Welcome to the FDA Direct Podcast
Unscripted, no make-up, live from the FDA.
Welcome Vinay Prasad, great to see you.
It's great to be here, Marty, It's great to be joining.
And we got Sanjula Jain-Nagpal, who is an awesome PhD health policy
expert who is with us in the Commissioner's Office.
So great to see both of you guys.
And I don't know exactly what we're doing, but we're having a conversation and this
is just going to be some civil discourse here, having fun.
And I think it's good for people to see what we're talking about,
how we're thinking about things instead of the FDA kind of being a black box of,
you know, what's going on inside the agency?
Absolutely, Marty.
I think ultimately the FDA serves the American people.
And it's really great for the American people to directly have access to the
commissioner to hear what you're thinking and what initiatives you're sparking here.
And too often, so many articles about the FDA are behind
a paywall for industry insiders only.
And we're going to try to make the FDA accessible to the average person in
America.
The glass box.
In the glass box here with a beautiful view of FDA campus,
not the black box.
Look at this beautiful campus here.
It is going to be lined up with a farmer's market on Tuesday.
Thanks to shout out to Melanie, who's in the background there.
And it's going to be every week.
We're going to do it every single week.
Maybe even some seed oil free food trucks, who knows?
Well, I mean, obviously healthy food is an important
initiative that you're taking on.
Yeah, big part that's part of what you're
working on Sanjula, is healthy food.
So we're, yeah, we got big, big goals on that front.
So it's great to have Vinaya Prasad here, one, because he's a great scientific mind.
Two, he wants to serve our country.
And three, he thinks and looks like Albert Einstein
in terms of his hair.
Now that you say that, yeah.
It's the regulatory haircut. It's the regulatory ... regulation, yes.
But I'm excited to be here and to join FDA and try to work in service of
American people and try to bring innovative products to market.
And you're going to be working at CBER.
You want to tell folks what CBER is since we've got some science people and some
non science people listening?
I mean, CBER, we govern a huge portfolio of medical
products, including vaccines, gene therapy, cellular therapy.
A lot of the most innovative things you read about in the news are things coming
from CBER.
Not to say the other departments here don't do innovative products, they do.
But I think I'm particularly excited about what's been coming out in the last
decade through CBER division.
And we hope to, you know, always strike the balance between data,
evidence, innovation and entrepreneurial spirit of
America.
So that's what we're going to do.
Does it sound good to you, Sanjula?
Sounds exciting, although I have a lot of questions about
how you're going to approach it.
OK, so tell me. So you know, there are a lot of headlines out there
about you being, you know, kind of a critic of the administration
and kind of how things have been handled in the past with a lot of those products
we talked about and that maybe you're anti-vax, but I know that that's not true.
So tell us a little bit about what you know why, why have you been critical,
particularly in the vaccine space and help everyone understand, you know,
kind of your thinking behind that?
So I mean, I think vaccines are like drugs,
which is that when given at the right time and the right moment to the right
person, they're life saving.
But just like drugs, they need to be evaluated on a case by
case basis and always taken to the context that you're giving.
And Marty and I, throughout the pandemic, we were proponents of vaccines for the
people in whom it had a huge benefit, but we were always a bit skeptical from a
scientific standpoint about perhaps overdoing it in some low risk population.
Wait a minute, you don't think a healthy, thin 12 year old girl needs a seventh COVID shot?
Seventh versus the eighth versus the ninth versus.
I mean, it's a, it's really. It's an unknown.
It's an unknown.
And it also is a way in which the United States has never been in line with peer
nations across Europe.
And so that's not anti vax.
It's pro science trying to bring the best available science to answer these
questions.
You know, the media in many cases, in my opinion,
they they sort of misrepresent the concepts that we're talking about at FDA.
They have sort of a superficial view of what we're doing and in some ways they
kind of missed the mark.
But in terms of, you know, what I've been doing for 15 years,
I'm a professor, I'm a "hemo" doctor
Probably no one's given ... or few doctors have given as many
vaccines as I have because I took care of a lot of patients post-autologous stem
cell transplant. Immunosuppressed.
