Jan 29, 2019
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"Welcome to this ASCO In Action podcast. This is ASCO's monthly podcast series where we explore policy and practice issues that impact oncologists, the entire cancer care delivery team, and the individuals we take care of, people with cancer. My name is Clifford Hudis, and I am the CEO of ASCO as well as the host of the ASCO In Action podcast series. For today's podcast, I am delighted to have as my guest Dr. Scott Gottlieb, the commissioner of the United States Food and Drug Administration.
The FDA of course plays a critical role in the delivery of high
quality cancer care by reviewing and approving cancer treatments.
This continues to generate discussions about the pace of scientific
advances, and indeed the regulatory role of the FDA. Given that, we
are really lucky to be able to talk today with Dr. Gottlieb about
the FDA's efforts to increase overall efficiency by updating or
modernizing aspects of our clinical trials conduct and expediting
the end to end drug development process.
I will admit that I'm going to take advantage of this opportunity
to also ask how his agency is tackling the issue of tobacco control
for the next generation of tobacco products, another area of deep
concern from our community and others. Dr. Gottlieb, welcome and
thank you for joining me today.
Thanks for having me here.
Great. Now as a professional society, we are very focused on the
intersection of science and society. Given that, and noting that
you've been at the FDA for more than a year following a long career
in public service and in private industry, I have to start by
asking, for you, has your current experience changed or evolved
your view of the FDA's role or functions, and if so, how.
I've been at the agency three previous times. I had a good sense of
what the agency's public health mandate was and what its mission
was. I think that the nature of the market and the science that
we're grappling with has certainly forced or compelled the agency's
mandate to evolve. I think what we're seeing right now is, I feel
like we're at the inflection point with respect to a lot of new
opportunities from technology.
We look at things like gene therapy and cell-based regenerative
medicine. Those fields largely didn't exist last time I was at the
agency, and now we're an inflection point where we're going to see
gene therapies approved to the market, and we saw three CAR-T's
approved already, that are going to fundamentally transform the
treatment of disease.
When I was last here, we were talking about the ability to advance
genomically derived drugs and have more targeted approach to the
treatment of patients where you can get the right drug to the right
patient at the right time with sort of a drug diagnostic system,
yet seeing some early examples of that. But now that is a much more
routine development pathway.
With respect even to tobacco, you mentioned tobacco at the
beginning, we're at a point right now where we have the opportunity
to use new technology potentially to help currently addicted adult
smokers transition away from combustible tobacco products onto
products that we presume don't have all the same risks associated
with them.
And so using new authorities we have to regulate tobacco, including regulate nicotine levels in combustible cigarettes to render them minimally and not addictive, and allowing for a regulatory pathway that puts some of the new technologies like e-cigarettes through an appropriate series of regulatory gates, we have the opportunity to transition adult smokers off of combustible tobacco with all their morbidity and mortality associated with combustible tobacco use more rapidly than we did in the past.
And so across the board, I think we're seeing technological inflection points. Digital health tools are another example that are not only creating significant new opportunities, but I think compelling the agency to rethink its traditional approach to regulation in order to accommodate the opportunities that these new technology platforms create.
So is it fair to sum all that up as, the agency is recognizing that technology in many domains is defining and driving the need for new regulatory frameworks, and in turn, we have to educate Congress and others to make sure that the agency actually has the appropriate authorities. Is that the virtuous cycle you're describing, you think?
I think that's exactly right. I think that there are areas of profound technological change where the traditional approach to regulation doesn't apply well. Digital health tools, probably a very obvious example where you can have sort of practical incentives, where you have a digital health tool, you might evolve it almost on a daily if not weekly basis in the marketplace. It's a medical product that's a digital health tool, like a medical lab, for example.
And a regulatory process that requires you to come in and file for premarket approval every time you want to make a modification or have to file a 510(k) supplement, that is antithetical to the rapid cycle of innovation and evolution that those kinds of products undergo.
So we had to think of a new regulatory paradigm for how we would treat these products, and that's where we move towards the Pre-Cert model, where effectively what we're doing is validating the underlying architecture of the platform, of the software platform, and validating the SOPs, how good is the company at certifying its own software and validating its own software products, and then we would allow them after an initial approval to come to market with modifications as well as subsequent approvals without having to seek premarket clearance from the FDA every time.
