FDA Direct - Special Edition of FDA Direct

Okay. Thank you, everybody for being here.

What I thought we would do

is talk about the last year
and what we're where we're going next.

This coming year, we have some challenges.

When we started with the restructuring
and consolidation.

That was a tough time.

We came out of that strong and had some
impressive performance metrics.

We had to do some work to ensure
that people

have all the resources
they need to do their job well.

And so today we're going to go over
the performance metrics of,

really the last months
I've been here now months.

As of this week.

And so I want to talk about where
we've come

and where we're going.

By the way,
this is the new call that Barclay Butler.

Doctor. Butler.

Where are you? Doctor Butler.

Good job with this seal.
This is impressive.

This is the first time we've had a seal
for the FDA, and, it's very impressive.

So I'm looking forward
to wearing this pin.

We've got a flag with the seal,
and it's just,

I think, an incredible moment
to have some pride in this institution.

In my opinion, one of the greatest brands
in the world is the United States FDA.

And that's
thanks to all of your good work.

So it's an exciting time.

Now our mission is very clear.

More cures and meaningful treatments
for the American public.

We want to see lower drug prices
and an America first unapologetic agenda

when it comes to bringing manufacturing
back to the United States.

It's a national security issue,
and we want healthier food for children.

This has been a huge priority
in this administration.

And so these are very clearly demarcated.

Our primary goals,
we've got many more goals.

As you know, the FDA regulates
% of the US economy.

It's everything from cosmetics to dog
food to mangos coming across the border

to microwave ovens to devices
and wearables and of course, drugs,

which is what many people think of
when they think of the FDA.

So our goal is to achieve this
mission is to disrupt the to year

time frame that it takes a new drug
to come to market.

I learned about GLP one drugs when I was
in medical school about years ago.

Why did it take that long?

It's a known peptide that's in the body.

And so,
we need to challenge this assumption

that there is something promising,
for example, for breast cancer.

But we just have to wait or years,

even though the results
look pretty impressive in early studies.

So we need to do this while,

holding
to our mission to safeguard the public.

We don't want a public health fiasco
because a quarter was cut on safety.

And so safety has been the number one
goal of the FDA.

And it will continue
to be the number one goal.

We want to modernize the agency.

And while keeping safety number one,
we want to see things

move more efficiently.
That means faster approvals.

And we want to use gold standard science.

I've stood by the scientists
here at the agency.

Every decision on a drug,

every approve or reject decision on a drug

has been the approve or reject decision
of that primary review team.

So I'm going to I've honored that,

the scientists here and I think
we need to stand by our scientists.

And so that's, that's what I plan to do.

Now, where are we on drug approvals?

We had a near record last year
with approvals of new drugs.

That is above the five, ten, 
and year average.

So we had a banner year
for new drug approvals.

We also approved drugs at a
in a shorter time

frame than in a long time,
including hitting some new records.

You may, have heard for those of you
not directly involved

in the Sanger to nab approval,
that is a powerful medication

for a Her
mutated non-small cell lung cancer.

days from filing.

That's a record.

Tech Dara,
that was just a couple of weeks ago.

days from filing.

I mean, these drugs are so powerful,
they can bring people out of hospice

and give them hope again.

So when we see these
these impressive results,

in the case of Tech Dara doubling overall

survival.

Three the,

improvement in disease
free progression or death,

for multiple myeloma in the case of HEB.

We went from a standard of care response

rate of tumors of to %,

now to % reported in this trial.

So when you see something amazing,
we want to act with the same urgency

that a patient would want when they see
something promising that could help them.

So the new priority voucher program
has had an average decision

time of about days,
from about five products

so far
that have gone through this pilot program.

Of course, most drugs
are not going through this pilot program.

This is a pilot program to see if we can
do things differently, more efficiently.

And so I think the teams
here, the, scientific teams,

which are the groups that nominate

the drug products for this new pilot
program, they've done a terrific job.

They've demonstrated that we can do this.

Overall, last year
we had an average approval time

that was significantly below
our four year average.

That was about days.

Again, safety is the number one priority.

But if we can reduce idle time,

we can deliver some innovation
when it comes to regulation.

Now we have, powerful AI tool called Elsa
that was homegrown.

Thanks to Jeremy Walsh and the team.

And you see, this is an optional tool.

As many of you know, it's voluntary.

No one, is required to use it.

