FDA Commissioner Dr. Robert Califf Discusses the Top News Stories

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Speaker 1: Welcome to Conversations on Healthcare. This week we welcome FDA
Commissioner Dr. Robert Califf on challenges to drugs long approved for
medication, abortion, upcoming tobacco regulations, and FDA's quest to combat
misinformation. Now here are your host, Mark Masselli and Margaret Flinter.

Mark Masselli: Abortion rights have eroded in America since the Supreme Court overturned
Roe v. Wade. And right now we're seeing some of the starkest examples of this
reality. Our guest is one [00:00:30] of th e persons trying to navigate a rapidly
changing legal situation while keeping patients safety front and center.

Margaret Flinte...: Dr. Robert Califf is an accomplished cardiologist and scientist. In his second
stent as the FDA Commissioner, he previously served as the FDA Commissioner
under President Barack Obama.

Mark Masselli: Oh, well, commissioner Caleb, welcome to Conversations on Healthcare.

Dr. Robert Cali...: Good to be here.

Mark Masselli: Yeah. We'll start with the breaking news about the bans on abortion
medication, which is the [00:01:00] choice of approximately half of all
terminations in the country. 22 years ago, as you know, the FDA approved a
medical abortion regimen for up to 10 weeks into pregnancy. Now Wyoming has
become the first state to explicitly ban their use in the mail order option may be
at risk in Wyoming. I'm wondering what the Biden administration or what your
thoughts are in terms of communicating on this.

Dr. Robert Cali...: Mark, unfortunately, [00:01:30] in a case of pendin g litigation as it relates to
FDA, I'm not really able to say much about it. I'll just comment the FDA did its
review over 20 years ago. The science is unchanged, our decisions are
unchanged at this point. But because there is pending litigation, we'll hav e to
wait and see what the courts have to say.

Mark Masselli: Commissioner, as I think about that, there was a number of years that went into
that decision [00:02:00] 22 years ago. Maybe talk a little bit about the rigor that
went into that decision back 2 2 years ago.

Dr. Robert Cali...: Well, all of our decisions are based on the best available science. The data come
in, they're evaluated by civil servants who have no vested interest in any,
they're not political appointees. I'm a political appointee. I'm the commissioner.
So those decisions are made by career civil [00:02:30] servants who are
assessing the science. So science and medicine is what we go by and that's
where we were 20 years ago and where we still are today.

Margaret Flinte...: Well, commissi oner, if I could just pick up on that for a moment. FDA approved
really means something to all of us. I want you to know out in the world of
practicing healthcare, whether it's primary care where we are or cardiology
where I know the focus of your clinical career has been. [00:03:00] But I think

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people often are confused about where the sort of boundaries end with some of
these things.

My understanding is once the FDA has weighed in on safety and effectiveness,
right? The two big issues, that it's not some thing that could be overturned
externally. And I guess, the question is do you have the regulatory discretion to
avoid enforcing a ruling that goes against what the FDA has included? Just
educate [00:03:30] our listeners about that.

Dr. Robert Cali...: I'm afraid I can't really get into the details here because they're separate
branches of government. The judiciary is different than the executive branch
and there could be a variety of different circumstances. But so that's really all I
can say about it whil e the litigation is pending.

Mark Masselli: And we appreciate that and we have a lot of topics to talk about. But [00:04:00]
I do think it was sort of an unprecedented act where Walgreens indicated that
they were not going to make the drug available in 31 states. I'm wondering your
own thoughts about pharmaceutical companies or the large manufacturers
deciding which states they can sell FDA approved, forgetting this particular drug,
but just as a precedent I guess. [00:04:30] Has that happened in any other case
and...

Dr. Robert Cali...: Well, I do appreciate your interest and I do have personal opinions, but in my
role I can't really comment on these things at this point. I'm sorry. I look forward
to talking about it later.

Margaret Flinte...: Well, we look forward to future conversations and obviously we're following it
closely, but you do have a enormous span of issues that you're responsible for.
And one of them that I'm not sure the public has always understood is that you
have oversight of [00:05:00] in fant formula manufacturers and certainly very
much in the news this year was that the plants have been plagued by bacterial
outbreaks. I think that's led to some shortages in some areas. You've proposed
changes to the agency's human foods program to addres s the problem. Tell us
what you're doing. And does more need to be done even than the next steps?

