FDA Direct, Ep. 9 – Faster Reviews, Food Dye Wins and Protecting American DNA

Okay. We're doing this.
Welcome back.
And here I am with, van.
I am going to see you guys.
Good to be back. Lot going on?
We've been busy.
A lot been going.
I haven't really seen the two of you.
We've all been in different places.
Yeah, I had, but the bio conference
yesterday or the day before,
we've been to Stanford, San Diego, Boston.
We've been doing our CEO listening tour.
We've now done four places,
including the FDA.
And we have heard a ton of things.
So many, I think consistent themes
across all the things.
But also at every single forum
we go to, we hear new ideas, new ways
we could do a better job.
And it's been a really productive
listening experience.
Yeah, it's amazing when you get the CEOs
and leaders of these companies
drug developers,
inventors, the scientists in the room,
and you say this is a safe space.
Tell us your ideas for an FDA
that works better for you.
It's amazing.
They will talk,
they will unload, they will share.
And so they did.
And you know, we took a little heat
and I knew this was going to happen
because we did it
as a closed door meeting.
I mean, we might have had to people
depending on the city in the room.
For it being closed door, we took,
you know, and people
we all believe in radical transparency.
But if you want someone
to be honest and genuine
and sharing their ideas,
you have to create a safe space for them.
And since we were not answering questions,
we were not giving talks.
We're not sharing
new information from the FDA.
We were listening.
It was amazing how many people told us
when they don't have to worry
about their shareholders
and their employees and investors
and everybody else, how
they just felt comfortable giving ideas.
And I they gave us a lot of ideas,
and now we could be transparent
in what we're thinking
and what we're going to do in FDA.
But it's really not our role
to force, companies
for telling their deepest,
darkest secrets to the whole world.
And in fact, by doing it behind closed
doors and again, we're just listening to
what they're saying and writing notes
and kind of saying back to them
what we hear them saying.
We learned a lot.
And they talked about sort of frustrations
they may face in all directions from,
you know, how they get their funding,
the challenges they face
with running their operation, and how FDA
has made things easier and harder.
And that's the other thing
we all got a lot of praise to.
You know, one person, spoke about how
the FDA is also doing a good job.
Let's not forget,
but there are ways we could do better.
Thanks for throwing that in. Yeah.
I think it's to the listening point,
though.
I think it's worth sharing the
the format in which you did it. Right.
You guys were truly listening
because each attendee
had what it was about two minutes
and they were on the clock
and they could just openly share
what they were listening to.
My voice was shocked.
I think you're still recovering.
Yeah. He's had a rough voice
for this last week.
Well, yeah, like a couple of the forums.
Literally every single person took a
microphone and spoke from to minutes.
In the forums that were just so big,
we took a line and just let people go.
But again,
the whole thing was just letting people
talk about the frustrations they face.
And of course, you know, there's
certain themes that come across it
that we are happy to talk about.
Yeah, I had some FOMO
because I didn't get to join last few.
So were there a couple of highlights
of new themes you were hearing?
It's like a third of the, feedback
was a common theme in all the sessions,
and I'd say two thirds was unique and,
you know, very different.
And they were very specific ideas
that were formative for us.
These are things we can implement and
act on or, you know, run by our own staff.
So, for example,
we were just talking about the value
of creating a safe space
for someone to share their ideas.
That's how we're doing it here.
We will meet with physicians, scientists,
reviewers, court staff at the agency,
and we ask them, you know, what ideas
do you have?
How could things be done bigger?
Has there been something you've
wanted to do but not been able to do?
If you have their bosses
or their next three bosses right
next to them, then it's a very different
amount of feedback, right?
Then it's, all of a sudden
everything's great.
And thanks to the leadership of my boss.
Right.
But if you create a safe space,
there's good ideas.
And we got a lot of those good ideas.
So I took some of the ideas I heard,
and I went to my team at Ciba today.
And just with some reviewers,
I tossed them out there.
So I've heard this, I've heard that.
What do you think about it?
And oftentimes
they say, yeah, there's a point there.
I agree with this part of it.