But by interacting with this

AI tool, asking questions, having it

retrieve parts of these gnarly 
plus page applications,

the reviewers
find tremendous value for this, tool.

And so what you see is, though,
even though it's optional,

plus percent of our staff

at Cedar, for example,
have used it last month,

and that we track the number of daily
unique users.

And it is almost everybody.

It is almost everybody.

So we're going to continue to

innovate in this space.

We were the first government agency to
have an AI tool agency wide for our staff.

We were the first government agency
to have an a genetic

AI tool for all of the staff, agency wide.

And so we're going to continue

to have more features, more buttons
that are unique to the FDA workflow.

So it can, for example, confirm
that the formatting is correct for tables

or confirm
that the application is complete.

We have a day filing period.

We've been able to get
that done in minutes with the AI tool

that's reviewing
the completion of the application

has nothing to do
with the scientific review.

It's just checking to see
if the application is complete.

With technology today, it should not take
an additional two months

per drug just to make sure
the application is complete.

If you're a patient waiting for something
that's potentially promising

to, waiting two months to do
something has its own risks.

That is, patients not being able
to have access to something promising.

Now, in terms of meeting
our user fee, target dates,

we are at a historic high at %.

We need a

We need % of decisions
to meet their target dates.

And in order to trigger the PDUFA 
for funding, we were at %.

We're now at %.

And so I want to thank everybody
who's worked hard

to, ensure that we meet all of our PDUFA
target dates.

Again, safety is the number one concern.

But a lot of times this is organization.

I've told the scientific team to
if you want to convene an advisory

committee, think about that early
before you get close to the user fee date.

We don't want to miss user fee dates
because we didn't preplan

for an advisory committee.

Of course, advisory committees
take time to set up.

So I think they've done a great job
doing that.

Of course, it is entirely their decision
to convene an advisory committee

if they find it helpful.

But pre-planning is a healthy conversation
that I've seen now.

Another
major goal is lowering drug prices.

And that's through a couple mechanisms.

Number one is more generic drugs.

And so we're building
on one of the successes of Doctor Gottlieb

in his tenure, when increasing the number
of generic drugs was a priority.

And so you saw last year
we shot up to new generic drugs.

I'd like to see more generic drugs and
more generic drugs in the United States.

And I hope we can see a GDUFA

fee negotiation that creates

the incentives that we need to encourage
manufacturing in the United States.

Now, the other

major area of drug spending is something
called biologics, a class of drugs.

Many of you are very close to this.

Many, many of you are reviewing drugs
in this category.

The biologics together

account for % of drug spending,

even though they're only about %
of prescriptions.

Now, why are they so expensive?

Because they come from cell lines
and they cost a lot of money

in the development.

R&D costs may be higher.

Well,

they shouldn't be unaffordable

because then people
just don't have access to them.

So you can have a cure for a disease
that is % effective,

but only if only half of the population
can access that cure.

That is, can afford the cure, then that

drug has an advocacy
now on a population level of %.

So we have to
make sure medications are affordable.

The generic versions of these expensive
biologics are called biosimilars.

And so we have eliminated
the comparative efficacy study.

That is an entire new clinical trial
that was stood up

just to show
that a generic version of a biologic

could be used, okay,
that that it could go through the process

that was $million,
depending on the drug.

I've heard folks who are in this space
tell me that this announcement alone

cut their research and development costs
in half,

say, from million to million.

I've had
people tell me it's going to shave off

to years, because if you don't
have to go through the comparative

effectiveness study, we don't, by the way,
require it with small molecules.

Why were we doing it
with generic versions of biologics?

We need to do everything possible
to increase

affordability
of this class of medications.

We also did some other reforms.

We eliminated the direct direct PK
comparative study.

And we also eliminated
the routine requirement for a three way

PK comparator study.

Each of those studies
could be $million.

So it it does add up
when you lower the cost of R&D.

It has the promise of translating
into lower drug prices

for my mom and your mom
and everyday Americans that are out there.

We also are supporting interchangeability.

When the patient and the pharmacist
say, hey, we want to use a biosimilar

that is much more affordable
than the expensive biologic.

We want to encourage that.

So we put out a statement on that.

Now on the device side,
we've also had a banner year

with approved last year again.

This is thanks to the incredible
work of everybody. And,

the, Device
and Radiological Health Center,

thanks to the good work of Rochelle Tarver
and others.

