FDA Direct: 100 Days of Science, Common Sense and Radical Transparency

 All right, we're doing this. We're back.
And now we're going to have a fun time
today.
Sanjula,
great to see you and Sara Brenner,
the Principal Deputy Commissioner.
It's awesome working with you.
You've been here much longer than I have,
but I'm learning a lot. Yes.
Close to six years.
And we are excited that you're here. Cool.
Excited to have you here.
So today
we're doing a little bit
of a special edition,
celebrating the Commissioner's
100th day on the job.
Should I be nervous because you've got
a paper in front of you?
You should be.
I got some tough questions for you today.
Okay. You're interviewing us today? Yes.
So, in honor of the special edition,
we're going to mix it up a little bit,
do a little bit kind of interview style
with the two of you.
We have opened up questions to the public,
and so we received
hundreds of questions
just in the last hours.
So you should ask what she's up to.
I have no idea what she's up to.
Okay.
So...and I and I've been polling staff
around the, the agency.
And so in true research fashion,
I have tried to filter down.
We don't have enough time to go through
all of them
that I picked out a couple of themes
I thought would be fun to talk about.
So today we're just going to reflect on
on your first days and kind of where
where we're going from here
and maybe throw in some fun,
get to know you a little bit more.
Okay. Bring it on. All right.
So are these questions from people
here at the FDA
or any old Joe out there in the world?
Combination.
We have questions from parents.
We have from industry.
We have it from FDA staff.
A couple from Sanjula., got all of it.
Did Bigfoot contribute any?
I think Bigfoot did.
What are you going to have?
You know that actually was
one of the questions is when are you going
to have Bigfoot on the show?
Well, Bigfoot's busy,
you know, he's got like eight kids.
How many kids do you have? Bigfoot.
Eight. Eight little foots
or little big feet?
Little feet. Okay. Little feet. Eight.
We'll have to have the whole family on.
Yeah.
We're going to have we'll have
we'll have him in the orange chairs
or hopefully someday we'll replace these.
Very. Yeah. I think today
I'm blending in with the chairs.
We did not pick these chairs.
Yeah.
They were not picked for this podcast.
They were just sitting here in our lobby
and we just said,
hey, let's go out in the lobby
and just turn the camera on and just talk.
They swivel though, okay?
You can't dodge me too long
because I know I
twisted your arm to do this.
I, I know she's
starting with the hardest ones
first or the hardest ones last.
Well, Marty's so humble, I know.
Doesn't want to talk about himself,
but I think we've accomplished a lot
the entire agency.
We've made a lot of great progress.
So I guess maybe when you started the job,
what did you come
in with as your big goals?
Well, look,
I think streamlining the agency,
modernizing it.
I want to see more cures for everyday
Americans and other meaningful treatments,
more powerful diagnostics
that empower people to to get information
about their own physiology, their own
glucose levels, their own, physiology.
More...better processes
to do all of these things.
Healthier food for children, sound
inspections,
equalizing the playing field between
foreign manufacturing
and United States manufacturing.
I don't think it makes sense
to put American manufacturing plants
through a wringer of an inspection
and then just have scheduled,
announced inspections overseas
that are less frequent.
So I'd like to see more domestic
manufacturing.
I'd like to see more domestic production
of drugs as a national security issue.
I'd like to see us support
national priorities.
I'm sorry.
I think my phone here...
ah, it’s just the Secretary.
I call him back. So,
there are
incredible things you get to see
in the pipeline in this job.
Yeah, that's an ambitious agenda. Right.
So you've already started chipping away
at that.
In the first days, what do you
what would you say
some of the biggest accomplishments are?
Well, the AI thing has been well received
broadly throughout the agency.
That is that we have now a powerful
AI tool for our entire staff.
And we're tracking ...it's optional.
They don't have to use it
for their scientific reviews.
We're tracking the scientific reviewers
and others who are using it.
And thousands of our staff
are using it every day.
So we think they must find it helpful.
We just, sort of upgraded some of
the models to make it more powerful.
And we're going to be releasing
a sort of version later this month.
So I love the AI tools
that now are available to the,
to the staff...Piloting
new pathways...that's exciting.
I mean, it's going to be really 
interesting to
work through this new pathway,
whereby our goal
is to get a decision in a month or
two instead of nearly a year.
Reducing animal testing,
using some common sense ideas
that come from within the agency.
The CEO listening tours provided
some really formative
feedback on some things
we can do to improve communication
and reduce the amount of guesswork
that companies are doing.
Trying to mind read
what the reviewers might want.
And, as you know, we released
the CRs, the Complete Response Letters,
the Complete Response Letters,
which are sort of for the lay public,
the Rejection Letters.
These are the decision letters
for drug applications.
And so it allows inventors
and drug developers to understand
exactly how a particular study group
thinks, right, and what to expect
and what the statistics are on
why applications get rejected.
And it helps, I think markets.
It helps inventors.
It helps strike developers
with predictability, Markets
like predictability.
We can have a whole conversation
just on that.
And I think, you know, petroleum based,
taking action on petroleum based food
dyes was another big one
that happened in your hundred days.
Yeah. Nonstop effort...
The list keeps is so long.
So you have to the public will have to go
check it out on the website
if you're interested in all the details.
But there's another personal,
accomplishment.