This is the part
I might push back a little bit.
This is the nuance that I would add.
And so again it's a it's a two way thing.
We want both the staff here
to feel listened to and heard,
which we're working on.
I'm doing individual meetings
with reviewers now.
You know, it's
great working my way through.
And also I think the companies
and I do think they're places
where they both completely agree.
And those are the things
that we just have to match up
and the place where they disagree.
I think we'd have to, you know, see
which way we should move on those points.
So earlier this week, then,
you made an announcement, Commissioner,
that I think really, addresses
some of that feedback you've heard around
this, priority voucher program.
You want to share a little bit about that?
Yeah. So we're trying something new.
We're trying,
something called the National Priority
Review Voucher Program,
and it's going to be,
a decoupling of the application
so that the lion's share of
the application can be submitted
before that final NDA blr application.
And we could tailor this to other aspects
of FDA, applications that we receive.
But in this pilot program, we're going
to see if we can get that review time down
from a standard to months, down
to eight weeks or a couple months.
And the goal is to create an exercise
where we review
all the wasted time in the process.
We're not cutting any corners
in the scientific review.
It's the same scientific review.
But it never made sense to me
that companies would sit around waiting
for their clinical trials to finish.
And there's all that idle time
and it's not being utilized.
And when they submit
the final application,
you're looking at manufacturing data
that really had nothing
to do with the final outcome
of the clinical trial.
So by getting most of it in
and then once the clinical trial is done,
those end points are submitted
in sequence.
Initially, the top line results
so that the reviewers can hone in
on where they're going.
And then the actual last, you know,
component of the application
without signatures and little steps.
And by just cutting all the wasted steps,
we think there's a tremendous opportunity
to get that down significantly.
If we can reduce some of the R&D costs
and animal
testing, as we've announced,
and our plan to reduce animal testing,
cut down
that six months of animal testing,
where applicable, as the organ on chip
technology improves
and where the computational modeling
gets better and better
at predicting toxicity,
better than the animal testing.
And then on,
you know, throughout the
throughout the entire process,
we have enhanced communication with this,
pilot program.
This is something that was a common theme
on the listening tour, a minute call
sort of quickly
could save them months of guesswork.
And so mind reading is a bad thing
in any setting in the world.
I think it's worth just for those who may
be less familiar with the process today.
Right. Without this voucher program.
So what you're saying is typically
what happens now if the manufacturer
has a question of a comment
they got from a reviewer
I heard in one of the forums,
it was like up to days
sometimes to get a quick answer.
So you're saying now we can have more
real time feedback for a minute call,
so you're not waiting days.
So that's just like that's just the tip
of the iceberg of the commissioner's plan.
But of course, yeah, there's a tiered
system and manufacturers a different time.
There is a clarification process
that exists now, but having a more open
dialog, quicker conversations
that can speed up a lot of this process.
But the current process,
once we get the completed application,
can still take, you know, up to a year
to make a decision on a product.
Yes or no.
And the commissioner,
I think, is talking about a program
where we get that down to two months now.
Time, of course, is money,
but time is also patient lives.
I mean, shaving that
amount of time is live potentially saved
from beneficial products, entering faster
people with less disability
who are living and functioning better.
So there's this huge
patient need to do it.
I've heard a lot of it.
And there's also the financial part,
which is that every month
the companies wait, they are losing money.
And that also means their investments
in making new products is diminished.
So this solves two of these problems.
I've heard a lot of praise
from the industry,
especially people who are long
time said you got to get this time faster,
including very esteemed CEOs
of really major corporations.
But I've also seen some criticism
from some of the people in the past
who were the biggest proponents of FDA
cutting down the bureaucracy.
And their criticism is,
you know, who are you to decide
who gets to have these lottery tickets?
And the answer is, you know,
my first answer is,
why don't you see how it goes and then see
if you disagree with the picks?
Let the picks come and then tell us if you
don't think those are the most impactful
sort of things that are really in
the best interest of the American people,
large, large, unmet public health
needs where you can have a huge impact.