So I want to thank that team
for their banner year.

This, speaks

to the work on direct
to consumer advertising.

That is pharma ads.

This is the number of enforcement
letters that have been sent out.

This is not our graph.

This is a graph from,
one of the trade publications.

And the article was titled
A head Spinning Year

How US FDA's AD Enforcement
Blitz Reshaped Drug Promotion.

Now, I've personally noticed
there are fewer ads

and the side effects
are more explicitly stated.

I think we are starting to see
better compliance with the two regulations

that generally have not been enforced.

That is the regulation
that Ads have to have a fair balance

of information for people,

and they

cannot create a misleading impression.

And so, in the last year,
in my first year,

we sent out enforcement
letters, by the way.

The purple number is
the number of specific letters.

Black is untitled letters.

That is sort of generic letters.

So you can see last year
the number of enforcement letters

directed to a specific,

entity was zero.

We sent out zero.

But, in our first year here,
my first year,

we were able to send out enforcement

letters and letters to the industry

notifying them that we very much plan
to enforce our regulations.

We will crack down on inappropriate direct
to consumer pharma ads.

Our job is to safeguard the public,
and if we see things that are misleading,

then I'm kindly asking the industry

to redirect the enormous
spend that they that they,

put on these direct ads and redirect

that money to lower drug prices
for everyday Americans.

Now inspections,
we have a big inspectorate, as you know,

and surprise, inspections
overseas are way up.

We switched to more surprise inspections,

last year.

We want to see inspections that work.

And if an inspection is pre-announced

that if that is,
if it's scheduled, it's a joke.

It's an announced inspection.

It's no inspection in my opinion.

And so we are getting away from scheduled
inspections, which have been,

concentrated overseas

and moved to surprise inspections.

It then makes sense to me
that we put American companies on U.S.

soil through the wringer with surprise
inspections and more inspections.

And manufacturing sites
overseas have announced inspections

and fewer inspections.

So we are rebalancing that dynamic.

Now, on the food side,
we also have had an increase

about a % increase in food inspections.

And as you know, many of the food
inspections are done at the local level.

% of routine produce inspections,
for example, are at a local level.

So we are sending money to the states,
empowering them to do food inspections

that they generally do
at a lower cost point,

and they're more proximate to the farms.

On the

tobacco side, we have
had a significant reduction in the backlog

of these pmta applications.

The applications
sort of poured in at a moment

where there was discussions
of sort of a grandfather grace period,

and so the center was overwhelmed
with applications.

And as you can see, we've gone down
significantly in the backlog,

and we're going to keep going, I think, at
a this pace or faster this coming year.

It's important.

On the food side,
we had this tremendous response

to our call to remove
all petroleum based food dyes.

That is, the nine artificial dyes
from the U.S.

food supply.

We had about % of the industry
that represents

about % of the food say yes.

General Mills,
I'll just cite them out there.

Many companies here that have been
absolutely terrific to work with.

General Mills just achieved their goal
of removing all artificial dyes

ahead of schedule.

So they just hit this a few weeks ago.

We put it out, to, congratulate them.

That's what we want to see.

We want to see companies
do the right thing.

And many times they tell us
they just want a level playing field.

If they can have a level playing field,
they are happy to move

in the direction of consumer demand.

Now we also want to have natural food dyes

that they can use as an alternative
to the artificial dyes.

So we, had a record number

of natural dyes approved last year.

We had, six.

And we're about to approve two more.

So for this month period,
we're on the brink of eight approvals

for art, for natural dyes
to replace the artificial food dyes.

Companies want alternatives,
and they want alternatives

that are cost neutral
and feasible to implement.

And I think seeing a giant company like

General Mills.

Lastly,

when they come and say

we've we're ahead of schedule,
that tells us this is doable.

This is people said it couldn't be done.

It's getting done now.

The culture of the staff,

and the workplace
satisfaction is very important to me here.

There are phenomenal people.

I've been impressed by all of you and,

many of many of you
that I've gotten to know.

It's pretty amazing.

People come here from all backgrounds.

They, sometimes make a personal sacrifice.

They are giving up sometimes
what could be a higher salary outside.

But they do it

because they believe in the mission
and the incredible brand of the FDA.

And so, Melanie Keller,

Doctor Butler, Melissa Shay,
the whole team that has done

an amazing job to try to, create
a positive workplace culture.

It's working.

