FDA Direct: Dramatically lowering drug prices for Americans

We're good.

When Bigfoot says we're good,
we're good.

And so we're doing this
now. Good to see you, Sanjula.

You too, Commissioner.

Busy week. Lots going on.

Always a lot going on.

It's a lot going on from all ends.

Yeah. Good stuff,
good stuff. So let's see.

We've had a lot of great meetings
and you've been jumping internal external

all over the place. So, we had a good CNPV.

We're making good progress
on the CNPV program.

Great start.  Really went very smoothly.

So I'm excited about that.

And the next group of medications
we’ll announce that will be recipients.

Right now

we're sorting through all the nominations
that come from the divisions internally.

So I'm excited about that. Good.

And then you also did some speaking at
the Association for Accessible Medicines.

Tell us about that.  
An amazing group of, largely biosimilar manufacturers.

I think they're about folks
there.  Amazing people.

I mean, I learn a lot

when we're out there meeting with people,
and I think that's important.

We need to be out there listening.

I mean, we need to be here working too.

But that balance of how much time
do you spend out there

circulating, versus spending here?

I think we hit a great balance this week
because we did both.

It's an amazing group of people.

We met with the board in addition to,

my meeting with the broader group
and speaking.

Yeah.

And so I think for our audience
who may not be familiar.

So let's unpack.

You know, you were there also to,
make an announcement on biosimilar reform.

So first, what is a biosimilar?

So look, a biosimilar is a,

a molecule that is

essentially a type
of generic version of a biologic.

Now, there's all sorts of people
that watch this podcast.

Let me back up for a second.

Health care costs are going up.

They talk about it
all the time in this town.

Health care costs are going up.

And the fastest area of health care
spending growth is drug price inflation.

And the fastest area of drug price
inflation is biologics.

It's now over % of drug spend,
even though biologics are about %

of the medicines prescribed.

Biologics are expensive, in part
because they're amazing.

They use cell lines to be produced,
and that's expensive.

So these are things for like cancer
and certain types of.

Autoimmune diseases. I’ve seen it used
in, post transplant recipients.

They're amazing medications.

They work wonders.

I had the privilege of seeing it firsthand
as a, as a clinician

when I was practicing.

So, look, we should all be thankful.

And the companies that,

bring biologics to market,
we should be thanking those companies.

They're not the bad guys.
They're the good guys.

But when that years of,

exclusivity expires,
we want to see low cost alternatives

come to market, the generic versions,
if you will.

And those are called biosimilars
when it comes to biologics, when it's

small molecules, we just call them
branded and generic medications.

But with biologics, there's this new class

that started getting approved by the FDA
ten years ago called biosimilars.

And they make drug, these biologic, drugs
at least the,

the, the, force of these
biologic drugs, the benefits,

biosimilars make

those benefits affordable to many people.

And that means they're more accessible.

So they're usually about % on average
of the cost of a biologic medicine.

Right? Yeah. It depends.

I mean, when Humira, a famous biologic,
had their exclusivity expire,

it took seven years for the first
biosimilar to come to market.

And then even when one came to market,
you didn't see the price budge

that much might have been.

Some have argued and implied price
collusion.

I don't want to make
that statement myself.

But once you started
having a couple three, four

biosimilars to compete,
you started to see that price come down.

Now, there are biosimilars that are sold
for a fraction of the price of expensive

biologics and biologics should be charging
what they need to recover R&D.

But sometimes the price goes way up.

When Humira came out, it was $

It was tens of thousands of dollars,
$

sometimes, over different points in time.

And so what is that
number needed to recoup R&D?

Look, we're not gonna 

get involved
in the price that companies set.

But we do want competition.

We want biosimilars on the market.

We want lower cost alternatives.

Because if the biologic
is incredibly effective for somebody but

they can't afford it, the effectiveness
for that individual is zero.

So to paint that picture then.

So for those who may have missed
the announcement this week,

so my understanding is that about % of
there's only % market

penetration of these lower cost
generic versions of the biologics.

And so there was a big reform.

You announced this week with draft
guidance.

Tell us about. That. Yeah.

So that right.

That's the money right there
I need to get right to it.

So and you're right,
first of all, only about % of biologics

that are going to come off
their exclusivity in the next ten years

have a biosimilar in development.

It should be % plus. And,

Europe has more biosimilars approved
than the United States.