National priorities such
as the domestication of manufacturing,
moving, manufacturing on shoring it,
that's a national security issue.
And, pandemic preparedness,
for example,
we have to have a good system set up.
You know, during the first year
of the pandemic, they stood up basically,
a special system
to review the Covid application.
And they did it in a relatively short
period of time without even doing
some of these novel techniques
of decoupling the application,
moving ahead, the CMC portion.
So, so we know it's possible.
The question is the resources involved
where the wasted time is.
And we'll have a committee to decide
who gets the initial round of vouchers.
I wish I wish we could do it agency wide,
but the way you learn is that you have to
do things in iterations
and start with a small pilot.
And once we figure this out,
then we can build on those learnings.
But we can't keep doing the same thing.
You have to try new things.
You have to be an innovative organization.
That's one of the longtime
criticisms of government.
We're going to try something new.
As you say, a committee is going to be
in charge of picking this.
I'll have three votes. Right, Marty?
That's kind,
but it's going to
be a committee of diverse experts
sort of thinking about these priorities.
And ultimately, I think that the critics
should let let things
let let it happen
and then see what you think,
see what the pics are,
and see if you think that
those aren't really useful things
for the American people.
And I think it's worth noting for people
who are less familiar with this,
that there is some precedent for this,
as you mentioned during the pandemic.
But the agency has a history
of some of these kind of voucher programs.
And this is a little bit different, right?
It's focused on national priorities.
They're not transferable. Right.
So there are some nuances here.
But it's not like this is you know,
we have some practice with us.
As we were talking with the team today
about a, a drug that really offers
tremendous benefits, almost like benefits.
I don't want to use a particular word
which might even give away
what the drug is.
That's why I checked myself, a drug
that really offers tremendous benefits
to patients
in neglected domains of their life.
Okay.
And then we asked this team
if you really had this application
on your desk tomorrow and you and you
and they fully understand
the gravity of the situation,
how fast can you turn it around?
And they said, you know,
a month or two months is quite reasonable
for us to do it.
And so not only is there's a precedent,
there's a well, I think the people here
who believe in transformational products
believe it can be done.
And so I think it's it's a pilot
and let's see what we do.
And I think one of those components
you've talked about, Marty, is around
the tumor board style
kind of decision making.
What is that?
Well,
it's, it's interesting because when I've,
had questions about certain products
here at the FDA that FDA staff
will often to do, often
offer to do a briefing.
And what they'll do is they'll come
and present the data, present the trial
results, and, that way I'm informed.
So after they make a decision,
if I'm asked about it, I'm in the loop.
And, you know, I ought to.
I say like, do what you think is best
in your best scientific judgment.
But it's been very informative
to get these briefings.
And the briefings are so good.
The data is consolidated and presented
in such a concise way that I thought,
this is a little bit like tumor board,
where we have these very complex patients
with very complicated histories
and on many different trials
and medications and so forth,
and they're presented in a very concise
way where a multidisciplinary
group of experts can weigh in.
And after that very clean presentation,
we all go around and render our ideas
and sometimes
what we'll officially do a vote.
And so it
it does seem like a tumor board style
meeting to at least review
the clinical trial results.
And that's what editorial boards do.
That's what the New England
Journal Jama editorial boards are doing.
That's what we do at Tumor Board.
We're making these team based decisions,
and sometimes it's good to have somebody
who's a little bit of a fresh eye,
you know, somebody who is, you know,
a radiation oncologist or an oncologist
weighing in on the surgical approach.
Sometimes it's helpful
to have that, the fresh eye.
So the
I think I completely agree with that.
And another key
aspect of a tumor board style discussion.
So what Marty means is like
what is a tumor board?
A tumor board is you're presenting
a patient that's complex, perplexing.
You don't know what to do.
And you're hearing
from a surgical oncologist,
a radiation oncologist,
a medical oncologist, sometimes
even the patient's general internist,
sometimes the infectious disease doctor,
sometimes the consulting rheumatology
service or endocrinology service.
If they're managing
a particular complication,
you're hearing from diverse doctors
and you're
trying to get a better understanding.