Dr. Robert Cali...: Well, glad to talk about this. Infant formula course is a very precious [00:05:30]
component of a very large food system that we have. The food ecosystem that
we regulate has over 600,000 entities. I was just on a call this morning about
imported seafood safety, for example, where over somewhere between 70 and
95 percent of our seafood that we eat in the US comes from overseas. So it's a
vas t set of responsibilities that we have. But of course, infant formula is special
because infants can be totally [00:06:00] dependent on formula.

And as we ran into the problems that we had with contamination of a plant with
bacteria of one manufacturer, t hat was the dominant manufacturer in infant
formula, we had to stop production in that plant and entered into a consent
decree with Abbott to oversee the restart, which took several months. That led

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to a shortage. And it also [00:06:30] surfaced a lot of i ssues within our human
foods program. I have to say, upon being nominated, as you know, this is my
second time around at FDA. The first time was relatively.

Mark Masselli: Congratulations.

Dr. Robert Cali...: Brief before the election, I got a lot of calls from inside and outside the agency
that the foods program needed more attention and support. So I was ready for
it. But it turned out that recall at Abbott was on the day I was confirmed.

Margaret Flinte...: Wow.

Dr. Robert Cali...: So I was presented wit h this right from the beginning. [00:07:00] What we're
doing is restructuring the whole program to upfit it for the future. But one really
important point to make, which we didn't talk about much, right about the time
I was confirmed because you were in th e middle of a crisis with infant formula
that we needed to handle first.

The Economist did an assessment of all the countries in the world and we came
in third, right neck and neck with Canada and Finland for the [00:07:30] safest
and highest quality food in the world. Unfortunately, availability, we didn't
come in so high as a country.

And as you know, there are many factors beyond the assessment of quality and
safety, which is our mandate that come into play there. We have many
inequities in this countr y that we need to deal with. And so we're really putting
a lot more effort and energy into the program. We're elevating nutrition. We're
losing millions of Americans to chronic diseases that [00:08:00] have a
nutritional basis, as you well know.

Margaret F linte...: Yeah.

Dr. Robert Cali...: And we're also getting support from Congress to beef up our infant formula
program. We don't make infant formula, we can't tell companies to make it, but
we have a marketplace right now which is heavily concentrated and not diverse
enough, and in which we had very little ability to get insight into the production
that was going on. All the companies are now collaborating and our in stock
[00:08:30] rates are back up to where they were before the recall, but there's a
lot more to be done.

Mark Masselli: Commissioner, the diabetes drug Wegovy is FDA approved for treating obesity
and there's concern about the side effects even with the FDA approval and
acknowledged obesity issues in the country. Are the side effects worth it in your
mind to prescribe it as a physician? What would you be prescribing?

Dr. Robert Cali...: [00:09:00] You keep drawing me into this tricky position of I'm FDA
commissioner, so I have to be careful about being too opinionated right now.

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Mark Masselli: Yeah.

Dr. Robert Cali...: Relative to the role of the FDA. But I have a few things to say about this. You
know that we in more than almost any other country, are suffering from this
enormous amount of obesity, type two diabetes, hundreds of thousands of
teenagers now with type two diabetes. [00:09:30] And the biology of the weight
gain that we've experienced as a country has been poorly understood.

And I think as much as anything else, these new classes of drugs are giving us
insight into something that a few scientists knew about, but most of us were
oblivious to, which is that the connection between the gut and the brain that
affects our appetite is a complex neuro hormonal connection. And so these
drugs intervene [00:10:00] in those pathways.

And what I would say is that obviously the FDA has found one of the drugs to be
safe and effective, not only for diabetes, but also obesity. And there's another
one, which the data will come in soon from a large trials that'll give us the
insight that we need to h ave. I feel like this is going to be the beginning of a
revolution in the way that we control weight, not just with the pills, but because
we'll [00:10:30] understand the biological mechanisms better.

There'll probably be multiple therapeutic is including better use of the
integration of digital technologies and medicines. So would I prescribe it now
safe and effective for the intended population? I think the biggest issue in front
of us is going to come from very large trials that are underway about peopl e
that have obesity [00:11:00] but don't have diabetes.

And in that population, the results of those trials will tell us what we need to do.
If you have a reduction in death, a reduction in disability due to orthopedic
conditions or cardiovascular events, then by all means on average, the benefits
will outweigh the risk. But all drugs, all interventions, there are side effects and
toxicities.

We have to be aware of those as clinicians and we need to inform patients.
[00:11:30] The good thing about these d rugs, like many others, is that most of
the side effects are symptomatic. And so if someone's having symptoms of side
effects, you can stop the treatment. That's kind of a nice quality of this kind of
intervention.