We gave, you know, and you need to give these patients
vaccines.
So we love vaccines when done right, when given appropriately,
when based on solid evidence and we're going to hold up that standard at FDA.
I thought your media coverage was actually good.
I mean, on the whole, it was good, which is ... you don't always see that
I wanted to have a low expectation and come in high.
Yeah.
But I think there are a lot of questions, a lot of excitement, enthusiasm.
I saw something this morning saying, you know,
the scientific community is finally seeing everything that both of you
championed, you know, early on during the peak of the pandemic,
right?
You were early tracking the evidence, and not everybody was on board.
And now they're seeing it.
But there was some kind of talk about maybe you've been unfair about how things
were handled, you know, from a policy perspective,
because in the moment of crisis, you can't, like,
you don't have time to collect the evidence.
So I think something I would ask both of you is,
how are you thinking about balancing kind of pace of innovation, right?
We've all been outside of government.
We've seen first hand, you know, innovation goes faster than the
government policy, right?
And I know that's something that we're all trying to work really hard to close
that gap.
But how do you balance speed with scientific rigor to your point about
needing to get the right evidence in moments where you have crisis and things
that need to be acted on?
And in light of our new post approval monitoring process,
where we're going to be able to do big data analyses of signals,
safety and efficacy signals in big data after approval that we've never been able
to do before, that gives us a whole new lens that we've
never had.
Yeah, I mean, I think and to this point about what
Marty and I were arguing throughout the pandemic,
one point I want to make is that our positions were probably the center point
of most Americans.
And eventually a lot of the issues that we were out ahead of the curve on, people
have come to our position after six months or 12 months or two years and
forgotten that they held a different position all along. That's one.
The data caught up.
In other words, you're talking about prolonged school
closures, masking toddlers.
We were critics of these. Yeah, from the beginning.
And that speaks to how you appraise evidence,
not to get caught up in groupthink, try to be open minded when you look at
the evidence.
So that's one.
I think that the, the, the public is very close to where we are
on a lot of these issues.
I'm not sure about, you know, all the media coverage,
but definitely the public.
Should we invite some of the media to just be a part of this conversation.
And I think it'd be good to have ...
I think it'll be good.
... a reporter or a couple just, I mean, I, I think the more discourse the better,
right?
So they've got questions.
Probably some people out there in America have those questions.
Let's bring them in.
Let's have a conversation.
Let's bring them in right here.
Let's get another chair, put them right here and we have
conversation.
Love to do it.
And, you know, some of it is a matter of, you know,
how do you explain to the American people and to reporters what should the control
arm be in a clinical study?
How do we think about that?
What kind of questions are we answering with potentially different control arms?
That's something that was in the news a lot,
but I didn't see an explainer about what exactly,
what exactly the science is around control arms in, in clinical trials,
which goes back a long way.
So for those of us who are not as sciency, kind of in the weeds as you are.
Yeah, laboratory science.
Sorry.
Good point.
Break it down.
So are you saying that we've made decisions like ... no, we,
this agency has made decisions rooted in evidence,
but you're talking about a different standard of evidence.
So explain that.
Well, I mean, I think ultimately there, you know, we,
we get excited about innovative medical products just as the FDA always have.
We all continue to believe in a flexible regulatory standard,
taking into account the context of a disease, whether it's rare, if it's dire,
we will continue to be flexible.
There's not going to be a light switch change here, but around the edges,
I think there were a number of missteps along the way.
I think the public recognizes those missteps.
That's why some products the FDA has approved, as Marty points out,
the majority, 85% of healthcare workers don't want a
booster that the FDA granted authorization for.
And we really aren't sure about kids and how many doses they need and healthcare
workers who just had COVID, whether they need another booster.
And these are important scientific questions that the public deserves an
answer on.
And there we might try to bring science to, to answer these questions.
I mean, I think of it as gold standard science
and common sense, both.
We got to blend them both.
And there's no hard and fast rules on this.