So if we look at these metrics,
that is the staff turnover rate.

We are at historic lows
when it comes to staff turnover.

Now we we don't want to be at zero.

We do want people to go on
and have a wonderful career.

And we believe
in their professional development.

That was always a mission in academia.

People that we loved, we would work
with them and have a great experience. But

ultimately we do want them to do what's
in their own professional development.

People move, they get married.

They're different things that happen.

So we're going to normally
have a turnover rate of staff.

That's okay.

We've got 
plus new scientists coming on board

and it's good to have fresh scientists
come on with the new perspective.

And so it is healthy
to have some turnover.

But we are at historic lows when it comes
to the staff turnover rate at the FDA.

Now there is probably some uncertainty
early on when there was the restructuring.

I'm proud to report
now that the culture is strong.

The other surrogate marker of workplace
satisfaction, in my opinion,

and the turnover rate is industry recusal
among FDA staff.

So how many staff at the FDA
have a recusal with industry,

which typically they will put into place
if they are looking for a job?

Well, those recusal is demonstrated
here in this graph

are also weighed down significantly down.

And there they had very,

significant lows.

So, thank you.

This is your work.

I my job is to advocate for what

people need here, to,
to respond to the needs here, to advocate

for the staff here, to make sure
the staff have all the resources they need

and to take the good ideas from the staff
here,

take the good ideas that we hear
from those who interface with the FDA,

take the new technology
that's out there, including AI,

and to set the vision and to help

foster a an adoption of new ideas.

But these ideas,
many of them are your ideas.

Now, we've done a lot to invest
in the people here.

We are not only hiring,

plus scientists,
but we are, investing in that community.

We are paying people more.

We are doing things that are fun.

We have family Day.
We have bring your kid to work day.

We have, I think the Orioles and Nats

are playing, and we're going to have FDA
night at the stadium.

We have farmer's markets
now twice a week, when the weather's nice,

as long as it's not hail and sleet
and freezing outside.

And so we want to keep going
with all these programs.

We've extended the hours
of our cafeteria service.

So, when there is a need,
please let me know.

Let the leadership team know,
and we want to respond to those needs.

We are also doing

a lot to consolidate the technology.

What we found when I came here is

there were a lot of clunky services
that were built in isolation,

a lot of silos.

And so those silos resulted in multiple

licensing agreements
for software for the same software.

They resulted in systems that didn't
communicate between the different centers.

And so we've had an amazing, team
led by Jeremy Walsh

to consolidate,
consolidate the application portal.

We had different application portals.

Now we have one.

We had multiple ways

to study drugs in the real world,

and we had between the three systems
that were very clunky.

We now are moving to one system

and the adverse event reporting,
which is a staple of the FDA.

Many people look to our reporting
and event rates as a indicator

of what's happening with a cosmetic
or a product of any sort.

And so, we took these multiple

adverse event reporting databases

and really combined them into one system

FAERS, VAERS, CAERS, AERS

MAUDE, why do we have so many different
adverse event reporting systems?

And we did our own analysis.

% of people,
or to %, depending on on the system

when they go in to start
to report an adverse event, they give up.

It's just too long and complicated,

and it shouldn't take minutes
to report an adverse event.

It should have a great user interface.

We're going to have that now
with one adverse event reporting system.

We also save a lot of money
with these better systems.

And so the total savings we're going to
see next year is about $million.

What are we going to do with that money.

We're going to invest it
in our community, in our people,

and we're going to help be well resourced

to implement the aggressive reform
agenda that we've laid out.

Here's another indicator.

This is the number of visits

to our adverse event reporting databases.

Okay.

The number of times people are going there

to either check something
or look something up.

Now, in when we implemented

this consolidated,

database with daily outputs, that is

we used to report adverse events.

Or you could pull them by quarter.

You can now do it on a daily basis.

And so when that daily

reporting out or the ability
to pull data out on a daily

basis was implemented,
we saw a ton of visits.

And at the same time,
the exact same moment, we saw a massive

decline in foyer requests
for the same information.

So I know Tiffany loves foyer requests.

Thanks for your good work
on that, Tiffany.

So what you are seeing here
is just a common sense technology solution

to get away from the mundane work of
just going into our own clunky systems

and pulling adverse event rates
to then satisfy a FOIA request.

Those doing the FOIA request,
which, by the way, are some hedge funds

and others who are trying to figure out
whether or not a product is going to

have problems in the market or not.