I guess we could call it an accomplishment
in the last days to you,
if you're comfortable sharing.
Are you talking about
the Ravens picks in the draft?
That too.
But you also welcome the new family.
member. Oh, yeah,
we've got a newborn baby at home.
So that's, surgery internship
all over again.
Of course.
It's been a busy hundred days for you,
that's for sure.
So, you know, you both embody
a lot of the MAHA lifestyle.
But, Commissioner, I'm curious.
How do you. You know, what do you eat?
What's your workout routine?
What's your MAHA lifestyle?
Well, for being honest,
it's always a struggle.
Always trying to get the workouts in
and eating healthy.
It's always a struggle.
But, I try to get to the gym most days.
Now you're a big runner.
If I remember.
I'm not a runner.
I. I'm a walker.
But you...It's a form of addiction.
We'll be honest with you. No, but, Yeah.
So, I mean, running, in general,
cardiovascular and strength training.
It's a great way to clear your mind.
At least for me.
I do some of my best thinking
and have some,
you know, some of the best breakthroughs
when you're.
When I'm listening to Audible and books
and things like that, going for a run
or even conversations running.
So we've we've tried to kick off a variety
of activities for folks on campus
to do that as well.
Oh, like to run club? Yes. Yeah. Yeah.
Really? Yeah.
So there's a fitness center here.
Oh, yeah. I used it this morning.
Yeah, yeah.
So in a previous...
I’m not bragging it's,
we had a TV crew here and they're like,
oh, can you show us the gym and do some,
you know, bench presses?
So I looked like a fool out there.
But I try to do...
Are you going to do a pushup contest?
Yeah.
How much can you press?
Well, not a lot,
but the Secretary actually can bench press
more than me at the age of 
That's his age of 
Not mine, but, 
we were supposed to do it where the anchor
was going to do some bench
presses, and I...
I was going to do bench presses,
but then he said, oh, it's at of
and we're out of time when it was his turn
so it was convenient.
Convenient.
Yeah.
In a previous life
I led an occupational health program.
And so, you know, in some of the things
we've been talking about in terms of
improving the function of the agency, it's
investing in the people that work here
and helping them
not only to do a good job, enable them
through technology and improvement
and processes,
through listening to them
and incorporating their ideas,
finding examples of things
that are working really well here
and amplifying them, but also,
do you want to work here?
Do you enjoy working here?
Would you recommend working here? Right.
And so the first hundred days
have been outstanding
and I get excited
just hearing about all of these.,
you know, when we go back through the days
go so quickly, you lose track of
how many things you've broken ground on.
But the first days at least,
mine started slightly before yours
in the Commissioner's Office,
not the agency,
but there were a lot of challenges,
too. Yes.
Right.
And so, you know, we recognize
and we spend a lot of time
and I know Sanjula, you and others
talk with us as well
about, how we can really, truly listen
to some of the challenges and difficulties
that people have coming out of earlier
in the year.
Yeah. And modify processes. Right.
And really invest in the workforce,
because FDA is only as good
as the people that work here
and the processes that they use
to do their job and the evidence upon
which they're rendering decisions.
And so when I hear, you know, your
reflection on list of accomplishments,
I hear themes having to do with quality
about transparency,
and about truly honing in on
and focusing on FDA's core
mission and empowering the people
who are responsible
for carrying it out on a daily basis
to do that.
So anyways, we started with running,
but it's one example of a way in which,
you know, we can walk the walk and talk,
you know, not just talk the talk,
but we were both big,
you know, MAHA people,
in terms of healthy living,
prevention, lifestyle,
good decision making, empowering people
to make evidence based decisions
in their personal lives
and their health journeys.
But also, how do we do that at work?
How do we do that at home?
How do we do that in a seamless way
in all the aspects of our lives?
I think it's important to recognize that.
I guess we'll keep going
while he takes that call.
Go ahead. Okay. Well, so we're rolling.
We said it was going to be said
no matter what happens.
Yeah,
because this is what happens day to day...
duty calls. Yeah.
So since you have,
seen been with the agency
through leadership changes, different time
periods from your perspective,
what is different about the last days?
And you know that this Commissioner.
Right. Like, what have you seen?
What are you excited about?
Yeah, well, there's a lot.
But if I were to try to just kind of
put it in categories,
it would be the rate of change,
which is like being shot out of rocket,
quite frankly.
And the level of ambition, for change.
And maybe there's a third category
and it's something like,
ruthless pursuit of, truth.
There's more to it than that.
But in any event, I think this has been
a time that has been very unsettling
for people in good and bad ways,
like the full spectrum.
A lot of folks in government
choose, civil service career
because they like predictability
and stability, and they're willing to make
a tradeoff in terms of their compensation
for those things.
So I recognize that
I've worked in the civil service
now for six years here and two years
before that in the White House.
So it's hard for
people, this rate of change,
and the unpredictability
is also difficult.
And so, we recognize that and at the same
time, kind of, like remodeling a house.
I don't know if you've done a renovation,
but it seems like it always gets worse
before it gets better,
whether it's cleaning a closet or,
you know, whatever it is that requires
quite a bit of overhaul.
That's what we've gone through
and that's what we're going through.
And we don't,
you know, have to be comfortable with that
for it to be the right thing to do.