And they got a year head
start on us as well.

They started earlier,
and there are more in Europe.

And so we have to examine
the regulatory hurdles

that are preventing more biosimilars
from coming to market safely.

And so we announced, this recently
at this conference

that we are going to be removing
some of those regulatory hurdles,

for example, the comparative study
that we've historically required.

We don't require it for generics,
small molecule generics.

We say, look, if it's the same molecule,

we are comfortable with that.

So we're going to take the to year

time frame for a new biosimilar
to come to market.

We're going to cut it in half.

It'll be, I don't know, two and a half
to five years.

The companies that we talked to at the
association, felt very comfortable that,

they're going to be able to

cut that time in half
given this new regulatory, draft guidance.

And then also with interchangeability,
we announced

that we're going to take a strong position
to support interchangeability, that is,

allowing pharmacists and patients
to make the decision together

to switch to a biosimilar
instead of a biologic,

if that's, desirable for the patient,
maybe all that they can afford.

Which does already happen
for a small molecule today.

Right.

Go to the pharmacy and your pharmacist
can give you that lower cost,

one that they can't for these others.
Right? Okay.

Now, look, I had heard from people in the
industry over the last several years

that the cost to bring a biosimilar
to market is about $million.

The amazing thing about listening
and being at that meeting, meeting

with the board
and the makers of biosimilars,

is that they were really specific
and granular on exactly how much money

this reform is going to save them in the
development process, as low as million.

But the most common answer I heard was
the number is closer to $million.

Now, for a medication
that costs between 

million to develop,
to million to develop.

Saving million is a big deal.

And when you lower these R&D costs,
it also lowers the price of drugs, ideally

because there's not
you don't have that cost to pass on

and recover
and the price of the medication.

So by eliminating that kind
of, study requirement, which we don't have

for the small molecule generics,
we're reducing the development costs.

That's a good thing for developers.

But then we're also going to

that's going to translate
down to the everyday American patient.

That's right.

So I think it's it's a win.

We've gotten great feedback on this.

And so just an exhilarating time.

But we're going to keep doing this stuff.

We've been thinking about it,
but we've got to socialize it.

Big shout out to Mustafa

and Sarah here at the FDA, who,

were very instrumental and, you know,
this is the way to do things.

You don't come in on day one
and just announce reforms.

You've got a make sure you're doing it
the right way and talk to the people

here, get everybody's input
and then make a decision. Yeah.

And it was amazing listening to you
give those remarks at that conference.

By my count, there were kind of three
kind of standing ovation.

Applauses. Right.

Because this was such a big moment
for the industry.

Right?

They've been waiting for this

and wanting for this for years,
and it's not been done.

So kudos to you for making that.
That was cool.

It was that was a great meeting.
It was great to get that feedback.

I'm most excited about its

implications for Medicare and Medicaid,

because once you start
seeing more substitution with biosimilars,

or at least allowing patients
to choose biosimilars,

and they're look,
there are very, creative ways

now that some insurance companies
are structuring your choice.

So if you choose the biosimilar,

you may have a lower copay
because they are saving a lot of money.

When you choose the biosimilar,
they may want to pass that savings on

in the form of the copay.

You could see lower health insurance
premiums as a result.

And so this fits with that broader mission
that we have right now

where we are hot to lower drug prices,
a ton for everyday Americans.

That's the most favored nation status.

Our work at CMS, it's our work to say,

if you can make your medication
affordable, we are going to favor that.

We're going to like that.

We're going to try to support that and to
move manufacturing to the United States.

So it really fits beautifully
with that broader vision.

Because if you think about what the the,

the world of health care talks about,
they talk about.

We have a broken health care system that

has a ton of waste.

And what the what the conversations
have been relegated to in the policy

circles is how much money
to throw into that broken system.

This is actually addressing
one of the root issues,

and that is the price of goods
and services and health care.

And the other piece, of course,

is the health of the population,
which is a big focus of MAHA.  

it's exciting.  And, you know,
I have to say, on the CMS point,

when you made this announcement,
you did it also with Doctor Oz.

Right.

And so,

you know,

that's great to see the two agencies
be aligned in trying to make

this actually happen.
He's an interesting dude.

Have you spent time with him?
Not very much.  