And they're, you know, getting this
information to plan their investments.

I got to give them some credit,
not my thing.

But, you know,
that's what they were doing.

Well, they can do that now, faster

through this daily direct readout

and then digitizing our

applications, the paperwork that we have,

up until the s, we were still

accepting a fair amount of paper
applications,

plus pages
for some of these applications.

What have we been doing with them?

While we've had six warehouses,
air conditioned

with staff to just store all this paper?

So we're digitizing them.

We are moving into the next century
or catching up, and we are now digitizing

about million pages per week.

And the rate is increasing.

And what the goal is, is to close

these storage facilities, reassign
the staff to other work

and to save money that we can use

to invest in our scientific community.

So that project is going very well.

And by the way,
it can be used to train AI, when you have,

digitized applications now,

it can be used for machine
learning with the consent

of the owner of that information,
which is the sponsor.

We don't do that without,

the sponsors approval,
but we are planning to ask companies,

would you like this information to be used

in an anonymized way for machine learning?

And you would also have access
to the benefits of that machine learning.

So that's an option.

It's totally voluntary,
but it's something we can only do

when we have digitized records.

Okay.

These are other reforms that
we've announced in the last months.

Going from to clinical trials.

It's something that I believe in.

It's something
that will take a little time to implement.

There's guidance that's given out with,

companies
recommending to clinical trials recently.

It's going to be something
we have to phase in.

We are working on the formal guidance

process to change the formal guidance
from the agency.

We're working on internal training,

by the statistical team here at the FDA.

They're very passionate.

You can achieve the same statistical power

with a well-designed,
well controlled, appropriately

powered,

single pivotal
trial instead of two pivotal trials.

It's really just a math thing
whereby you can achieve the same

statistical power.

So, that is going to be phased

in over the next six months or so

and that we've gotten a tremendous
positive response from the industry.

One individual told me,
we'll be able to run

twice as many drugs
through a pivotal trial,

with this new reform.

Okay.

Again, lowering R&D costs,
which will translate

into lower drug prices
for everyday Americans,

we want to eliminate all unnecessary
animal testing.

A lot of it's unnecessary,
especially with new technology,

especially with common sense.

Do you really need
two species of animal testing

when a drug is already approved
in widespread use in Europe?

No, you don't.

So that is part of our roadmap.

We also announced you no longer officially

need animal
testing data for monoclonal antibodies,

where you have good,
alternative methodologies.

You don't have to test the monoclonal
antibody

on chimpanzees.

You can now submit computational modeling
organ on a chip

technology or whatever else is relevant
as a part of our new roadmap

to eliminate unnecessary animal testing.

And so just recently,
we had another major,

announcement,
a milestone in our on our roadmap.

And you're going to see more and more,
changes here.

The guidance,

is, draft guidance is now out

on these new alternative methodologies.

We announced the plausible mechanism
framework for ultra rare diseases.

I want to thank Doctor
Prasad for his work on this.

This was extremely well received,
especially in the rare disease community.

If there's a plausible mechanism

and it's not feasible to do a randomized
controlled trial, we have to use

common sense and we can do that in a way
where we are still evaluating safety.

And so, that is something
where we have already, had an experience

and, we

have the success story of Baby
KJ to show for it.

We want to see more Baby KJ.

That is Baby KJ for some of you
who may not know,

had gene editing done
as an infant, for an ultra rare disease.

That's the kind of thing
where we had a great partnership

with the doctors involved
and a great outcome for the individual.

We made our decision letters public,

thanks to Tiffany and others
for helping with that.

And this,

I don't know if the power is running low,
but we are, But,

it looks like it's holding here, so, we

released, our decision letters

that are what we call the CR
or rejection letters.

And I think that was widely

well received in industry
and among our scientists.

Sometimes our scientists take a beating
because they can't really say anything

about a drug
that may not be approved for good reasons.

You know, we don't typically engage, on,

by disclosing things
like safety, manufacturing violations,

if there's fungus growing in the facility,
if there's a major safety issue

with the plant,
if there is a clinical trial

that completely failed in its primary
and secondary endpoints, and,

people are wondering,

hey, why is this medication not approved?

Now all of that information is disclosed
in these public CR letters.

If we don't accept a medication

in whatever round that it's submitted,
the public deserves to know why.

It creates some accountability
for us at the FDA.