And I think one of the points here is that
the FDA has maybe too often
thought of that
only the dengue virus researcher
can contribute to a dengue virus vaccine
development program.
Only be I'm an oncologist by training,
but also a general internal medicine
doctor by training.
Only the oncologist can only think about,
AML and it can only think about myeloma.
But sometimes when you're in the room
and there's an infectious disease doctor
who doesn't know a lot about myeloma,
but they may ask a very astute question
about the trial design,
because they're remembering something
from an infectious disease trial
that didn't seem like it was related,
but actually is related in terms
of sequential hierarchical design
or sort of a Bayesian calculation
or some statistical point
from something else.
And so what Marty's talking about
is sometimes people who are curious
and thoughtful can help shape decisions
and help you decide on products.
You can get people
from different disciplines
to kind of weigh
in on really important products, and
I think it can be a much richer
and more beneficial conversation.
Like every board in the world,
brings people from different vantage
points to make decisions and to vote.
Every editorial board,
every, corporate board, every,
setting where you have tumor boards,
they're bringing
in different perspectives.
For example, in editorial boards,
there's always a statistician
or epidemiologist
that is a part of the review.
Now, they may not be familiar
with the details of angioedema,
but they're bringing
in a fresh perspective.
And sometimes that's good for discipline.
They'll say, look,
if we're following the loss of statistics,
this is in bounds or out of bounds.
And so I think that's
a healthy perspective.
You know, I wish we I wish we could just
do this on a broad scale.
But we have to get it right.
So that's why it's going to be a pilot.
And we have to be cognizant of the fact
that,
we have a limited resource and that is
the number of scientific reviewers.
Now, no scientific reviewer was laid off
with the reduction in force,
but there is normally a turnover.
And, we we're hiring scientists
and doctors.
I'm hiring vigorously hiring managers.
I just saw the new job postings go up.
Oh, by the way,
if you're watching right now and you're
a medical review or a scientific reviewer,
look@usa.gov
job postings and and consider applying.
It's a great place
to work. It's a great place to work.
It's exciting.
I think we're
gonna learn a lot from the pilot
and then we'll go from there.
And so I think the question
now is timeline.
And so I know the team is working
really hard to get all the application
kind of details together, and we'll be
sharing that in the next couple of weeks.
That's right.
And you can get three votes
on the committee. So I
to fly that the good
everyone is going to have three votes.
But ever get the
you know you won't get your three votes.
You know the other thing
I'd say about the pilot program
is that one of the big barriers
in any big institution in government
is to show people what's possible.
And you don't have to show
that many times before
you kind of open a door in someone's mind,
because we all get trapped into thinking,
particularly
those of us who work in hospitals,
that what's possible, what's not possible.
Somebody comes along
in medicine once in a while
and they do something different,
and then suddenly
that doors open in your mind.
And what's possible is now
and let's let's be very honest.
Can I be very honest, please?
All right. I'm going to be very honest.
We have been getting clocked
by other countries that have created
an accelerated pathway for preclinical
AI and in phase one.
And so and that's new.
That's in the last couple of years.
And so unless we can innovate
and be competitive, then,
falling back to sort of
protectionist strategies
is not really a great, great path forward.
So we've got to try new things. So,
I just wanted to point out we have a very
competitive international landscape.
And we have support to the.
I just met with the head
of the European Medicines Agency
and McCook and with, Lawrence Talon,
head of the UK
version of the FDA
for drugs and medications and devices.
And, they're looking at Australia
and China
and they're saying, hey, wait a minute.
If we don't figure this out,
if we don't figure out how to use big data
in a way to create synthetic controls,
if we don't figure out
how to streamline these IRB decentralized
amalgams that companies have to deal with,
which is, you know,
I think you and I have been fighting IRBs
our entire life.
I've been avoiding them.
I do better research for a reason to skip
the IRB because it's largely exempt.
Right? But you're absolutely right.
If other countries are getting ahead of
us, we have to ask ourselves one question
are they doing it
through negligent shortcuts,
or are they getting ahead of us
by cutting unnecessary bureaucracy?
