamp approve every single COVID shot booster
for young healthy kids that comes across the desk. So
we're very clear we're not playing games. At the same time,
we do think Terry Kennedy's promised that if you want
(10:46):
a vaccine, you can get a vaccine. We're not taking
away people's vaccines. We are our philosophy is still very
much aligned with the message that he's put out there
on that.
Speaker 1 (10:57):
Well, we've also just learned more about some of the
risks with the COVID vaccine. You know, particularly when you know,
with younger people with myocarditis, young men when they don't
really need you know, they're not at risk from COVID,
and so you know, the risks from the vaccine could
outweigh the risks from getting COVID.
Speaker 2 (11:17):
So, you know, I guess what.
Speaker 1 (11:18):
Have we learned about some of the risks from the
COVID vaccine.
Speaker 2 (11:22):
Well, once, you know, once we got here, we learned
a lot of stuff, as I mentioned, and one of
the things we learned is that there were concerning safety
signals about milecarditis in young men after the COVID shot
that were slow walked. They were not acted upon in
an expeditious way when they were discovered here at the FDA,
(11:44):
And so we did a thorough review with the best
available information that we had and we issued a warning
about milecarditis with the COVID shot that was long overdue.
And so there are many things like that where now
we're going through what's the in the inventory here, what
(12:05):
are the safety concerns of our scientists that were suppressed,
and how can we act accordingly.
Speaker 1 (12:12):
Quick commercial break more With FDA Commissioner Marty McCarey, you
guys have or you know, collectively obviously with Secretary Kennedy
at HHS, you know, overseeing all this more broadly, but
pushed I think you called it love with you know,
sort of pushing some of these companies, you know, food
(12:34):
and beverage companies to get rid of some of these
synthetic guyes that Americans are concerned about, particularly with the
Make America Healthy Again movement with success I believe, like Jello,
what is it, Lucky Charms? You know, there's been some
companies that have said that they're going to aim to
do this by twenty twenty seven. So there's been movement,
(12:56):
positive movement. However, you know marsarticularly with Eminem's, they're saying
we're not going to get on board. They're fighting you
guys with it. Why are synthetic dies dangerous. And I
guess what are sort of the next steps that the
administration that you guys are planning on taking in regards
to that.
Speaker 2 (13:17):
Well, first of all, this has been a big issue
whereby Republican, Democrat and independent moms showed up in high
numbers to vote for President Trump over this actual issue
is very issue that President Trump and Secretary Kennedy have championed.
There are you know, we can learn from listening to
parents when parents tell you that their child had bad behavior,
(13:44):
or had attention deficit disorder, or had behavioral problems at school,
and then they eliminated all of these artificial petroleum based
food dies from the diet of their child, and then
the child suddenly improved to having normal behavior. That's not
a randomized control trial, but we as scientists can learn
(14:04):
that is a that is a data point, and in conglomeration,
these are data points we can learn from. There are also,
by the way, randomized control trials, for example, one in
the Lancet the Medical Journal Lancet showing that petroleum based
food dies were associated with attention deficit disorder. So what
are we what are we waiting for? Why do we
(14:25):
take risks. When we have an epidemic of child behavioral
problems and attention deficit disorder, why do we just blindly
go down this path of drugging our nation's children at
scale and not talking about the root causes. And personally,
I don't think kids need glow in the dark fruit loops.
I mean these are there are natural alternatives that can
(14:48):
provide color. And we went on the offense and approved
several natural food dies to replace these petroleum based artificial dies.
We're going to announce another one next week. But we
have been getting these natural dyes out on the market expeditiously,
and we took a bold step to ask companies to
(15:09):
stop using the nine petroleum based food dies in the
US food supply. I don't think the chronic disease illness
problem in American children is a will power problem. Something
is going on in the food supply. Now. On Mars,
you mentioned Mars, I think the reporting out there there
has not been accurate that I've been seeing about Mars. Mars.
(15:33):
Mars is a family owned business. They want to make
improvements in the health quality of their foods. We've had
very productive conversations with them, and we're going to be
meeting again with them. I'm meeting with them, i think
in the next week or two, and I'm optimistic that
they are going to join this bandwagon. Effective food manufacturers,
(15:55):
Craft Hinds, General Mills, dan O, and Yogurt, Jello, all
these products that have pledged to support Secretary Kennedy's vision
for a food supply for American children without these petroleum
based eyes.
Speaker 1 (16:10):
What would you say are the most important things the
Trump administration has done so far to make America healthy again.
Speaker 2 (16:18):
Well, we are rewriting the food guidelines, the dietary guidelines
that has been probably one of the greatest sources of
health misinformation in the United States in our history. You know,
the broken food pyramid written by the industry. We are
rewriting that right now at the FDA, and we should
(16:39):
have that out later this year. We have taken an
inventory of all the chemicals in our food supply. We're
doing things to educate the public about chemicals. It's not
just the petroleum based dies. One company took action, the
maker of Skittles to remove titanium dioxide. Another concerning chemical.