And so, you know, I hear about these rare disease
conditions that might affect, you know, a couple hundred kids or, you know,
a small population.
And it's not that different from incurable cancers that I've seen in my
career, that you've seen in your career.
You're a hematologist- oncologist.
How do you think about those?
I mean, I think that you have to have tremendous
regulatory flexibility for rare diseases that severely impact small groups of
people.
We're running randomized clinical trials might be very difficult or impossible to
do. Perhaps.
And we need to embrace new technologies, innovative pathophysiology in terms of
how to assess those products.
At the same time, we also want to protect those patients
from potentially harmful products.
So we will continue to strike the balance at FDA between those two things.
And I think FDA has always been committed to being flexible and listening to the
communities impacted by rare conditions.
Some words of wisdom he's dropping here.
I mean, I'm excited.
I'm excited.
I wonder if these AI machines out there are really just Vinay,
if they're really just going to Vinay.
If he's the one answering all these questions.
Well, AI is a good topic because you've taken
interest in AI in the agency and you're doing some things around it.
Yeah.
Day one we said we got to stop just talking about AI,
having conferences and panels and frameworks and consensus document.
We got to do it, right.
We have to actually do it.
We got to do it and now's the time to do it.
So day one when I got in, gosh, 5 weeks ago now,
we started a massive initiative and we have now a,
the first high level AI assisted scientific review that just took place
and the scientific reviewer loved it.
I mean, I don't know if, you know, we can find him or pull him in here to
bring him on the camera.
But I mean what he said about, I don't know if he talked.
Yeah, I was reviewing some of the data we
talked about.
I mean, to go from, it was 3 days down to 6 minutes for just
one piece of that review process is tremendous.
I think the public that may not be aware, but when a reviewer is thinking about the
application for medical product, we're talking not just hundreds of pages
to read, but potentially thousands or maybe tens
of thousands of pages to read. And if you have AI brought into that to
help you dissect, to cut to the most important parts of it.
We can tremendously speed up drug regulation and drug processes.
And that's a boon to everybody, patients, industry, the American people.
Also let scientists focus on the science, right?
And kind of cut out that additional burdensome noise.
You know, I found in busy clinical practice.
What drove me crazy was not the hard work or the acuity of that work.
I love that.
I love hard work.
I love high intellectual work.
What drove me crazy was the stuff that was unnecessary,
the scheduling cases in the operating room,
that the burden of coding and documenting. It was things that were repetitive.
You'll probably still have some notes to finish.
Marty, you're not done.
No.
All my notes are done.
All my notes are done.
Yeah.
But it's, if you can, you know, I think of it,
if we can get rid of some of that redundant busy work,
it makes the job more enjoyable.
People need to focus on their superpowers here at the FDA.
And you know, I've heard reviewers telling me that
they're reading so many things.
There's just some stuff is just repetitive, right?
And if AI can create, grab all the unique facts and summarize
them for the reviewer and they love it.
Like the reviewer we spoke with or you spoke with,
maybe reviews can be done faster.
We can get more decisions, you know, decisions out in a shorter period of time.
And most importantly, they'll love their jobs more.
I mean, that's what we have to, that's our job as leaders to make a great
workplace culture for people where they can focus on their superpowers,
do their job, do their job well, support them,
not burden them with red tape and busy work.
And, you know, frankly, I mean, it's been, there's been some change here and it's
been tough for some folks.
It's, there's been some growing pains and, so what we can, you know,
my focus has been what can we do to empower people and give them all the
resources they need so they enjoy their work and feel like they're supported.
I think it's also an example of things you've been talking about on modernizing
methods and processes here, because as I talk around with individuals
across the agency, I mean, they tell me they were doing things that
have been the same for 20-30 years, right?
We live in this exciting era of new advancements and, you know, scientific,
you know, discovery and technology.
I mean, everyone's got smartphones now.
I mean, we consume information so differently and
we haven't really kept pace with that.
And so I think whether it's AI or some of the new kind of clinical methods and
think we're going to use to test things, that's all part of it.