I mean, honestly,
one of the smartest doctors

I have ever met.  Was vice
chair of surgery at Columbia.

We had surgical residents go to Columbia

for their cardiac surgery fellowship,
and they would operate with him.

And because Oz started
getting into general health promotion

and doing things on television,
we were all curious,

how are Doctor Oz's technical skills?

And, you know, some people

might be jealous.

He's on TV.

You kind of want the answer to be,

you know, well, he's
not that great in the operating room.

No.  Our residents that went up
there were like, he is as smooth and slick

and technically savvy as any of the
greatest cardiac surgeons in the world.

And he actually trained,

I found out, and this all stuff
I'm learning spending time with.

He had trained
with Doctor Carpentier, with the greatest

cardiac surgeons
in the history of medicine.

And so he's just a fascinating guy
that's interested in psychiatry

and obstetrics and internal medicine
and autoimmune diseases and pediatrics.

And he's spent time researching all that
in the health promotion work he's done.

But he's also an incredibly accomplished
academic, physician.

So he's just a fascinating guy,
the smartest doctor I've ever met.

Yeah, well, it's a privilege for
people like me who get to be at work,

you know, with the two of you and,
you know, observe and learn a lot of this.

I mean, your recall of all these stats.

And I know we were prepping
for this announcement and, you know,

he was citing all these studies

he had just read.  I’m like,
when did you have time to read this? 

Yeah, yeah.

It's nonstop. Yeah.

But it's great to see the alignment.

And I think

that's going to actually translate
to lower prices for everyday Americans.

So he's committed and he's committed.

And we have a charge from this president.

This president's not

interested in reducing drug prices
by or %.

He's interested in massive reductions
where now Americans

can buy direct bypass
the middlemen of the PBMs.

And that's the basis of their TrumpRX 
curated website.

You can buy directly
from a pharmaceutical manufacturer.

Genius.

Now, like if you love PBMs

and you want to pay a higher price,
then that option will be there.

But now we have another option. Yeah.

And so that's exciting.  

So these have been some really big reforms
on most favored nation.

The biosimilar reform
all of this round drug affordability.

But there are a lot of other drug reforms
that you've really been

challenging the agency here
to be thinking about moving forward.

And some of them, you know,
the average person may not realize,

have an implication, right,
on getting development costs

timelines down and the costs down.

So, for example, just a couple days ago

we made this announcement
on filing checklists. Right.

Do you remember that one.
Oh yeah. Went so yeah okay.

I'll try
to explain this one to the general public.

So when you submit
an application to the FDA,

we spend up to two months
just making sure it's complete.  Something

and the tool we use
is something called a filing checklist.

So we now live in the modern era.

And so we can make this filing
checklist public.

So sponsors could have it and go through
it themselves before they submit it.

And also we can do this
in a much more automated fashion. 

But okay I guess we're running out of time
here.

Oh, okay.

I guess we got a meeting coming up. Yeah.

All right. Got a busy calendar.

The Galien Foundation forum.

That was awesome.

So, that was a great part of last week
and then,

the cancer CEO roundtable,
great to hear from the cancer center.

Directors sat down with them.

A bunch of them actually happened to be
in the same area of surgical oncology.

That's coincidence.
So I don't think that's by design.

Is there

anything that you guys talked about
that's kind of shaping your your thinking?

We talked about
the uncinate of the pancreas.

No, no.  We we talked about, look we talked
about health care costs and the struggles

they have
and how we can reform clinical trials

by having more streamlined
hospital contracting and central IRBs,

the amount of delays from the hospital
contracting process

and the decentralized nature.

When you want to run a trial in
eight centers, you got to do this

back and forth with each of the,
hospitals teams of lawyers.

And then the non, decentralized IRBs,

you know, their volunteer boards,
where you have

doctors sitting in a committee
once a month

and they, they don't get to it
and it gets bumped to the next month.

I don't know if I told you I had an IRB

proposal at Johns Hopkins
for a research study.

I wanted to survey a survey of patients,

and it took a year and a half,
and in the end, it was actually rejected.

Geez.

It was a survey.

Like, what danger is

that survey going to do is like a survey
on on their eating habits and patterns.

This was one of the reasons
I couldn't stay in academia,

because there's just so many paperwork
steps and things

you have to do just to be able
to do what you want to be doing.