And I don't think there are many people
at FDA or in our sister
operating divisions or the Department
who would say, everything's perfect
the way it is, like, we've got it all
figured out here, right?
We don't need to change anything.
There are are notorious challenges
that FDA has had and that HHS has had.
The whole government, actually.
But, you know,
at this moment in time, we're saying
we're not going to do business as usual.
We're not going to spend years
chipping away or nibbling
around the edge of the sandwich.
We're really going to go for it,
and we're going to go for it
in a way that maybe has been
needed for quite a while.
And,
that's going to be disruptive.
Yeah.
But, you know,
the hope is and my true belief
is that on the other side, we will have
I'll speak to FDA now, specifically,
a regulatory agency that's truly
the gem of the world for what we do.
We have, you know,
boasted of that reputation in the past.
It has been very difficult
the last several years,
especially through Covid
in terms of public trust, in terms of,
you know, our processes have not kept pace
in terms of modernization or technology
use, has not kept pace,
from a modernization standpoint
with industry and the private sector and
sooner or later standing still or making
little steps forward, you're behind.
And, folks, see that here.
We're
really serious about fixing those things.
And as we were saying before, going to
where the puck is going to be
and not where it is,
because in, in this job where
we're regulating medical products
that are on the cutting edge
of technology, that are convergent,
you know, between different types of tech,
digital devices, you know, regular medical
or more conventional medical devices.
drugs, data, etc., you have to keep pace.
Very well said. Yeah.
So that's really the spirit
of what we're trying to do.
And that's not to minimize
anyone's level of discomfort
with how fast it's happening.
We really, are hoping that and,
and we've talked before about ways
that we're looking to engage
frontline review staff, managers,
more senior leaders
at all levels of experience across FDA
to gain their perspectives
and their buy in as we chart solutions
and we try to construct solutions
that will be implemented, at the ground.
And that's really the only way to succeed.
I think part of what you may be referring
to, as you know,
you and the Commissioner decided
to do the kind of like a medical reviewer
listening tour of sorts.
Is that. Tell me more about that. Yeah.
So that's one, initial way
that I'm looking to gather feedback
from frontline review staff.
So the Commissioner
will probably not go to all of those.
There will be many of them.
But the goal is really
to create an environment
with small groups of people
who do our frontline review work
so that they're comfortable
sharing, ideating, you know,
coming up with new and old ideas,
because a lot of ideas
people have had for a long time,
and they just never gained any traction.
Right.
But how can we how can we prioritize
different actions that we can take
that will dramatically
and in a very quick way,
or maybe some will be longer
construction projects, but start,
start, optimizing
the the way that people do business here.
So the Reviewer
Listening Session is one way to do that.
And I'm hoping that people are very,
you know, brutally honest.
They have been with me
so far, where I'm not just
going to go around and
listen to all the things that are great,
but the things that are really challenging
that we have opportunities.
Yeah, change is hard.
But as we get on it, I love
I love your home renovation.
Yeah....analogy that you know, I
sometimes
when I had this quote up on my desktop
during Covid for so many years,
it's like the only way past is through.
You have to go through.
And that's what we're doing now.
And, you know, again,
it's not to minimize or not
be empathetic with the difficulty
that that presents to people, but
we'll get there. Yeah.
The other thing
that I hope people don't lose sight of is
there is a lot that was great about FDA
before this administration,
in previous administration,
you know, under under various, leadership
styles.
The agency has,
really tremendous strengths.
And we've been able to recruit top talent.
I'm very interested in retaining
top talent and recruiting more top talent.
So it's it's not just about smash at all
and build something new.
It's also what's worked really well.
And how do we preserve and amplify
those things,
learn from those best practices
and best examples.
So I think it's important
to not lose sight of that as we get
caught up in the, you know, sort
of the excitement of building new things.
You're
talking about the Commanders draft picks.
We can’t talk about that without you.
Okay.
Oh, good point. Yeah. Yeah.
So you're a Ravens fan though.
Yeah. You know, but they're all winners.
They're all God's children.
So I support all players.
What did you think of that last season?
The Ravens?
Yeah.
Look, I think it was it was tragic that,
Zay Flowers injured his knee
and couldn't play in that postseason game.
We lost to the Bills by two points.
You know,
so there's a lot of what if thinking.
But they're going to be strong this year.
Basically everybody's back
and they got some good new picks.
So I'm feeling good...feeling
good about things.
Commanders, too, look they look strong.
If they can get a deal with, Terry
McLaurin, that contract's up in the air,
as you know.
He wants a lot of money,
and maybe it's an appropriate amount.
I'm not going to make a
comment on that, but,
But they're in some contract dispute.
Yeah, I think he's getting fined
every day.
He's missing out on their mini training.
So, Yeah, a lot's coming down right now
with Terry McLaurin.
A lot's going down.
Are you one of those people that counts
down to the start of the next season?
No I'm enjoying
like I loved watching the Thunder,
and it was just a great run
of, of great professional basketball.
And Oklahoma deserves a win.
So, now I, you know,
I'll turn on whatever's on and support
whatever team is, is playing the best.
Sara? Who's your team.
Well so I grew up in the Midwest
and baseball was my lullaby.
Right.
So my dad played baseball
and he coached baseball for decades.
And so I kind of grew up
with just the sound of baseball.
Although football is big in the Midwest.