And we would shift toward the postmarket regulatory regime for subsequent products. So basically, instead of regulating the individual products, in essence we're regulating the firm and taking a firm based approach. That's an example of where we've had to rethink our regulatory model in order to accommodate a much different approach to innovation.
Another example is with cell-based regenerative medicine, where we have very clearly said that we think that there's a lot of opportunity with cell-based regenerative medicine, but we also see a lot of clinics promulgating products based on what we think is incomplete if not poor science and creating substantial risk of patients using cell-based products intrathecally, or for injections into the eye, where they're creating substantial risk and don't have really a scientific basis to argue that there's convincing evidence of a benefit.
And these products are clearly subject to FDA regulation. They
cross the line between what is and isn't regulated by FDA, but
subject to enforcement discretion of the agency over many, many
years. Prior to when I came in here, the agency didn't actively
regulate these products. We have said very clearly, we're going to
actively step in to regulate this field. In fact, it's going to
take a number of enforcement actions, and we'll be taking others.
At the same time, we also recognize that a lot of these
technologies are being promulgated by small developers, and there's
a lot of promise here.
And so we've had to again come up with a more accommodative
approach. But how do we regulate a field where a lot of the really
interesting innovations are being brought forward, for example, by
academic investigators working in small clinics. And so what we've
said in that case is that we'll allow investigators to pool their
data so long as they follow common manufacturing protocols that are
doing similar things with cells. And it can file a common BLA,
common Biologics License Application. And then we'll give
individual licenses to the individual institutions or individual
investigators.
That's a much different approach to regulation than what we've
traditionally done where you think of, we regulate companies, we
regulate a biotech or a pharmaceutical company. We had to ask
ourselves, how do we regulate small clinics or even institutions,
academic investigators in institutions, who want to promulgate
these technologies. And we've come up with an approach to do
that.
So at the same time that we've said we're going to be taking more enforcement action to make sure patients aren't being put under duress, we're also going to take a more accommodative approach to allow for regulatory approval for products that are being, in many cases, promulgated by smaller entities and individuals.
So that actually lets us pivot, I think, to an area of
traditional focus for at least a large group of our members at
ASCO. And that would be drug development. And it's clear that
you've made it a priority to streamline how new drugs specifically
are reviewed and approved.
And I think as part of that effort, recently you announced a new
office. It's the office of Drug Evaluation Science. And my
understanding is the goal is to centralize performance metrics like
biomarkers, patient reported outcomes. How do you see this new
office specifically helping to support this goal of a more
standardized and ultimately more efficient and faster review
process?
Well, the Office of Drug Development Science, the goal there is to
create an infrastructure here that will help better validate
scientific tools that are being used to help advance drug
development, like patient reported outcomes, like bioinformatics.
What we've seen is that these tools now, there's a lot of hard
science behind these tools. And they've become much more commonly
used in drug development programs.
And so we need an infrastructure here that not only provides for a
more standardized approach to assessing these modalities when
they're incorporated into applications, but also helping to advance
the science of how to use these tools. I compare it to what
happened in 2003 with modeling and simulation. And I was here
during the time period.
What we were seeing over that time period was we were seeing more
drug developers starting to use modeling and simulation as a
component of their overall drug development programs. And we saw
modeling being included in applications. Early on, it was often
used for dose finding because you wanted to give the dose finding
trials. But then you wanted to use the data that you derived from
the dose finding trials to simulate what would happen if you picked
a dose in between the two doses that you might have tested.
And so we said to ourselves, well, this is very interesting. This
could really help inform drug review better, give us more
information about safety and benefit. We need some standard
approach to how we're going to both evaluate these tools as well as
help develop them into a harder science so it could be more
rigorously used in drug development.
We created a Modeling and Simulation Office when I was here. Mark
McClellan was involved in doing it. He helped recruit the guy who
stood it up, him and Janet Woodcock. It was Larry Lesko. And it
started as a two-man office.
Now, we've got probably 30 or 40 people in the Modeling and
Simulation Group in Cedar. And well more than 95% of all
applications that we get for new drugs contain a component of
modeling and simulation. It's now a routine part of drug
development. And we have a rigorous approach to evaluating these
components of the applications as well as helping to evolve the
field through multiple guidance documents that we've put out.
I see the Drug Science Office, this new office that we created
within the Office of New Drugs, working in a similar way where it's
going to be a holding office, if you will, for new areas of science
that can help improve tools used to inform us about the risks and
benefits of new products.