And in some cases, it's
a little bit of both, to be honest.
We're not going to follow them
in negligent shortcuts.
But when it comes to cutting unnecessary
bureaucracy,
we have to follow some other countries.
There are some countries that have taken
the lead, particularly in the phase
one space, and that's just not
the United States cannot retain
the dominant biomedical position.
If literally all of the phase ones
in the world are done abroad,
that's not a tenable position.
We have to bring that back.
And that means in some cases,
we have to think even beyond the FDA,
how HHS and CMS can help us in this quest.
You know, it's such a delicious point.
It just makes me
want to have a Kraft Heinz.
Kraft. Oh, I don't care. Right?
Right.
Or a General Mills product, or maybe
a Danone yogurt or something like that.
I just feel a craving for it right now.
So you're referring to the recent news
from those organizations
saying that they're committing
to removing, our petroleum based food dyes
from their products,
which is really exciting.
No way.
They did what they did what?
You know, you and I think Kraft went
further, it's not just petroleum based.
It's all artificial.
Artificial dyes. Yeah.
So thank you to Kraft Heinz.
Thank you to General Mills
and, the pledge to get it out of there.
Food is a pretty aggressive timeline,
which is exactly what we wanted.
So I, I had missed this.
And reading this, I had missed this
like a couple of weeks ago.
I think also Sam's Club said
they're going to do something
similar around their products as well.
So it's great
to see a lot of these companies
starting to and work towards their goal
here.
Yeah, a bunch
more companies too out there.
Probably too many to mention.
Dunkin Donuts actually has done it.
Except for, I think, the sprinkles,
which go on there.
Yeah. Somewhere
I saw something on social media.
There was a brand.
I don't know if I can name them.
That's that's starting to say
welcome to the club. Right.
It's like, oh, we've been doing this,
you know, for years.
And so it's nice to see other companies
and organizations follow suit.
So it's fun to see this kind of consumer
movement.
And, you know, while
you guys were at one of the CEO forums,
I was with the consumer brand
Association, which represents
a lot of these big companies.
And, you know,
we had a great discussion. Great.
They've been really great.
And they're really excited to kind of work
with us and support a lot of these broader
objectives.
And, you know, they're all on board
and they're trying to figure out
how to do this.
And, I have to say, Marty,
they extended a compliment to you
because they said that they've never seen
this level of engagement from the FDA.
So back to and from the committee
at the commissioner level.
And so to bring the EFF back in the FDA,
I think they're all really seeing that
for food, not federal.
All credit goes to Kyle Diamantes.
I just talked to him this morning,
and it's really a great day.
Touch base
with Kyle on this incredible enthusiasm
for removing artificial food dyes.
We had a great talk
with Rick Pastor about of fact,
we should have just told him
to come over here with us.
We should have had him join us. You know,
there's a lot.
There's just a lot going on in cancer
right now.
And it's exciting.
And he's done a lot of exciting things
around rare disease.
And we talked to him about some of that.
What's that book
that Kyle was telling you about,
where it tells you what a breaded shrimp
is. And it's like 
Oh, standards of identity
and some identity. Yes.
Have you finished
reading all the volumes yet?
Marty, to get prepared for this,
I'm on page 
I'm I'm at mayonnaise.
What makes mayonnaise interesting?
Yeah, yeah. I'm curious.
I haven't followed that too closely, but
I'm curious what they do in that space.
Yeah.
Speaking of cancer,
care, we learned something
a little concerning,
this week at the FDA,
and it involves China, and so it's,
it's not their fault
they're doing this, but we learned that
Americans have had, therapy whereby
and the FDA in the last administration
and, okayed this.
But Americans have their I can have
their cells removed for cancer treatment
sent to China, where they are genetically
engineered, that is genetically edited,
sent back to the United States, where it's
then infused back into an American.
And so, from a pure national security
standpoint, it sounds very concerning.
And the name of the patient
and personal health information
can be attached
to the sending of the cells,
which I think is a tremendous
vulnerability.