But I'm a basketball person,
so I can't say we've got it all.
We've got it all covered.
But now I started watching hockey as well
in the last or years.
I love sport, I love watching sport.
We already talked about running.
That's more of a solo sport for people.
How far do you run each day?
Well when you run.
It depends on the day
you run. You run most days?
I try to, I try to either do
strength training or running.
Yeah. Every day.
I used to be a little bit crazy
and do the ultra stuff...Get out
milers plus. Wow.
But you know my goal
now putting my yoga to shame here.
Yeah, I'd like to run until I,
you know, die.
Right.
And so I can't do that
if I burn out my joints...
So you love it. Yeah, I love it.
Are there any good running
trails on campus here?
There are some good routes. Yeah.
So that's part of what we're trying to
gain, you know, some little footholds
with the invitations for people to run
and show others where they run and,
create little maps of where they can go.
And it's also a great way to get folks
to meet each other
who would otherwise never meet each other.
I mean, this is a massive place.
There are a lot of people here in
what are we at some thousand now.
And, in our effort
to collaborate more across the centers,
another way to do that on a ground up
way is to just have more opportunities
for people to meet each other
and share activities together.
And if they're sharing healthy activities
together, you know, that's even
even better.
So you talk when you're running,
you're one of these people
that's like,
I can't talk, I'm focused on my running.
Or I listen to audiobooks
because I'm like a a book geek mile.
I mean, I'm that qualifies
as a high risk behavior in medical terms.
Yeah, I did have more
injuries than I wanted to have when I was
when I was training at that level.
The relays were fun too, though.
I did a mile relay in Vermont
and through the mountains,
the Green Mountains.
And that was a lot of fun, because then
you get to share the pain with others.
Right?
before you get another call, go ahead.
We're trying to...
I know you're you're stalling me here.
So I have no idea what's on your sheet.
That gets a little nervous.
Okay, so we're kind of on fire.
I'm sprinkling in some questions
we got here.
Okay, so while you were taking a call, 
Sara and I were talking about, you know,
we have to.
we can't be left behind, right?
We have to to modernize
and do all these things. Yes.
So one of the questions we got is,
do you worry that letting China copy U.S.
IP and run Phase One
studies is slowly destroying U.S biotech?
Yeah,
I think about China almost every day.
I mean, it says there's a significant,
threat not only in terms of regulation,
but in terms of innovation and keeping
America's position first in the world.
I mean, we're seeing companies now
essentially,
allowing IP from the US Patent Office
to be tweaked or copied or,
used for drug development
for a new molecule
or new patent or a new variation.
And then that goes through
preclinical IND
and Phase One in China in lightning speed.
For those of us
who may not know what is IND?
Ah, Investigational New Drug.
So that whole process to get that status
and then
that entity is then getting purchased
and then run through the United States
regulatory process, and who's buying
some of those entities, United States
pharmaceutical companies.
Now, we can say, like, this is despicable
and we have to set up, protections.
But I think the foremost thing
that we need to have come to mind is
how do we create a regulatory process
that's efficient in the United States?
Because it's not just one country.
We're seeing...
We have competition
like we're a regulatory body,
and we're a country with inventors, and
we've got competition around the world.
So we have got to, you know, when
in our animal testing reduction plan,
we learned that we were still requiring
routine animal testing
even after a drug was approved in Europe
and used in thousands of humans.
So those are things where we can say,
let's look at the real world evidence,
let's custom-tailor the approval process.
Let's be creative, let's be flexible.
Let's we've been doing it with rare
diseases.
We're doing more of that
with rare diseases
where you just
can't run a randomized trial.
So I think we have to think creatively.
And that's one of the reasons
why I love my one
on one time
with scientific reviewers here at the FDA.
And you've been doing that too.
You've been meeting with them
and you hear ideas
and you hear new ways of doing things.
And look,
some of those ideas are not feasible,
or there's nothing that ideas
we can't act on right away,
which you learn, and so I think
there's a lot of great ideas
that come from within the FDA.
I love the career staff here.
I've been getting to know more
and more of them.
It's the best part of the job.
Has anything surprised you about what
you, as you gotten to learn the work
and the agency? What has stood out to you?
I mean, just how hard it is to review
these giant, gnarly applications.
And when you learn about this intense team
effort to go through all the details,
it makes you want to go back to the office
and think, how?
What can we do to make our
AI reviewer tool better for them
so they can find more value in it?
What can we do to make their lives
better here on campus, be it a farmer’s
market or extending food hours or, 
unclogging some of the bureaucracy
that they've had to deal with,
with some of their own, stuff.
So...
I think this bigger orientation, though,
you know, coming from private sector,
it's important
to think about that competition.
And we have to compete
and we have to stay ahead. Right.
We I think in government
we don't think enough about that.
But to do that, you're having to challenge
the status quo.
We talked about this earlier about
modernizing, which is really hard to do.
Right.
And you've got to really think about it.
So I'm curious, you know,
you were one of the only,
health officials
that you were THE only health official
that had the most bipartisan votes.
And, you know,
you've really thought a lot about,
you know, your agenda,
what you were going to do coming in.
How did you prepare for the job? Right?
What were you reading?
What what kind of conversations
were you having to be able
to hit the ground running
and to get all this off the ground?
And, you know, just first few days.