So I want to pivot from that to one of the big societal issues. And
you and I have been discussing this informally, I think, for more
than a year-- drug price. The Trump administration has made it a
priority to address the cost of drugs, price specifically.
And I guess the question from many will be how confident can we be
that ultimately a faster and more effective drug development
process will itself actually and favorably impact the costs of
drugs. What's your feeling about that, knowing everything that
you're doing that's supportive in that way?
Well, I see my role in the drug price debate to be focused around
creating product competition. You have price competition. But you
can't price competition without product variety and product
competition. And we're focused on creating the product competition
by facilitating entry into the market of generic drugs, but also,
facilitating a pathway that allows for follow on innovation within
categories.
And what we've seen-- and we've analyzed this. We're going to be
publishing this data soon. But what we've seen over time is that
second to market innovation within a category is coming to market
much more slowly. We looked at a cohort of approvals from the early
2000s. And then we looked at a more recent cohort of approvals over
like a five-year period. And it's very clear that when you look at
areas of unmet medical needs, orphan drugs, first in class drugs
and oncologies, the second to market innovation is taking much
longer to come to market and more categories of drugs are remaining
sole source drugs in perpetuity.
So to the extent that you're not getting that second to market
innovation for new drugs, that is thwarting the opportunity for
price competition within those categories. Because you do see price
reductions. Oftentimes those price reductions come in the form of
rebates that aren't transparent to the consumer. But there are
price reductions or discounting nonetheless when you have a second
and third to market drug within a category.
And the hepatitis C category was the best example of that. We saw a
very dramatic price reductions in negotiations once you had
multiple entrants in that category. So we're focused on that. And
we're asking questions about why it's become harder to bring second
to market innovation to patients. And I think that there are some
very specific reasons and there's things we can do to help address
that, to make it less costly to bring second to market innovation
in an area of unmet medical need.
If the trials are onerous or very costly to bring that second to
market drug to the market, sometimes the economic opportunity might
not be robust enough after this one entrant, especially when you're
talking about very narrow niche categories of unmet medical need,
they're might not be enough economic opportunity to incentivize
that second to market innovation.
I think where-- just to sort of close, I think where this might be
most evident is in some of these inherited diseases. You've seen
this play out in gene therapy, for example, where once you come to
market with a treatment and you treat the prevalent population, the
people who already have the disease, the incidence population, the
number of people who are going to get it on an annualized basis,
that might not be a big enough market to support a second entrant
that's going to split the market with the first in class
product.
And so I am quite literally seeing investors pull out of these
opportunities which we see what we think are applications being
slowed down. We see people pull out if they think they're going to
be third to market. And that's ultimately bad for patients. Because
it's not just robbing patients of product competition, but it's
also robbing them of potential product variety. And we know not
every patient responds to a treatment the same way. So you want
differentiation in the market.
And also if there's a horse race between being first, second, third
to market and the third to market pulls out because they don't
think they're going to be first or second, sometimes the first or
second doesn't pan out. And then you're stuck with nothing. So this
is not a healthy development. And if there's things we can do to
make the development process more efficient to create more
entrants, that's something we're focused on.
So that's great. You raised at least two issues that I want to
pursue a little further. Let's start with the first one, which is
technology based. Recently you announced specific plans to keep
pace with the influx of applications for selling gene therapies.
And you've referred to that already in your comments.
But you've raised concerns specifically around, I think, if I
understand it, reimbursement environment for CAR-T therapies and a
fear that that reimbursement challenge may, in fact, stifle
innovation that's needed. Is there more to say about that? Or is
that pretty much the issue right there?
Well, I think that that's one of the issues. I think the issue,
obviously, is-- and many people who are in this space are acutely
aware of this-- is that there's different pay structures on the
inpatient and the outpatient side to the extent that some of these
products are being labeled for use in inpatient only. The
reimbursement on the inpatient side is much lower and more
difficult than reimbursement on the outpatient side right now.
So that's an unusual situation and something that's artificial. I
mean, a drug shouldn't be reimbursed diametrically differently just
because it's delivered in one setting versus another and the reason
why you're pushing it into an inpatient setting is for safety
considerations. And so I think it's something we need to address.
We can't allow that sort of artificial differentiation to
persist.
There's a lot of late stage CAR-T development. But we're not seeing
a lot of early stage CAR-T development. And if you talk to people
in the field, they'll say, well, it's because CAR-T hasn't
demonstrated its ability to really potentially be effective in
solid tumors. And a lot of the liquid tumor opportunities are
already being pursued.