It also helps drug developers
understand how the review teams think,

what they look for.

What are the common reasons
why medications

may not be accepted?

Again, we're at near, record high levels

of approvals, but,
if we do not approve a medication,

the public deserves to know why
we want to see more approvals.

At the same time, we need to follow
the law, which says very clearly

that there has to be, quote
unquote, substantial evidence

to support, safety and efficacy.

So we are,
I think, doing, an impressive job

and this is part of our broad
transparency agenda,

-OH, which is an opioid
that's showing up on streets in America.

People have not called it an opioid.

They don't even know what it is.

We really were the first to go
very public to say this is an opioid.

It's -OH and it's derivatives.

They go by many names.

These are synthetic,
concentrated, forms of -OH

which is also found in the kratom leaf.

We are not focused on the kratom
leaf or kratom plants.

We are focused on the synthetic -H

that is made in laboratories at high
concentrated levels.

That is killing Americans.

And it may not show up
in the autopsy reports.

It may just be chalked up to fentanyl.

But this is a new synthetic opioid.

And we, for the first,

I think, time in history, have called it
an opioid.

It binds to the mu receptor by definition.

That's an opioid.

And we've been working with DEA to get it
scheduled as a controlled substance.

It's been off the map,
but we are raising awareness around -H

because we don't want more kids
to die from it.

So some of the really good work

I want to just quickly mention
some of the additional reforms

that we have implemented
in the last months.

We removed the black box warnings

on hormone replacement therapy to tell
women the truth about the short term

and profound long term public health
benefits of hormone replacement therapy.

Demand for hormone replacement
therapy has surged since our announcement.

We had over million,

visits and views across our different
social media platforms on this,

public event, an announcement.

We want women to know the truth.

million women have been denied hormone

therapy or never offered it
or talked out of it over the previous

years because of the fear machine
scaring women away from it.

And the FDA is guilty.

They piled on at that time,
about to years ago

by putting these black box warnings.

We are now using science
and not dogma to base those warnings. So,

huge, huge, tremendous positive feedback.

We also have new guidance
on wearables and,

devices that use AI

to have clear lanes for what's regulated
and what's not regulated.

We have a pre-check program for domestic

manufacturing to encourage
new manufacturing in the United States.

We are also announcing incentives
to move particular

manufacturing lines
from overseas to the United States.

And we are, as you saw,
released a new food pyramid.

So, people said, you guys do that.

And I said, yes, remember,
this is the Food and Drug Administration.

And so we worked very closely with USDA.

Secretary Rollins
has been a great partner at her team.

And so I'm very proud of the new food
pyramid that we were able to put out,

which is essentially

a procurement document
for school lunch programs in the military.

So now they can use taxpayer dollars
for food that we can agree

based on the best
nutrition science is real food,

not just food like substances
or whatever else we've been buying.

We are modernizing infant
formula, changing the monographs,

and we are allowing real world evidence
to be admitted into applications.

We've announced this intent.

Real world evidence is not necessarily
great evidence, but it is evidence.

And companies should be at least allowed
to submit it as part of their applications

instead of the onus requirements
that we've had,

limiting what type of evidence
you're allowed to submit.

Now, the biggest

threat that we have in
the drug space is China.

China surpassed us around to

where more clinical trials
were being done in China.

And if you look at the initiation

of a phase one trial,

they are about four times more in China

than the United States
the year before I came to the FDA.

This is a significant issue
and we can't ignore it.

So we have a problem

that we have to acknowledge
and we have to address

by reevaluating

what we are doing
that makes us noncompetitive.

And so that means we look at everything.

Everything needs to be on the table.

So if you look at the entire drug
approval process,

we have examined
this process, sent teams to Australia,

which is a country
now taking phase one trials,

in lieu of United States phase one sites

and asked, what can we do differently

to modernize and streamline the process,
to increase the user interface, to partner

with industry, to have, the FDA
as a regulator, work with them

along the process
to increase communication, to use AI

and whatever else we need to do
to make this process more efficient.

We're doing it, number one, for patients
towards our broader

mission of more cures and meaningful
treatments for the American public.

And number two,
to be more competitive internationally.

So we are looking
at each of these phases now.

These are broadly the reforms
that we are exploring with each of these.

Some have been announced,
some have been successful.

And some are in the planning
and exploration phases.

So in the pre IND process right now
it's days

between the average pre IND request

from a sponsor to meet with the FDA

until the IND itself is days.