I started going on mile runs
for the first time in my life.
That's great.
You can join our FDA running club,
mile runs maybe, but not 
You know, I was in the operating room
the day before my confirmation hearing,
and I've thought a lot about big ideas
for the FDA.
It's been a lot of my career
and health policy, but I was really eager
to get here, to talk
to people on the ground in more depth,
in a safe place where they can
just explain their big ideas.
So, I think there's just so many cool
opportunities.
I think the way you really, lead
an organization
is to work harder than anybody
within the organization
to show that you're committed.
And I think you listen to people,
and people want to feel heard.
When I worked in a gigantic hospital
system,
my primary way in which I felt valued
is when I felt heard.
We were all ready to work hard.
We'd work so hard.
But when you felt unheard,
that was a bit of a helpless feeling
and it didn't feel good.
Yeah.
And I've observed Marty doing that.
A lot of people come in
and out of the Commissioner's Office
and you're out on campus
talking to people all the time.
You've been taking more meetings
than I because, you know, I'm one person.
I've got a lot of responsibilities,
but you've been spending a lot of time
meeting one on one.
And even with small groups
without their managers. Yeah, yeah.
So they don't say thanks to the leadership
of my great manager.
That's wonderful.
And we do have great managers here.
But we want to hear like raw, 
unfiltered feelings about the processes
here not to know where you're at on a hunt
to get people in trouble.
We are on a hunt for great ideas. Yeah.
And you are certainly listening.
You said another thing about working
really hard.
You know, I always get questions
from friends and family.
It's like, what is it
like working with the Commissioner? Right.
And that part is so true.
You are in the trenches, right?
I don't think a lot of people know this
about you, but you are a prolific writer,
a great communicator.
You've been writing all these Op
Eds...You've been doing,
I don't even I've lost count
of how many media interviews
on top of being here,
walking around and taking meetings.
I mean, you are in the thick of it,
and I mean, you do.
You do all of this yourself.
I mean, it's really amazing.
The other thing.
Yeah, the other thing that's outstanding
is it's not just idea, it's action.
Right.
And so, this is part of what I think
is a great moment,
an opportunity for a cultural shift here
at FDA to have greater
transparency, more communication, idea
generation.
But action. Right.
And there are several instances I won't
give the specifics where, you know,
the first day you were here,
the first two days you were here, I said,
these are
the three things that are on fire.
We need to take action.
And you said, go, go, go.
And there were some fires.
There's plenty of fire.
It was a rough time to come
in. It's a very rough time.
And there were 
things that needed done.
But we prioritized.
And you did not hesitate.
Once you understood
and got the information, it was like,
we need to fix this
because the people here
need us to fix this
so that we can do our job
so that we can fulfill this
critical mission that no one else has.
It's ours alone. We cannot fail.
This is like a zero failure,
you know, situation.
And so, yeah,
I don't see that in government a lot.
I don't see it very often.
So, you know, you talked about
what's different this time around.
Yeah.
With the change in leadership at the FDA.
And what we had said,
you know, were a couple of things
having to do with the pace of change
and the appetite for change,
and then taking action
like decisive, bold action
that, has been needed, quite frankly,
for a long time in a lot of areas.
And it we've, we've lacked
that sort of the vision
and then also just the chutzpah
but to pull the trigger.
So let's be very blunt.
It was a difficult time just before I came
in, there was a lot of early retirements.
There was some reduction in force.
There was there were a lot of changes.
And there was also some uncertainty
about whether or not there was going to
be a big reorg, whether or not there
were going to be more reductions in force.
And, so it was a challenging time
and people were hurting.
There were people here
that had lost colleagues, that lost people
that supported them and their roles.
And so we did a rapid assessment.
We did, a mass reinstatement.
We, posted jobs quickly and, 
all with it's hard to believe
it's only been three months or so
since I've come in.
We've gotten hundreds of jobs
now approved to be posted.
So if you're interested
in coming to work at the FDA,
we are hiring scientific reviewers
and a whole host of staff at USAjobs.gov
I don't know if that's the website.
Sounds good. Yeah.
But if you Google USA jobs,
you'll see a lot of jobs posted
and more that are about to be posted.
And so we're healing a little bit
from some of that change.
But this is an incredible place
and we are trying hard
to create a great workplace culture.
We've got one of the best
brands of any brand in the world.
We've got a gorgeous campus, we've got
phenomenal people that work here.
They've been working here for a long time
that love their jobs,
that when you see them,
they're just smiling and beaming
and they want to tell you
about some incredible,
thing that they just did
or were a part of.
We have fellows and visitors
who come through here,
and they're just blown away
by the professionalism, by the,
scientific depth, by the talks
that we have,
by the continual
learning that we engage in.
So it's an incredible place.
And my goal is for us to create
an amazing workplace culture that people,
love, where they love going to their job
every day.
When I was a surgeon, every morning
and when I went to work, I thought,
how amazing is it that I get to do this?
And I can't wait to arrive
at the hospital.
And in this job I feel the same way.
And my goal is that
everybody will feel the same way here.
Yeah, you asked about competition
and I think about this
a lot with regard to workforce.
I was a faculty member
before I came to government,
for ten years, and I love recruiting.
I loved recruiting students.
I loved recruiting other faculty.