(17:01):
We are promoting whole foods and grains without the fiber
stripped off of the grain as we typically see with
ultra processed foods. You know, seventy percent of the diet
of kids now is ultra processed foods. So we're bringing
a lot of attention to that issue. And you're seeing
for the first time ever in this Trump administration, the
(17:23):
SNAP program changing, whereby states are being granted waivers to
no longer use taxpayer dollars to fund ultra processed junk
food and sugary drinks. We've got to start talking about
school lunch programs, not just putting every kid on ozembic.
(17:44):
We've got to talk about environmental exposures that cause cancer,
not just the chemo to treat it. And so the
NIH has a very aggressive agenda to now study the
root causes of chronic diseases, because up till now, most
of the focus has been just on this whack a
mole game of medicating and operating on people after they
(18:05):
are very sick.
Speaker 1 (18:06):
I know, I know that you have pledged to reduce
and you know, cut some of the animal testing requirements
and animal testing that's being done. What can you tell
us about some of these tests on animals and why
is that important?
Speaker 2 (18:22):
Well, a lot of the animal testing that's routinely done
for drugs that are being evaluated here at the FDA
are unnecessary and just to take a step back, Lisa,
I don't believe that God put animals on planet Earth
for us to abuse or torture, and so.
Speaker 1 (18:40):
We can crouch you would disagree with you.
Speaker 2 (18:44):
Continues. We can modernize the agency and use computational modeling.
Now AI technology that looks at a molecule and can
predict its toxicity in humans better than it animal test
predicting toxicity in many instances, and there's something called organ
(19:05):
on a chip technology where the drug is tested on
a cell culture medium or what we call an organoid,
a mini organ in a lab. We don't need to
be torturing animals and keeping them in captivity in many instances.
So we have an aggressive roadmap to reduce animal testing
that we introduced in one of my first weeks in office.
I've been in office, gosh, I guess one hundred days now,
(19:29):
this is the one hundred day mark, and so we've
had this aggressive plan to reduce animal testing, remove the
petroleum based eyes. We've got AI. Now for the scientific reviewers,
it's speeding up their process, and we have a pilot
program to reduce the decision time of the FDA from
nearly a year to just one or two months. All
(19:50):
of these things are aimed at modernizing the agency and
cutting the red tape so we can streamline the regulatory
process and deliver more cures and meaningful treatments to the
American people.
Speaker 1 (20:04):
Yeah, there's been one of the before we go, one
of the big lines of attack against the Trump administration
is you know, they're saying, you guys are cutting research
and it's going to put lives in danger.
Speaker 2 (20:16):
You know, et cetera, et cetera.
Speaker 1 (20:19):
Has our ability as a country to you know, do
various important health research regarding cancer or what have you.
Has that been impacted by you know, cutting some of
these grants.
Speaker 2 (20:31):
Well, if we're talking about the NIH, when Jay bid
Trina walked into the NIH and I talked to him
a lot, we're friends, and he walked into a mess.
Fourteen percent of ANIH grants were going to health equity
and diversity research. That was descriptive. It did nothing for
these disparities that we see in the United States. We
(20:53):
were funding a lab and a group that likely brewed
up the cronnavirus that killed twenty million people and cost
twenty five trillion dollars worldwide, and they had done very
little research on the root causes of chronic diseases as
(21:14):
the health of the population has gotten worse. I mean,
if you measure healthcare by sophisticated gene editing or operations
that we do in surgery, yeah, there are incredible success stories.
But if you measure the performance of the US healthcare
system over the last fifty years by the health of
the population, it's been a fifty year failure. And so
(21:36):
Jay Buddetarni is doing an incredible job, especially with all
the fake news out there about NIH dollars being cut.
Not one NIH dollar has been cut. There's not a
single dollar to the NIH budget that has been cut.
Medicaid has not been cut. There are reasonable limits to
(21:57):
the growth rate of Medicaid. And so there's a lot
of incorrect information out there on what's happening. But of
course it's from the usual, you know, fear minded reporting
on what's going on.
Speaker 1 (22:13):
Well, you've lived through that with COVID. So you're up
to speak with Commissioner Marty McCarey. Your friend just so
happy for you. Proud of you, and so glad you're
over at the FDA and we've got people like you
and government well.
Speaker 2 (22:28):
Thanks so much, Lisa, great to talk to you again,
great to connect. Thanks for having me.
Speaker 1 (22:34):
That was the FDA Commissioner, Marty McCarey and my friend.
Appreciate him for making the time to come on the show.
Appreciate you guys at home for listening every Tuesday and Thursday,
but of course you can listen throughout the week until
next time.
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