And you right,
the administration turned a blind
eye to this,
and it just came to our attention.
And I think what people don't recognize
is, of course,
increasingly cells are recognized
for being able to be engineered
into being potent killers of targets
that are preferentially found on cancer.
But of course, the worry is cells
can be engineered to be
potent killers of targets
that can be found anywhere.
And so one of the vulnerabilities,
I think, from allowing American cells
to be sent to other countries
with patient health information
and names attached
to hostile countries,
is, of course, the risk of what happens
to those products abroad.
And they may not always
be adequately tested,
they may not be ways to test them,
although fully on the way back in.
And so this is a big concern.
Yeah.
I mean, you think about the possibilities
and it's it's a little frightening.
So we love Car-T therapy.
We love cell therapy and gene therapy.
But we'd like to see that work done
in the United States or among our sort of,
friendly countries, if countries
friendly to the United States.
Yeah. So,
I guess we'll take a look at that.
But, that was something,
and it's interesting what you learn.
Yeah.
And I can't talk about everything,
but just in cyber, I will tell you
that, you know, safety,
something very important to the FDA.
And, of course, there's national security,
safety, their safety,
privacy, their safety of Americans
information, their safety of drug products
and just in the course of the six weeks
I've been on the job here,
a number of really important safety
concerns have been brought to my attention
for different drug products in cyber,
which governs a huge class of things,
from vaccines
to gene therapy to biologics.
And in every single case, we can assure
the American people
we take it extremely seriously.
We leverage the power of big data
to quantify safety signals.
This is something
I think people don't fully understand.
Safety signals will never be adequately
and fully
captured based on prospective
randomized controlled trials.
That's not possible.
That's always been
my position, has always be my position.
Some safety signals can only be collected
in large observational data
sets that are, well,
very carefully matched.
We have a number of these safety signals.
The response is different
depending on how good the product is.
The response may be to warn people
about it, to tolerate it,
to give another medicine,
to try to mitigate it.
But in cases where it
the benefit of the product is more dubious
or uncertain,
the response may have to be stronger
or more swift.
And in cases of personal health
information, Americans identity
in cases of national security.
I mean,
I think we have to be extremely strict
and really protect
American interests here.
So I saw you put something out.
You basically said that,
we're not going to approve
any more of these gene
therapies of American patients.
That is, their cells, in China.
Moving forward, from this point forward,
that is we're not going
to, disrupt the treatment
that Americans might be getting.
And you want to increase
the amount of informed consent.
People should know there's
they're living cells in the United States,
are being sent to China for gene editing.
And then going to be infused back to them
if that's going to happen.
They should certainly now
with proper informed consent.
I wonder if patients actually
how aware they are that that's happening.
Well,
I mean, that's a really great question,
which is that what is informed consent
and what does it really mean?
I mean, having done it on the doctor
side, having witnessed it on the side of,
you know, as a fellow being in the room
for a lot of, protocol
concerns as well as for having done
protocol consents over the years,
I can say that it's a big
it's a big thing, which is that,
these consent forms can be very long,
and people may not always read
all the fine print
and what consent often means is
what are the things
the doctor or the counseling provider,
brings to the patient and patient's
family's attention
in that brief window of time
you have them,
which is usually the most salient,
the most interesting,
most important concerns.
But I do think that people do have a right
to know where
their cells are being sent and manipulated
when they're coming back to them.
I do think it's super important
not to disrupt
people who are in the process of that,
who are expectantly waiting for products
to be returned to them.
I think we got to strike the right balance
in how to tackle this,
but I think people of minimum need to know
what's going on
with their biological products
and their genes, and then they're
living literally living tissue
that can grow.
And then we also need
to take into account safeguards.
So what I'm hearing you say is
we don't want to create hysteria.
But chances are,
most likely there's nothing
nefarious going on with the gene
editing of the cells of Americans
in China being infused back to America
and back to these, American patients.
But proper, informed consent is critical.
And moving forward, you get sounds like
you're going to take some steps
to look into this and to make sure
informed consent is accurate.
Absolutely. Great.
Wow. I learned a lot.