And since I've joined the government,
I also still love recruiting
and building the workforce
and all those things you said
I feel that exact same way.
We want this to be a place
that is the employer of choice
for top talent,
and we are competing with industry.
We're competing with other,
you know, private sector
employers, with nonprofits with
I mean, there's a fierce competition
for the type of talent that we have at FDA
physicians, PhDs, dentists,
you know, other types of scientists,
every type of personnel.
There's a I mean, we,
we have our job cut out for us.
We always have. This part is not new.
Competing for top talent.
And...But the impact, it's so rewarding.
It's rewarding.
We're hamstrung in a few ways.
I mean, obviously, in terms of pay,
the government doesn't pay
as much as is private.
But the rewards of doing the job
and doing a job
well and the impact it has on patients
and physicians and the general public
and the whole of the country
that is the tie that binds
all of the people here at FDA.
And it's really it's
completely apolitical work.
I mean, regulation should be always
apolitical work.
And that, you know,
that is the type of spirit and culture
that we hope to foster
continue fostering, really.
So I want to shift gears a little bit.
So I have spent a lot of my career
working with CEOs of
organizations, health systems,
pharma companies, you name it,
that are multibillion
dollar organizations. Right?
I think a lot about, you know, I've
learned how they think, how they operate.
But I would say and working and observing
all of them, even publicly traded
companies, don't have the same level
of scrutiny that I think, Commissioner,
you have in this role.
I think of you, you're effectively
a CEO of this organization.
And, you know, every day there is hundreds
of articles and headlines about you,
you know, many positive.
But there's always criticisms, right?
You're always under the public eye.
How do you personally emotionally deal
with that?
Like I think controversy is good.
I think the different opinions on the FDA,
those
that's a good civil discourse to have.
We want to hear people's ideas.
We also live in a very partizan time.
So I think on average, on the whole media
coverage has been good, representing that
good work that's done here by the, 
many people here at the agency.
But there's always going to be some noise
that's not true.
Things that are just not true.
You're always going to find
some,
individual or individuals
that are very unhappy.
That was true at Johns Hopkins.
It's true at large organization.
And I think it would be wrong
to characterize
that culture broadly
by the opinions of a few people.
So, our job is to always try to do
better, block out the noise.
I personally do not read the headlines,
although
Sara does read them for me
and give me a little summary.
But, you know,
I'm trying to stay positive.
I'm trying to I'm trying to do
the very best we can.
We should have increased scrutiny
because this is a taxpayer
funded government organization.
It belongs to the American people.
It doesn't belong to industry,
doesn't belong to us.
It belongs to the American people.
So I do welcome that. Now,
some have
said, you know,
when there was the reduction in force,
that was far less than a %
of the workforce being laid off.
Southwest Airlines
announced the same week that
they were going to reduce their workforce
by %.
Not a wink from anybody.
Nobody said there's going to be safety
concerns with travel.
And of course, no scientific reviewer
or inspector was laid off
as a part of that reduction.
But still we had to go back
and do an assessment,
figure out how to, you know,
streamline things.
So, you know,
we're still close enough to that where I,
I think it's it's
healthy to talk about it. Good.
We're going to get to a point,
I think, where,
we're just going to be looking ahead,
but we're still continually
doing an assessment.
And when we think we got it right,
we do another assessment.
You’re a surgeon, you're so precise
and you're always,
you know, making sure you get it.
So...Repeat until perfection. Absolutely.
So I know I have to race against the time.
But before he gets his next phone call.
So I want to get into
maybe I'll call a rapid fire.
And so a bunch of questions
we got and try to group them a little bit.
And either of you can can answer.
But one of them is will
this administration
put an emphasis on delivering treatments
for patients with long Covid
like, I'd love to see a clinical trial
that shows a benefit of a therapy
for patients with long Covid.
For individuals with long Covid.
I'd love to see that data.
Yeah, we are getting a lot of questions
of, you know,
what is the FDA going to do
to fill a substantial
unmet need in treatment options
for fill in the blank disease?
Right. And there's a whole list
of different diseases.
How do we solve that?
There are a ton of diseases
that are terrible.
And so, I think we get into trouble
when we start saying,
well, this disease is the most terrible
because I have an aunt
who suffered from it.
I think Alzheimer's is a cruel disease.
I had an aunt who died of Alzheimer's,
but it would be wrong of me to say,
we're going to make that a priority over
ALS, another debilitating
neurodegenerative disease.
So I think we have to stick by our
commission from Congress,
and that is a charge to evaluate
data that is presented to us
and to deem what is safe and effective.
When it comes to drugs
and devices, food is a separate issue.
And our law enforcement and inspection, 
piece of the FDA is another story.
But that is a charge that we have,
and it's a charge that we
try to uphold every day.
Of course, we have to customize
that regulatory process to
conditions where you can't.
It's not feasible
to do a randomized trial,
but I think that is our charge.
And we've got a lot of teamwork
with other parts of the health
care system where we can say, you know,
we think this is the future.
We'd like to see more in this space.
We're going to streamline the regulatory
process for, say, for example,
AI empowered software that provides
information to clinicians or patients.
Yeah. Yeah.
We're getting a lot of questions
from parents concerned about vaping.
And so I would summarize it
by saying the vast majority of vape
sold in the country are unapproved
flavored, kind of coming from China.