We have to make our submissions easier.
We have to make it so sponsors don't have to fill out information over and over
again when they all told us once.
But you're absolutely right, you know, you just can't be the same.
You have to always be changing and adapting.
And too often in big institutions that doesn't happen.
Have you seen your new office?
I did see it, yeah.
It's nice.
It's got a good view here of the, the beautiful campus.
And I mean, all the offices at FDA are really nice.
And I do feel sort of an energy being here.
And I'm coming from a college campus.
So it's a very different energy.
It's a productive energy here.
Yeah, yeah.
I mean, I've loved getting to know so many people
here.
I mean, these are hard working Americans that
really want to do great things.
And it's just awesome to see how they've dedicated their lives to a job that is
not a high profile job, but so critical to our entire world of
discoveries and bringing cures and and they deal with for no credit sometimes.
So I mean, it's just been pretty cool to meet a lot
of these folks.
So if we get some seed oil food trucks with good food, they deserve it for sure.
We'll get on that.
Cool.
So I wonder if if you guys think it would be a good idea to do more public stuff
here.
We're at the, you know, main center part sort of the nerve center
of the agency.
People might be able to see on the camera the beautiful campus here where most of
the scientific review takes place.
What if we brought in, I don't want to call them stakeholders,
but we brought in different experts on different topics and just had an open
discourse.
Just bring them in.
Have a round table.
You don't have to go through all the red tape of, you know,
people coming through an official Commission,
which has a whole lot of bureaucracy and costs.
Or we just invite people in for a round table discussion,
let them talk passionately about all the scientific topics that they think are
important to talk about that we have not been talking about,
and then let that discourse take place and we can just listen.
And things that don't fit neatly within the drug advisory committee model topics
that kind of span different groups and different fields.
And I know you got a couple of those planned in the summertime.
Yeah, I think we're looking at some pretty cool
topics that are emerging in medicine and we'll probably set up a gosh,
we might be able to do a round table in a couple weeks.
I think I was talking to some of our folks back there and I think Bigfoot is
supportive.
I don't know where he is right now, but he's one of our AV experts.
Bigfoot around?
He's monitoring your audio.
Yeah, there he is.
And, and, and just so people know, we're not giving,
assigning you a nickname that you haven't assigned to yourself already.
Yeah.
Self appointed.
Self appointed.
And we have seen Bigfoot. For a while.
it was like steroids resulting in somebody improving in the ICU.
Like everyone heard of it, but nobody actually saw it.
And we called that, you know, it's like Bigfoot.
No one actually saw the ...
Ultimately everyone did see it.
But I think those conversations would be good to be more proactive, right?
And actually, you know, follow the evidence as it's coming out to
have those discussions in real time.
Yeah, proactive and discussions that include
the media that include patients, patient advocacy groups, the industry,
you know, having more of those here and experts
who've been studying these topics for 20 years.
I think it'll be good.
FDA, you know, to me as an outsider prior to coming here,
the closest I ever got to understand the thinking of FDA officials is to read the
rare JAMA viewpoint or to try to pour through, you know,
the letter that they're submitting, the company or the medical review.
And so I think it's a complete change of pace that you're going to be doing these
podcasts and videos directly to American people, to patients.
I think I haven't seen anything like that.
And I've been following the FDA closely for, you know, 20 years now.
We just got to talk.
We got to talk as we go, talk openly and honestly,
just share with people what we're thinking, You know,
within our legal constraints.
Obviously we can't talk about products that are currently under review at the FDA.
People ask, you know, what about this product and that product.
Well, you know, we have to follow the law, but we can talk about how we think about
things.
And I think one thing that that developers and inventors appreciate is
predictability. Understanding how we generally think about things.
Well, that's always a way in which I thought it
was unfair.
You know, in the one hand, the manufacturer of a specific product,
they get a letter, they can spin it and frame it any way
they want.
But the FDA can't reply in the press to try to clarify,
provide additional context.
So we are, in one way, we are a little bit of a disadvantage,
but we'll try our best to convey the broader principles of regulatory science
that govern not just any individual approval, but all of the approvals.