I mean, as a non clinician,
I don't even know that
that was something
that could happen in a therapy. So
this beauty maybe Bigfoot
can get us closer to the glass
of our beautiful campus next time because
we've got like two levels of glass here.
So some in the background maybe
muted a bit, but it's a gorgeous day.
You've got high standards, Marty.
I have to say, I saw the NIH just started
their own podcast and I have to brag.
I think our background
is a little much better than theirs.
Our campus
is certainly much more beautiful.
Well, I love Jay.
You know, Jay is a friend of ours.
But, yeah, I saw that.
I think we got better production quality.
And, but it's a friendly rivalry.
I love Jay, our campus is more beautiful,
and we have farmer's market
every week, and,
it's an amazing group of physicians and
scientists here that I've gotten to know.
And we're going to keep getting to know
them.
And we're hiring.
We're hiring hired. We are,
we're always hiring.
The FDA has always been hiring scientists
and should always be hiring scientists
and inspectors in the future.
We should always have jobs posted.
You know, let me give one more plug there.
I've been talking
to a lot of the individual reviewers,
like in back to back meetings
for the last few days.
And one of the things that comes out to me
is I ask people like,
what did you do
before you worked at the FDA?
And, some people were like,
I was a allergy immunologist
in downtown Washington, DC doing largely
private practice.
Somebody was like, I was a pediatric
cardiac intensivist in Arizona
doing private practice.
And the reason I say that
is that this is somebody
who before they came to the FDA,
they had a lot
they hadn't had a lot of experience
in regulatory science.
They might not have known
what a safety label change
was or what section
of the drug label was,
because that's not the sort of things
you think about as a doctor.
But they came here open minded
and they learned
all that stuff on the job,
and now they know abbreviations and words.
I don't know, you know.
And so our point is that if you're
listening and you're a clinician,
a scientist or researcher,
and you think to yourself, hey,
I don't know if I know enough about FDA
and drug regulation to do this job.
We will train you on the job.
I mean, that's not a barrier
to coming to work here.
The real question is, are you interested?
Are you curious?
And if you're curious, you can
learn things to your heart's content.
Are you intellectually curious?
And do you hate billing and coding?
There's no balance.
Coding.
You're not on the track docs.
Yeah, nobody's looking the same.
You only saw patients today.
Let's try to get that up.
But I'll say one more thing.
There's some people here
who still maintain
a half day clinic in somewhere else.
So I've met people here
who are still on Tuesdays,
going to GW or going to Hopkins
and running a half day clinic.
So if you still want to practice
a little bit, that's also permissible.
We welcome those arrangements
and a lot of people like that.
And even when I was heavy
in the research years, I kept a hand
in the clinical piece
in the operating room.
And it has tremendous value
to a lot of people.
For me, at this point, I was thinking all
I was thinking about running, you know,
I ran clinic for the ten years
I was attending and up until like two days
before I came here
and I was thinking about what it would
take to kind of continue to run a clinic.
But then I realized in this job, it's
actually
my particular job will be very difficult.
You got a huge shout out of Sieber.
You're also the chief medical
and scientific officer for the entire FDA.
So we're using all of your talents
in so many different ways.
Thanks for that.
So he's very intellectually curious.
Is he is always learning from him. Thanks.
But we have a lot of amazing people
that want to come to the FDA at all
levels, scientific reviewers, managers
and top leadership.
So it's kind of cool
to see all this incredible talent.
And one more thing
I think reviewers should know here
and elsewhere that we have your back to.
I was telling every reviewer is like,
I support you pursuing the truth
about the application.
We will always be flat.
We will be flexible,
we will think about ways to be faster
and more efficient
and more flexible, and make products
available to people with rare disease.
We will also always retain the curiosity
of pursuing the truth, whatever
that truth is, of the application,
and I will support them in that.
You know, every time there's been a, a
bit of a disaster with a product decision
at the FDA when you go back and,
you know, look, and this is
there's nothing in recent time
that I can think of in our weeks here.
But if you look historically,
a whole bunch of
people, scientists at the FDA
have have said, no, don't do this.