You know,
I thought bureaucracy was really unique

to the government. It's not it's unique

to organizations proportional
to the size of an organization.

So you get it in any large organization. Yeah.

But, speaking of which, on,

the topic of nutrition,

we did meet with the American Heart
Association last week.

Great meeting.

We are, meeting with different
stakeholders around the topic of food,

and we are gearing up for the announcement
of our dietary guidelines.

We’re rewriting the food pyramid.

And we're going to do it in a way
that's much more evidence based,

not a food pyramid
that's written by industry,

based on the products
they want you to buy.

This will be based on some really good
expertise that we're getting.  

Good.  
And it's going to be exciting. Yeah.

I think it's amazing
that it's such a collaborative process

in getting input from all the relevant
folks.

We're trying to keep it short, like,
I don't know, or pages.  

And the current
one is a couple hundred pages. 

Yeah, I think, but,
if it's four, or pages,

you'll have a ton of people
read it and understand it.

If it's pages,
very few people are going to read it.

I think it's going to be huge
because those guidelines then determine,

you know, what school lunch programs and
everything else that follows from that.

Yeah.

Okay. Exciting time. Yeah.

Good. You've been busy, man. Your shifting a lot.

Yeah.

Good stuff.

Yeah. Oh, thanks for all your support
and help here, Sanjula.

So I guess they're pulling at me
to go to this meeting.

I hope it's a good meeting.
Do we have a minute?

I think there was one other thing
we forgot to catch up on.

Halloween.

Halloween. Flouride.  

Okay.

The best way to prevent
cavities is good dental hygiene.

The downside of infants
taking fluoride tablets

is that it's
now known to alter the microbiome.

That is, the garden of bacteria, billion
plus bacteria

that live in the gut,
that live in an equilibrium.

And it is increasingly recognized
now that the microbiome is a central organ

to health. And so many organ systems.

It's all about gut health. Gut health.

So I am, so it is

far better to engage
in good dental hygiene

than to simply send a fluoride tablet down

the GI tract of a child
when that microbiome is forming.

Given what we know now about how fluoride
tablets do alter the microbiome.

So we did, take action to,

say now that we no longer,

include in the label
an indication for fluoride

in kids under three or kids with access
to, dental hygiene.

Yeah.

And I know the team published
a big scientific report

that walks through all the evidence
around it.

It's really eye opening to see
some of the different studies there.

Yeah.

Look, they're all God's children
arguing about this issue.

But on one hand, you have a dental
community saying it reduces cavities.

And on the other hand,
you have people saying,

yeah, but we don't know what
it's doing to overall health.

And we do have studies
now that show kids that take antibiotics

in the first few years of life
have higher rates of, atopic dermatitis,

of of, of asthma, of obesity,
of other chronic conditions.

And it's believed

that one of the reasons
why that association was seen in the Mayo

Clinic study is that antibiotics
are also altering the microbiome.

And in fact, fluoride may be essentially
a bacterial cidal agent.

The same reason
it may reduce cavities or bacteria, kills

bacteria on teeth is it's
maybe killing bacteria in the microbiome.

Well, Thanksgiving dinner,
my sister is a dentist.

So we're going to be having this debate.

Good, good debates are good.
We love them. Yeah.

Good.

Well,
I know, it's also almost lunchtime too.

So last fun question for you,
since you're talking about the microbiome,

how do you keep a healthy gut microbiome?

Do you like eat anything in particular
or take probiotics?

I think whole foods, whole foods
bound to fiber, grains bound to fiber.

I think, I, you know, I generally want
as few chemicals in my food as possible.

And I think that sounds a little, cheesy,

but I think you want to avoid antibiotics
unless they're really necessary.

Antibiotic. The average,

ten year old in the United States
has already

had multiple courses of antibiotics.

Are they all necessary? No.

Study after study shows that
half of the antibiotics prescribed

are not clinically necessary.
That, that.

That's repeatedly established in the literature.

And we all know what's going on.

There's a consumerist culture.

So, so that's what I do.

Interesting. Great. Well, okay.
I've kept you long enough, so.

All right, well, enjoy your lunch.

I'm going to run to this meeting.

Great to see you, Sanjula.

Thanks, folks,
for taking a little time with us.

This is our fun part.

If we get done with our work early,

we say, hey,
let's shoot out here and just chat.

So this is the fun
part of the day. So thanks everybody.