I'm not sure that's true. I think that there is a reluctance. At
least part of it is a reluctance to make significant investments
right now because the reimbursement environment is so uncertain for
these products. So that ultimately needs to be resolved by others,
including CMS. But I think that there are things we can do as well
here at FDA.
So for example, we say that a product should be labeled for
inpatient use because we believe that with certain risks associated
with the delivery of some of these products-- and you're very
familiar with those risks and so are all your listeners-- require
the ability to deliver intensive care or significant medical
services if a patient does have a reaction on an infusion of this
product. But that doesn't necessarily mean that you need to be in
an inpatient facility.
What it means is you need to have within a reasonable period of
time-- and you can define that period of time-- access to
significant supportive care. I know institutions where the
inpatient infusion center is further away from the medical
intensive care unit than the outpatient infusion center. So that
makes no sense. Why would you say it has to be in an inpatient
setting when the inpatient setting actually is further away from
the kinds of medical resources that we want accessible to the
patient?
So really what we should be considering is defining and labeling
the kinds of services that need to be available within a certain
period of time, and not necessarily inpatient or outpatient.
Because there are a lot of outpatient infusion centers that are
adjacent to academic institutions where you can have a significant
amount of supportive care delivered very quickly. And the patient
is very accessible to a medical intensive care unit if they do have
an adverse reaction.
So we're rethinking that, how we label these products. But that's
a-- it might solve the proximate challenge. But ultimately, I think
you need a fundamental solution to the pay structure so there's not
an artificial divide between the inpatient and the outpatient with
respect to these products.
So just in the interest of time, I want to make sure we cover the
monetization of clinical trials because that's the other issue, I
think, rightly raised. And you've for a while made this a priority,
I know. And I'll just jump ahead and say, and I think if I remember
correctly, your agency the FDA issued two draft guidance documents
on innovative trial design within the last year.
The first focused on master protocols. And the second on specific
advice in terms of design and conduct for adaptive trial designs.
That's a compressing approach in terms of the phases of traditional
studies. Can you talk a little bit about why this is important and
what kind of savings you think this could actually deliver as a
practical matter?
I think it's important because, first of all, I think a lot of the
drugs that are being put into development can't be developed
efficiently with the traditional approaches to drug development. So
for example, you think of a drug where it's targeting molecular
change that's apparent in multiple disease states. This is most
obvious in cancer where you have tissue agnostic approvals where
you might want to do a basket trial where you test a drug in
multiple tumor types where what's driving the tumor is the same
genetic alteration, molecular change.
And you want to be able demonstrate that it works across multiple
tumor types, especially with rare tumors where you might not-- if
you said, well, you have to prove it first in lung cancer and then
you go on and prove it in liver cancer. But it might be such a rare
genetic change that you're not going to be able to efficiently
enroll just in lung cancer and liver cancer. So you want to pool
the data across multiple tumor types to demonstrate statistically
significant evidence of benefit.
I think because more drugs are being designed that way, we have to
rethink how we allow sponsors to conduct clinical trials,
structured clinical trials. And so things like basket trials and
master protocols and tissue agnostic approvals become very
important in this paradigm.
It also can allow for a lot more efficiency. A master protocol can
allow you to test multiple drugs within the context of the same
trial. If you have a situation where you're looking at targeting a
rare disease or a rare subpopulation of a disease, where it's hard
to recruit people, if you have a master protocol set up, you can
test multiple drugs in the same population much more
efficiently.
So as we develop drugs that are targeting smaller and smaller
populations and delivering, in many cases, outsized benefit and
demonstrating earlier evidence of benefit, we need to rethink how
we structure trials to take advantage of those opportunities. I
think one of the-- we approved a record number of novel drugs this
year by a long margin, 59 approvals. The second best year, which
was last year, in modern times, I think was 46. We approved 19 new
NDA and BLA products focused on cancer and had 38 supplements this
year.
If I was to point to one thing that's driving that innovation, it's
the fact that more of the drugs, many more of the drugs that are
being put into development now not only have a very plausible
biologic rationale for why they're going to deliver benefits, but
they're so well targeted, so the underlying disease state is so
well understood, that we're seeing much more significant benefit
much earlier in drug development in much more compelling disease
situations.