The FDA has failed to stop this
for many years.
What will change to address
this problem? Number?
This is a top problem in the United
States, and a top priority for us.
Kids who are not
using combustible cigarettes
that start on a vaping product
and become addicted to a vaping product
with an illegal Chinese vaping product.
This.
This is a major problem
in the in the United States.
So there's a couple things we can do.
One, we're doing a major crackdown.
We're looking at all
the ways that we can block, confiscate
and destroy illegal products
coming into the United States
at our ports and across the border.
Number two, we need to
work with retailers to let them know
these are the approved FDA devices
for vaping.
They are not devices with cutesy marketing
for children with fruity flavors
and other things.
These are, the FDA approved products
and everything else is not approved.
So we need to provide clarity to them.
And we do have a list, so that they know
these are the legal vaping products.
These are the illegal vaping products.
In some of these vaping stores,
the majority of the products are illegal.
We need to work on the distribution
networks of those illegal products,
and we need to educate the public.
So there's a lot of work
that needs to be done.
I don't say these things lightly, like,
oh, here's, you know, our talking points.
This is a major, major
focus of this FDA right now.
We have had an incredible number
of parents,
friends of the FDA,
friends of the leaders of the FDA say,
hey, at my school,
you would not believe the number of kids,
good kids from good families
who are addicted to these vaping products
and they started vaping from scratch
underage.
This is something we can address.
And it's not just vaping, it's H,
which is a synthetic concentrate,
a byproduct of, kratom,
which is a agonist of opioid receptors.
It's literally
binding to those opioid receptors
and creating some of that effect.
It can result in addiction.
It's gas station heroin.
It's a lot of these products now where
we haven't really fully understood them.
And when we don't understand
new public health interventions
or new public health threats,
we get behind the eight ball in medicine.
And time and time again,
we wake up when it's too late,
be it cigarettes through the s
and s in the medical field.
Woke up too late.
Be it the opioid epidemic.
When we woke up years later
after the approval of OxyContin,
and realized we may have lost
a million Americans from this.
And so, we need to get ahead
of a lot of these addictive products.
And right now,
people don't know what they are.
They don't know the research,
they don't know the data.
And the FDA has even, you know,
sort of stumbled trying to understand it.
Because we may be in the infancy,
I think, related to what you're saying,
you know,
you're also trying to get the agency
to be more proactive
in a lot of these different initiatives.
Right?
So shifting gears a little bit, we,
we've got some questions
about the food policies
and what we're thinking there.
What is happening with grass, and
will we start to see stricter food
ingredient regulations like the EU?
So grass is a
big focus of Kyle Diamantas
and our human foods program.
We're doing a lot
through the formal process on grass.
We're also working with Congress
where, doing an inventory
of all of the chemicals that appear
in the US food supply that do not appear
in the food supply of other countries
because these substances have been banned.
We're, reviewing all the scientific
available literature
on these different substances.
There's a lot of them.
There's over a thousand.
So we've got to sort of do a proper
cataloging of all of these chemicals
and then figure out where can we start
and where can we start by using
honey instead of fire, asking companies
to remove these substances.
You may have heard
the maker of Skittles has announced
they're no longer going to use
titanium dioxide,
one of the chemicals
on our inventory list.
And so we can start seeing
some incremental improvement,
look when you get rid of petroleum
based food dyes,
kids aren't going to all suddenly be
healthy.
We're not going to address the fact
that % of our nation's kids
have prediabetes simply by removing
petroleum based food dyes.
But these are steps in the right
direction, right
steps towards those broader goals
you mentioned at the beginning, right
and this is just the beginning.
It's only been days, right?
And we've got a lot more to do.
So as we kind of close.
So where are we going from here?
What do the next days look like?
I want to keep seeing modernization
at the FDA, not just in,
how we support
our scientific staff here
with things like the AI tools,
but in the processes
and examining every process we have here.
And this requires a lot of rolling up
our sleeves, understanding.
It's sort of like being on the,
you know, you know, on the ground
where you have to figure out,
well, this person signs off
and then it goes to this office.
Well, then, where does it go after that?
And how long does that person I don’t
know...Are they staffed appropriately?
And you're doing a lot of this.
You've been at the FDA for years.
So you know the people.
And Sara has been helping us
tremendously do a lot of this work.
People ask me what Sara Brenner up to,
and I say she is on the ground out there
talking to people
and workshopping a lot of these processes.
It's not glamorous work.
It's not how for high profile work,
when you come up with a new process,
you improve the morale
locally within that department,
and you create a more streamlined system
that addresses one of our bigger goals,
and that is tackling the giant question,
why does it take over ten years
for a new drug to come to market?
Do we really think in the modern world,
if a scientist at a university
invents a cure for breast cancer,
that it should take ten years,
but that we need ten years
to be sure before we.
If you can notice a complete pathologic
response,
that of a tumor from a drug
with a very high safety profile,
do we
really think that should take another
five years until it comes to market?
So I think we need to reexamine
some deeply held
assumptions about the processes
that, let's be honest,
they were developed in the s
and some of them have not been updated.
So I love that idea.
I love the ideas
we're getting within and outside the FDA,
and we've got some big reform ideas
that we talk about that are in our brains,
that we're hoping
to bring to reality soon,
that we can't really talk about just yet.