And hopefully the media will start to understand, you know, what we're doing.
There's there's often details in a product decision that the public is not
looking at or doesn't know about.
So it is pretty nuanced.
And I've even found myself at, sometimes saying, yeah,
that's strange that this got approved or didn't approve.
And then I, as I learn more, you realize there's actually a good
reason for it.
I would say FDA reviews are like a pomegranate.
There's fruit in there, but the heck of time to get it out.
And it sometimes feels that way.
But policy and science is nuanced, right?
It's not just black or white.
There's a lot to consider.
Exactly.
Exactly.
Which is why we should think of everybody as contributing valuable scientific input
rather than sort of a tribalism of people being for or against anything out there.
And I so that's the culture that I think we're
trying to build here.
So Marty, you had mentioned earlier you had some
limo story to share with you, but we didn't get around to it.
Yeah.
I learned that this is this is nuts.
I mean, there's a lot of stuff that I learned that is
nuts, but this is just a little Scooby snack to share with you.
So I learned that we'll have foreign inspectors in
another country about to inspect a foreign manufacturing site
that makes pills or something and the foreign pharma
manufacturing company will pick up our FDA inspectors in limos
And so these these visits are
so announced and they're preparing for these
visits that they're basically no inspection, in my opinion.
So this is like a priority administration, which is that if
you're doing the inspections in the United States you're held to
very high standards, including random spot visits, they don't
know it's coming.
But if you're doing it in some other locations around the
world, the standards are apparently much lax.
You get why you get a limo service there and they know when
you're coming, which, you know, like all great inspections, if
they know when you're coming, they know when to, you know, put
out the red carpet.
It's like when you came to my place the other day and I was
clean inside.
You know, it wasn't a mess because I knew you were coming.
Yeah, I get the random drop ins, you know, my
office right next door.
Well, I, I agree.
Like, the element of surprise is what drives the
power of an inspection.
And that's a big part of what the FDA does.
We've got over 300 officers with guns and badges
and many more that are involved in investigations.
The FDA has been involved in some major raids and some
investigations that have changed the industry.
The Elizabeth Holmes case is one example.
So scheduled inspection, in my opinion is basically no
inspection.
So that's something we're changing.
That's something we're changing where we're going to
move to surprise inspections overseas just as we have in the
United States.
No more limos for the FDA inspectors and so.
But they keep the badges. And they keep the badge.
I didn't get my badge.
I want a badge.
I don't know if you get a badge.
CBER is generally not a badge.
It's a badge free.
It's a badge free zone.
Yeah, I've got a badge.
I got a badge.
I'll show you.
So, yeah.
So fun.
So this is good.
Should we keep doing this or was this a colossal failure?
No, I think it's it's fun.
We'll see what people think with the video out there.
What's Bigfoot think?
Good.
Okay, he's on board.
Yeah, we'll put it out there and then we'll try
to do with reporters, we'll try to do them with the public,
we'll try to do with more people, and we'll talk about whatever initiatives
we're taking on.
We'll find a way to get the public to submit some questions and we can get a
sense of themes and we'll keep asking questions.
Yeah, we can see what the feedback is.
Maybe, somebody ask me to comb my hair
differently or comb my hair ...
I think I'm going to get that feedback.
I'm going to get that feedback.
Well, maybe.
Do you think Albert Einstein got that feedback when he would give a lecture?
I think he got a pass probably at some point.
I'm sure there's some some study out there about his productivity differences.
You know, the headline is going to read you
comparing me to Einstein, and I guess I'll take it if that's what
the headline reads.
Yeah, this is not Albert Einstein.
Let's just be clear.
However, his hair does have similar
representations.
And overlaps.
But no, it's good to see you.
Good to see you.
Welcome to the FDA.
I'm glad to be here.
Yeah.
And nice to work with you too.
Yeah, look forward to it.
Great.
Thanks so much, folks.
We'll do it again.
And it's really great for the American
people to directly have access to the