And so, proof of concept is established very early. And you can
establish statistically significant evidence of benefit in a very
small series. And that's accelerating these products through
development. And more of these cases are situations where you're
targeting such significant unmet medical needs that even if there
is uncertainty around the full scope of the safety profile, the
outsized benefit in that clinical setting overwhelms any of that
uncertainty.
And so you can move these products through development much more
efficiently. That's the nature of the science that we're seeing
right now. And I think it's going to be the way we see the field
move forward, at least for the foreseeable future.
You know, one of the issues that this raises is the issue of
targeting and niche subpopulations which you've referred to. We've
tried to deal with this within ASCO by launching TAPUR, which takes
next gen sequencing, by and large, and matches patients who are
theoretically scientifically appropriate for off label use with
drugs that are in the market but where the indication doesn't
include their histology. And I know your agency is familiar with
it.
But that, in turn, generates prospective evidence. The vast
majority of patients, as you know, in the United States simply
don't have the opportunity for various reasons to participate in
clinical research. And that has raised questions about the utility
of so-called real world evidence and real world data.
You know that the FDA has been working closely with ASCO,
especially with our big data project CancerLinQ, so that your
agency has access to our growing big data repository. And that in
turn, we all hope, will inform certain aspects of regulatory
review, I guess mostly in the area of label extensions.
So your agency recently released a framework providing detail on
how the FDA is going to develop guidance for real world data in
drug regulation. And we're especially excited by this. We're
invested in this, in a sense. And we look forward to working on it
as it rolls out.
How do you see this framework being implemented specifically? How
is it going to benefit patients?
I think it's going to address one of the things you said right up
at the top, which is patients don't have access to clinical trials.
I think as we make more rigorous use of real world evidence in the
development process and in the regulatory review process, that's
hopefully going to open up the opportunity for data collection and
clinical trials to move out into the community.
Real world evidence isn't just evidence collected after the fact.
You can have real world evidence collected in randomized settings.
You can have real world evidence collected in prospective settings
where you have large, simple registries and other kinds of
constructs.
And so, as we're able to make more rigorous use of these kinds of
data constructs, I think it's going to push clinical data
collection further out into the community so more patients are
going to be able to access experimental protocols where the
evidence is being generated that's going to help inform regulatory
review, either in the pre- or post-market setting.
And we're clearly making widespread use of real world evidence in
post market setting, particularly for confirmatory studies post
approval. And you're seeing situations where it's also informing
decisions on the premarket side as well.
So I guess, since we're talking about access, one has to at least
address the question of very ill patients and access to
investigational drugs outside of the clinical trial system, what's
been called expanded access. And this has been a topic of great
discussion and debate for the last couple of years. Can you talk
about some of the specific changes that the agency is making and
how you see this helping patients and physicians navigate the new
expanded access program?
Well, the one that we announced recently is that we're going to
create a service here at FDA where we're going to staff it.
Initially it's going to be sort of a pilot. And we'll focus it on
oncology where we'll help patients navigate the expanded access
process soup to nuts where effectively they will be able-- if
someone identifies an expanded access protocol that they want to
get entry into with their physician, their physician is going to be
able to call FDA. And FDA is going to help guide them through the
process, soup to nuts. FDA will have people who will make the
outreach to the sponsor and do the interface with the patient and
provider to make sure the documentation is done in a timely
fashion.
This is also going to have the advantage of allowing us to be on
the phone with the drug sponsor to understand why drug sponsors
might not give access in certain settings. And so what we find is,
in some cases, we're willing, we approve the ability for a patient
to get access to a product, but the drug sponsor might turn it
down. And so this is going to allow us to collect more information
about why it might be turned down.
It's also going to allow us to identify situations where there
might be a lot of requests of one drug company so that we can
intervene to help encourage the development of a true expanded
access protocol. If there's a lot of compassionate use requests,
for example, of a single sponsor or a single drug, those are
situations we might pick up the phone and say, hey, we're approving
or we're getting requests for a lot of compassionate use. Why don't
you think of starting an expanded access protocol? We can work with
you on that.
So I think that having FDA be an interface there is not only going
to make it more efficient for the patient and provider to access
the system, but hopefully will also allow us to interface better
with sponsors to sort of create the conditions where drugs can be
made more widely available under appropriate conditions.
And just for clarity, I assume that there is a 800 number or web
URL for that. Is that right?
Well, we stand it up. It's still in process. So it's something that
we're going to do soon. But yeah, this will be widely disseminated
to folks.