They saw it coming,
and one person reads it through
and when you look at some of these
big public health problems
that have started from a decision,
that's usually
sort of the forensic analysis
of the organization or the decision
making or the personnel and the
and the flip has been true in FDA history.
In the s, it was a single reviewer
who single handedly kept the lid
on right off the market for,
you know, nausea.
And that led to the amendments, Kieffer
Harris, members that gave the FDA
the efficacy authority.
So, you know,
just as one person can not heed
the advice of other people, one
person can often be an important person.
Regulatory history.
And you're right, a lot of these things,
you look back and you see,
the die was already cast a long time ago.
For what it's worth,
I just have to say, listening to you
and just reflecting on conversations
I have across the agency,
you mentioned people don't,
you know, talk front of their boss. Right?
So sometimes you'll ask people questions
and you'll even
catch up with them afterwards.
People ask me what it's like
working with the two of you,
and I say, it's, you guys are big nerds.
You're also right.
And I mean truly, like,
I watch and you're talking to scientists
and you're asking them questions
about their research.
And a lot of them,
like, I'm not used to the commissioner
asking me questions on my research.
And I think that's the kind of place
that this is where you're facilitating
that dialog and discourse to really nerd
out on the science and the data.
And that's pretty cool to watch.
Well,
our job is to support the people here.
And so to do that,
we have to understand them
and we have to roll up our sleeves.
We have to be present.
We can't be insular in our sort of cozy
central office here.
We got to be out there.
And you know, when I think about doctor,
the relationship between doctors
and hospital administrators, there's two
general types of relationships out there.
One is where the administration
is completely out of touch
with the day to day work, and the doctors
have a tremendous amount of bitterness
and things don't work
as well on the ground as a result.
And the other arrangement is
where the administration is on the ground.
They circulate, they talk,
they know the people, and they ask them,
what do you need to do your job better?
What can I do?
What what could function better
to make your job, work better?
And so, that sort of
in touch connected relationship,
I think, is a recipe for success
in any large organization, be it
a government or non-government.
Absolutely. Yeah, I completely agree.
As a doctor working there,
you're always most frustrated
by the people running the hospital
who didn't always like to be a doctor.
And similarly to me, the most validating
thing is if you tell a reviewer,
ask him a question,
and they say, actually, you know what?
That's a good question.
And actually, yesterday
we asked the company
to give us the answer to that question.
So it's like,
okay, good. Yeah, we're on the same page.
We kind of get the science
in the same way.
And maybe I'm a I'm obsessed
with our wonderful cafeteria here.
And I eat there all the time
because people in the hospital
used to say, have you ever seen a senior
executive eat in our cafeteria?
And in the end, the answer was no.
Maybe one.
But you never saw them, so, you know,
they were out of touch with how horrible
the food was.
You know? So it's just good
to be out there and circulate.
You really do eat there, like,
almost every day.
Yeah. Quickly though.
Yeah. Know quickly between meetings, it
good to see you guys.
Yeah. Good to see you.
Should we do it again? Yeah, absolutely.
Should this be the last episode
in our history?
Oh, gosh.
We can let the people put in the comments
what they think.
But I got a lot of a lot of people
at the SEO forums
watch these videos
and they find it interesting.
A lot of people here,
they watch these videos actually.
We've been getting a lot of good feedback,
even when I was out with, you know, KBA,
they said, can you tell us
about the podcast and all of that?
So people are watching
and they're they're sharing comments
and people ask me how frequently and,
you know, when does it come out?
You know what?
Whenever we get minutes to go,
just have this conversation.
We sort of say, hey, let's walk over
there, let's grab Bigfoot and the team.
And, Tim, thanks for being here.
And so we just come over here and do it.
Probably doesn't like it.
Yeah, very spontaneous, but here we are.
Your name is now known to tens of people
worldwide, tens of people watching.
My mother watching on a loop.
Yeah, yeah,
five of them are me watching. Yeah.
Right. Yeah.
All right. Good to see you guys.
We'll do it again. Thanks so much.