This section right here.

Well in China it's about days.

And they just announced
they're going to go to

Can we partner with universities and CROS

and others who can coach sponsors
through this process.

Can we do a pilot in that space?

We have a team working on that.

Can we reduce the requirements of the IND

And they really have not been updated
in decades.

And I was just going through them with
Grace Graham, our deputy commissioner.

And some of those requirements
are just outdated.

We have to be efficient.

We should not be requiring things that are
not central to safety or efficacy.

So we are changing the requirements
on the IND and itself.

On the phase one trials, many

of those are delayed
by hospital contracting.

And because IRBs are not turning around
approvals quickly,

some institutions do

not, recognize central IRBs.

They use their own

in-house IRBs that are about they
take about two and a half times longer.

And if you know anything about these IRB
committees,

they often meet monthly with a group
of volunteers from the hospital.

Well, I remember it took a year and a half

when I was at Johns Hopkins
to get a study through the IRB.

If you think about it,
the entire U.S research

infrastructure is dependent on this rate
limiting step.

That is log jamming.

Researchers and making us

noncompetitive with IRBs overseas
so we can run

ethical IRBs in the United States
by having a different process.

Maybe it's paying members of the IRB,
maybe telling the universities it's

a part of accreditation,
maybe it's telling the universities

that you have to use

a central IRB or get the IRB turned around

with a decision
within, say, or days.

I don't know what the right solution is,
but we are

smart people in the United States.

We can fix this logjam.

We are losing business.

We are seeing trials go overseas.

These are drugs
that are ultimately used in US patients.

And so we're looking at IRB reform and
master contracting to help speed this up.

We also

are going to be launching real time
continuous clinical trials.

That is clinical trials whereby

FDA regulators get the data

directly from the electronic health
record, of course,

with the consent of the individual,
so they can see safety

signals and efficacy signals
and even use Bayesian analyzes

so that we can stop a trial
when we clearly see something's working,

or we clearly see a safety signal
and allow trials to be run.

Phase one, phase
two and phase three continuously

towards the broader goal of regulators
looking at endpoints in the cloud.

Now, again, this would be a pilot program,

but we are very close
to announcing a real time continuous trial

whereby sponsors can allow regulators

to see the data
as it is happening in real time.

We are embracing Bayesian

statistics that helps with optimal
dosing of medications.

We talked about going from to 
pivotal trials.

That all, really helps in the phase
three clinical trial.

And then we're going to narrow
this filing period from two months

to a couple of days.

We don't need a two month period just
to see if your application is complete.

So we're going to see this filing period
come down.

The review of the NDA
or Bla takes about a year.

We've seen
now that we can successfully get decisions

out in as short as days.

And so we need to make sure
we're well resourced

if we're going to be doing,
more priority reviews.

But, that time
period of about days is far,

faster than

the traditional priority reviews of,
say, six months or eight months.

And so again, speed is not the number one
priority.

Safety is.

But if our review teams
can cut the idle time,

then let's take advantage of that concept.

We're also allowing the manufacturing
CMC portion

of the application to be reviewed
before the clinical trial reads out,

if you remember, and certain applications.

So for example,

in the past,

everyone's waiting for the clinical trial
to read out.

And then once it reads out,
we get a giant application.

Well, we can review most of that before
the clinical trial reads out.

So if we can get the lion's
share in the door

and this is an offer to industry,
it's not a requirement.

If they want to get, the CMC portion

in or have inspectors go to the facility
and our new sort of expanded

pre-check program,
then that can help save time as well.

And then there's the post-market
after an approval where we look

at the performance of drugs,
we can do much better on that.

We shouldn't be learning.

Five years after vioxx was approved,

that it may have killed Americans,
or we shouldn't be learning

that OxyContin may have killed
half a million plus Americans.

years or years later,

we should have eyes on a drug immediately
after it's approved.

We can do this now with big data.

This fits our broader tech
big data platform agenda, and we can have,

eyes on every single drug that's approved,
not just,

do an expedition
looking at a single drug or device.

So that's a broader

view of
where we are going with this process.

Now, I'm
going to lay out a couple specific goals.

Of course, we have dozens of goals,
but here's a couple, simple ones.

We want to reform the IND
and phase one process.

And this is a focused effort.

We want to see more drugs
over the counter.