Margaret Flinte...: Well, we look forward to results of that further research. And as with the
National [inaudible 00:11:53] project, we certainly hope that it embraces people
of all backgrounds, ethnicities, races, when that research is done so [00:12:00]
we have a good understanding. But I have to say it's March and I don't think I'll
ever experience March again without thinking of it as the month that the COVID
Pandemic started.

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Three years ago now. A little more at least in our rear view mirror. But you've
been proactive, I think, about how i mportant it is that people get the COVID
vaccine, that they're safe, the treatments are effective. And I read that you
actually [00:12:30] reached out and sent an official letter to the Florida Surgeon
General about his views being very public that the COV ID vaccines could be
quote "Harmful." Have you heard from him? Did you get a response? Do you
think that there'll be a change of position on that?

Dr. Robert Cali...: I wouldn't expect a change in position. Dr. Ladapo sent us a letter, so we were
just resp onding to his letter. And his letter indicated [00:13:00] that maybe we
weren't paying enough attention to the side effects which are recorded in the
Vaccine Adverse Events reporting system and other places. We just responded
saying we are paying attention .

All effective interventions have side effects and toxicities, and we need to care
for people that are unfortunate enough to have those and try to understand
them better. But in the case of vaccination for COVID, the vaccines have an
overwhelmingly benef icial effect on reduction in death [00:13:30] and
hospitalization and a modest effect on transmission now.

And initially, as you may remember, when the vaccines were first developed,
they had a huge effect on transmission. But as the variants have come al ong,
that effect is smaller and wanes over time. But the effect on being dead, I'm a
cardiologist, I'm used to dealing with life and death, almost everyone would
rather be alive than dead. And you have a free simple intervention.

And we made the point tha t while we should be aware and pay [00:14:00]
attention to side effects and toxicities, if we do that and don't talk about the
benefits at the same time, we could be misleading people into avoiding getting
vaccinated, which would be avoiding a life saving intervention.

I used to spend a lot of time convincing docs to give, to open the artery of
people with heart attacks and feeling that if you had someone with a blatant
heart attack and you didn't open the artery, [00:14:30] you were subjecting
them to the risk of dying unnecessarily. And I think the same as here. So I don't
expect Dr. Ladapo to change his view, but we felt it was important to respond to
the letter that he sent us.

Mark Masselli: I want to stay on that theme of misinformation in COVID becau se you've been
very clear that almost no one in the United States should be dying from COVID,
but misinformation really is impacting the death toll and the FDA is more
aggressively trying to stop [00:15:00] misreporting incorrect social media. I
know this is very important to you, but is a more proactive approach needed?
And do we need to go after the social media algorithms that spread this
information? Because as you noted, it's a matter of life and death.

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Dr. Robert Cali...: I think this is one of the mo st important problems we faced. I've publicly said, I
think misinformation is actually the leading cause of death in America now
because [00:15:30] so many people who die could have done things to change it
had they gotten better information in a way which motivated them to act in
very simple things like taking proven medications to prevent cardiac events, for
example.

And certainly vaccination is another example of the same thing. But this is a very
complex and difficult issue. We're in such a different environment now
[00:16:00] with the advent of the internet and the use of algorithms in social
media. It's just an article last week that really got my attention that
demonstrated a social science article that if the headline of an article has a
negative w ord in it, it gets more clicks than exactly the same headline without a
negative word.

And so there's also an article that shows that physicians are just as affected in
their recommendations by [00:16:30] which news outlets say watch as
laypeople are. So these things are telling us that if we believe that a federal
agency like FDA can just make a determination and put out one statement and
things will happen, that's a very naive perspective.

On the other hand, we highly value the first amendment and the r ight to free
speech. So finding where that appropriate middle ground is [00:17:00] really
difficult. And I'm not arguing that we know that right now, but we've got to be
constantly working on trying to get accurate, reliable information to people.

And her e I'm glad we're on, whether it's physicians, nurses, nurse practitioners,
physicians assistants, pharmacists, we really need everyone to pick up their
activity on this and make it part of every day. [00:17:30] Because in the same
way I described it for fe deral agencies in, I worked at Alphabet between my two
FDA stents, and it's really obvious that if you think that people are coming in just
to listen to you for 15 minutes and then to go out and do what you say with no
other influence, you're out of your m ind. The minute they're out that door,
they're Googling and looking at...

Mark Masselli: Yeah.