Sara, anything high level you want to show
that you're most excited about?
The headlines you know are fun
because people get excited
and we can share with the public
what we're
what we're doing that
the public really cares
about within our mission space
and with our sister operating division.
So the interagency work always has excited
me since I've joined government,
so you can think big and pull levers
at the same time to affect maximum change.
But, some of the most exciting things,
honestly, to me,
are really under the hood.
They are the things that Marty
was just talking about.
These are, from my perspective,
as a civil servant and a career,
enduring change at the agency
is what motivates me every day.
It's why I've stayed here.
And when I think about
how is this place going to function
more efficiently,
be more nimble, be more future ready.
And, you
know, continue to recruit and retain
top talent in a way that is far better
than any of us could have imagined now
or previously when I joined six years ago.
That's what that's what motivates me.
And you probably won't see
headlines on that.
You know, on all the process in there
deep, you know, into the,
you know, optimization of electronic
input systems and data, analysis systems
and sharing of those types of tools
amongst frontline review staff.
That's not going to be on the news
most of the time.
But what will the results of that be?
The results of those improvements
will be faster cures to patients.
The things that Marty's talking about.
Right.
Harmful or dangerous products
not going to market or coming
back off market more quickly.
This is the core of our mission.
This is what impacts
patients and physicians
and the whole citizenry every day.
A lot of it is taken for granted.
And when you yeah, when you see FDA,
functioning really, really well,
sometimes that goes unnoticed.
Just like public health in general,
when FDA is not able to do our job well,
everyone suffers.
And so, you know, if there's something
I hope folks take away from this fun
conversation, maybe it's a little bit
more serious than the fun one.
It's that everybody in America
should be cheering for FDA
to improve and for us to do our jobs well.
And you asked how hard it is for Marty
to come in and lead this organization.
Well, unfortunately, we live in a world
in a hyper politicized environment
outside of FDA where they
they cheer on failures.
And that that and I just desperately hope
that everyone
can understand that what we do
here is in service of all Americans,
and everyone wins
when we're stronger, right?
Yeah. Thank you for saying that.
I mean, I have two more pages of questions
that I want to look at.
You see what you these are hard questions
coming from within.
I told you yeah, we're going to be okay.
They're here okay.
So we'll also I'll save
the rest of them for later and we'll keep.
They told me she has some hard questions
and I said okay.
Yes, but what?
We'll land on a more fun one.
So I hear National Ice Cream Day is
is coming up I believe next week, Monday.
Yeah.
So, Commissioner,
what's your favorite ice cream flavor.
Oh I thought you were going to ask
what am I doing for it?
I was going to say I'm going to celebrate
with the Secretary
and Secretary, Brooke Rollins,
and we're going to enjoy some ice cream.
As you know, a lot of the ice cream
companies are saying
we're no longer going to use
artificial petroleum based food dyes.
So I'm going to take an extra scoop
of those, brands.
And my favorite flavor, maybe vanilla.
Is that okay to say
that I like a particular type of
I mean, I like it
when it’s got kind of that popsicle
with the chocolate around it,
but I chocolate has a little caffeine
and I'm very caffeine sensitive,
so I can only have those in the morning.
And it's weird
to have ice cream in the morning.
So I really don't eat ice cream.
You can keep my husband company.
I make fun of him
for only liking vanilla.
So in...Fantastic. Sara, what about you?
Well, every day is ice cream
day for me. I'm a huge fan.
I'm a huge fan.
I like to make homemade gelato
or homemade ice cream. Oh, wow.
But I don't know if there's even a flavor
that I don't like.
I'd have to think hard
if there's one that I don't like.
But what's your favorite though?
Oh, boy. Mint Chocolate chip?
Moose Tracks. Ooh, okay. Yeah, yeah.
I was going to ask you any,
any mixins and your vanilla.
Well, because, you know,
I too labor intensive.
If you ask my family, they'll tell you
if you ask her what she wants,
she'll say a little bit of everything.
And that's true.
I have a hard time choosing.
So it's like a little,
you know, or different vibes.
Yeah.
So, but probably
if I just had to pick one,
it would be Moose Tracks
because it's got everything already in it.
Well, Commissioner,
maybe we can get like an ice cream stand
at the farmer’s market.
Like some healthy ice cream.
We want more farmer’s markets.
The farmer’s markets here,
which is every week, are awesome.
And the lines are long
and people love the food,
so we're going to have more of them.
And so what I'm getting at is
this is a great place to work,
if you're a scientist and
want to come work at the FDA, USAjobs.
But now this this is fun.
And it's interesting
when you're at what you were saying,
nobody does really come up.
We spend a lot of time on baby
formula, for example.
Nobody will ever come up and say thank you
for not having a baby
formula shortage during your term.
Right.
And these are things that like,
we spend a lot of time on pandemic
preparedness with bird flu.
And you know, if nothing happens, that's
a good thing for the workforce unnoticed.
Yeah. And that's okay.
That's part of the job.
Yeah it is, but it's rewarding work.
And, 
we're so glad that you're here, Marty.
We really...
Thank you so much, Sara. Great.
Thank you for your leadership,
both of you.
It's really an honor to work with you
both and we’ll end here.
Great. All right, guys, thank you.
You just saw it.
This just happened.
So thanks so much. We'll do it again.