Why do you need to sit in an urgent care,

facility when, you know

you need a certain medication
or your doctor has told you, but,

you don't have a way
to get the prescription or,

you have nausea,

and you know that nausea medication helps.

Do you really need to go to weight
in an emergency room

and get worked up with the kitchen
sink of tests,

only to get a medication that you know
you may need?

So by moving medications over the counter,

we think we can lower health care
utilization, save people money.

And also

there's something magical

about a medication being on the shelf
because it has a price.

So people don't have to,

experience the money games, the shell game

behind the pharmacy counter
of the pharmacy benefit managers.

And so price transparency does

keep prices in check
for consumers broadly.

And it also enables
competition of different products.

So there's a lot a lot of benefits.

Over-the-counter drugs I would like to see
vaginal estrogen and several

other medications go to over-the-counter
this year.

We'd like to see inspections
of manufacturing

plants
go to one day as a screening inspection.

We don't need to be there for or weeks
routinely.

We can do a one day
safety review, look for major flags,

and if the inspectors
see something that is concerning,

they have the right to expand
the inspection to take longer. But

we can get through a one day inspection
checklist to do more inspections.

Surprise inspections
and have a better yield.

We're also using AI to hone
in on high yield targets for inspections.

If a facility has had a perfect track
record for years,

that is a low yield place to inspect.

If, another place has many indicators

that may warrant a close review, that's
where the AI helps us hone in.

We're using it for food inspections.

It's worked very well,
and we're going to be doing the same

for manufacturing of drug inspections,

real time continuous clinical trials.

We talked about that.

And beyond this year,
I would like to see as a broader goal,

a cure or powerful treatment for type
diabetes.

We are talking to the scientists
and learning

about what's early in the pipeline.

It's one of the best parts of this job.

And to hear what's out there,
if there's something that looks promising

in early studies,
we want to be very involved

and watch that technology
and usher it through

if it ends up, being promising.

And so not just type diabetes,
but I'd like to see

a powerful treatment for ALS.

I believe we can get there
in the next couple of years.

Not just to slow down
neurodegenerative conditions,

but to halt them
or reverse the progression altogether.

I'd like to see some of these powerful
cancer drugs getting through the system

so that people can experience
the benefits.

Metastatic cancer, certain types of,

microsatellite instability, GI cancers.

We're now seeing PDinhibitors,

result in a

complete elimination of the cancer.

Surgeons are seeing these tumors disappear
over the course of treatment.

They no longer need surgery, chemo
or radiation

in the case of some rectal cancer.

So that's amazing.

That's amazing on many on many levels.

Not only is that a miracle
for those suffering, it reduces downstream

health care utilization
and all of the morbidity and disability

that comes with some of these operations
operations I used to do.

So. This is exciting.

We want to see more cancer cures
and more cures across

many of the conditions here, be it
pediatric kidney disease, be it,

autoimmune diseases.

We're on the brink
of some major scientific discovery.

We should be ushering
in those potentially promising treatments.

I think we can get to a universal
flu shot.

So you don't need to every year,
come in and get your flu shot.

We're
not very good as a medical community.

And guessing which strain
is going to be dominant because the

polymerase on influenza is very flimsy.

And so it mutates at a much higher rate
than, other viruses.

So we're just it's just not a good system.

And flu takes tens of thousands of lives
typically each year.

I think we can see a universal
flu shot with long term protection

that will even protect against strains
that have not yet

mutated in nature.

And finally, I think we going to see

some powerful treatments
in the space of aging.

Now, some of you may not want,
certain individuals to live long,

but they may have the opportunity
to do so.

So in summary,

and thank you again,
Doctor Butler, for this amazing call.

I'm going to show
it off at every opportunity.

The FDA is doing very well.

We are strong as an agency.

We're going to continue to be strong.

We're operationally strong.

We are going to use evidence and science

as the core foundation of our decisions
here, not politics.

And we are going to aggressively modernize

the agency with AI and other technology,
ultimately with the broader goal

of delivering more cures and meaningful
treatments and healthier food for children

and a great workplace environment
for the staff here.

So I want to take a moment

and just thank all of you
for the incredible work that you've done.

I want to mention some of you by name,
but it'll be at the risk of not

getting everybody I should,
but thank you for all your great work.

It's been a great year.

We've had some challenges early on,
but it's been a great year.

We've performed well
and we're going to have a great next year.

So thank you.