Dr. Robert Cali...: Other information and hearing from relatives. And if you don't ask them
[00:18:00] what they're thinking and what their information sources a re, you
may never know that they didn't do what you advise them to do or what you
thought they had agreed to do because they were influenced by some
influencer that you'd never heard of.

Margaret Flinte...: Well, commissioner, maybe that ties a little bit to this next question that I
wanted to ask you, but I've been reading some and really appreciating the
health equity lens that the FDA seems to be taking towards tobacco [00:18:30]
regulation and prevention efforts and that recognition of just another huge

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disparity between who is starting to smoke these products at what ages and
what communities they come from. Maybe you could share with us a little bit
about what we might expect to be hearing more about or seeing over the
coming months in terms of labelin g and messaging from the FDA about tobacco.

Dr. Robert Cali...: Here, this is really a tough [00:19:00] one. And I grew up in South Carolina, in
North Carolina. I've was a cardiologist at one of the busiest hospitals in the
Southeast and saw many people di e or have lifelong disability from tobacco.
We're going to lose almost 500,000 Americans this year from tobacco related
illness. When I came to FDA in 2015, I sort of felt like we understood this
problem and we had it under control. It is getting better.

[00:19:30] We have about half the rate of use of combustible tobacco that we
had when the Center for Tobacco products was started at the FDA 13 years ago.
But we got a long way to go. One of the most important areas is menthol in
tobacco. And we have a rul e which is been out in draft form. We've got all the
comments and we hope to finalize that this year that will make it illegal.

And there's a very important [00:20:00] equity sort of double twist to this that
we have to all pay attention to. Menthol has b een marketed specifically to
African American people preferentially leading to higher rates of use and higher
rates of death and disability. But when we make it illegal, there's a risk that if we
don't handle this appropriately, it can bring law enforcemen t inappropriately to
the individual user and not to the manufacturer.

So we're [00:20:30] working hard anticipating this will be finalized to make sure
that the enforcement is against the manufacturer, not individuals in the
community. We're also dealing with flavors in cigars. Our youth are starting with
cigars almost as commonly as with combustible to regular cigarettes these days
or even more so.

And we have on the agenda the hope that we'll [00:21:00] be able to write a
proposed rule that will bring t he level of nicotine and tobacco products below
the addiction level. So it's an interesting question, how many people would use
tobacco products if they weren't addicted to nicotine? Then I think we may be
able to take care of that. So there's a lot coming . It's complicated and every step
is a battle with a bunch of really smart lawyers on the other side.

Mark Masselli: Commissioner, let me get in one last question. The president [00:21:30] is, and I
know something, it's important to you as well. The presid ent at Stanford
University's under fire for allegedly falsifying research data. And drug makers,
Amgen and Bayer have looked at this issue and they are finding it show as much
as 50% of all medical research cannot be reproduced due to flaws in research
qua lity. Is it that truly a broken system?

Dr. Robert Cali...: My answer to the last part of what you said [00:22:00] is no, I don't think it's a
broken system. But reproducing science has multiple dimensions to it. But if you

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ask me, is there room for a considerable improvement in the integrity of the
scientific enterprise for the reproduction of research before it's published to
make sure it can be reproduced?

Because some cases just slightly change the conditions under which the
experiment is done and you get a different answer. In other cases, [00:22:30]
there are temptations to take shortcuts and skip things or copy things over,
which are really bad. So yeah, I spent a good part of my academic life actually
working on these systems, mostly in clinical trials where blinding and the use of
double data entry and...

Mark Masselli: Right.

Dr. Robert Cali...: Audits and keeping track of where the data came from electronically is a really
important part of it. And I think these methods, which are very common
[00:23:00] in industry regulated applications to FDA, in other words, the
industry has much more rigorous standards in that regard.

The academia's been a little more free flowing, which is understandable in a
way because when it's discovery research, it's sort of self - correcting. But we can
do a lot better in terms of producing reproducible research. I've written a good
bit about this and would welcome people to look back at the things [00:23:30]
that I think about it. It's an important problem we should a ll pay attention to.

Margaret Flinte...: Commissioner Califf, we thank you for your service to our country. We hope
that you'll join us again in the future. And thanks to our audience for joining us.
There's more online about conversations on healthcare, i ncluding a way to sign
up for updates. The address is CHCradio.com. Commissioner, thank you so much
for taking the time to join us today.

Dr. Robert Cali...: Thank you. And I'm glad we could talk. Take care.

Mark Masselli: All right.

Margaret Flinte...: Th ank you.

Mark Masselli: Thank you so much.

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