Great. So the last thing I want to talk about, which brings us in
some ways back to our roots, is tobacco. And I said at the top of
this that we would touch on this. This is an area where our field
saw slow but ultimately critical progress starting in the
1960s.
And all of this feels like it might be jeopardized by a recent and
alarming uptick in tobacco use in children, essentially kids and
young adults. And this is just setting off, as I say, alarm bells
across our field. I think there's data from the FDA and the CDC
that in 2018, 3.6 million students were e-cigarette users. And this
was compared to just 1.5 million about a year earlier.
Now there's still not a lot of research on Electronic Nicotine
Delivery Systems or so-called ENDS. But there is at least some
reason to believe that they might increase the likelihood of
nonsmokers or former smokers converting to combustible tobacco with
their known risks.
So last year, I know that the agency announced the Youth Tobacco
Prevention Plan to address this alarming trend. And it'd be great
if you could talk a little bit about the plan and what you intend
to do and update it, as I know you've been talking at least on
social media about this issue in particular.
Well, we think that the non-combustible products like e-cigarettes
provide a potential opportunity for currently addicted adult
smokers to transition off of combustible tobacco onto modified risk
products. These products, the e-cigarettes, need to be put through
an appropriate series of regulatory gates. But I've said many
times, if we can transition every adult smoker off of cigarettes,
traditional cigarettes, onto e-cigarettes, that's going to provide
a significant public health advantage, public health
opportunity.
The e-cigarettes are certainly not risk free. Those risks need to
be properly defined through a regulatory process. But there is an
opportunity there. And what we announced early on last summer of
2017 was that we are seeking to-- and we've advanced the rulemaking
to do this. We're seeking to regulate nicotine levels in
combustible cigarettes to render them minimally and not addictive
so they can no longer sustain addiction.
At the same time, we allow the e-cigarettes to remain on the market
while we put them through an appropriate series of regulatory gates
with the notion being that if regular cigarettes no longer have
nicotine, smokers would more rapidly migrate off of traditional
cigarettes, hopefully off of nicotine altogether. But if not off of
nicotine, onto either medicinal nicotine products, the safest form
of nicotine delivery. Or if they want inhaled forms of nicotine
delivery, onto e-cigarettes.
Again, recognizing that e-cigarettes aren't risk free. But on a
risk continuum, nicotine exists on a risk continuum, they are lower
risk than combustible tobacco. But what I said all along was that
that opportunity and that policy framework couldn't come at the
expense of addicting a whole generation of young kids onto nicotine
through these same products. And that's, in fact, what we're
seeing.
We are seeing an epidemic growth. And this is what we spoke to last
fall in the use of e-cigarettes by children with fully a 78% rise
among high school aged kids in e-cigarettes in over one year, from
2017 to 2018. And really no indication that it's going to abate
very quickly in the coming year.
So what we set out to do was implement a series of regulatory steps
to try to address the access and appeal that these products have to
kids. So we are putting in place significantly heightened age
verification requirements for the purchase of products in
convenience stores. We're particularly targeting the flavored
products because we think the flavored products are a primary
vehicle by which these products are appealing to children.
At the same time, we launched a series of public education
campaigns that we think are very effective to try to educate youth
about the risks of e-cigarettes. But I'll say in conclusion that if
these actions don't have a very immediate effect on these trends--
and you're not going to reverse these trends overnight. These
trends are underway. This has become sort of a fashionable item
among kids. You're not going to just reverse that overnight.
But if we don't see this growth leveling off and starting to
reverse, I think that this is an existential threat for the entire
e-cigarette industry. You know, I find myself stuck in
conversations where I'm debating with them the merits of selling
cherry flavored e-cigarettes at convenience stores or gas stations
where it's readily accessible to a kid. And I think what they
really should be contemplating is, boy, if these trends go up
another year, my entire product's going to be taken off the
market.
Because that is the cold, hard reality. We are going to-- whether
it's FDA acting to change its enforcement policy or it's Congress
stepping in, if you see another year of 50%, 60% growth in
e-cigarette use among minors and you see fully 45% of American kids
using some form of tobacco products and you see combustible smoking
rates trying to go back up again, that's going to be a public
health catastrophe. Nobody is going to have patience to tolerate
that for another second. And there is going to be dramatic steps
taken.
And so I think that the industry ought to wake up to that fact.
We've certainly woken up to that fact and recognized it. And it
would be a shame. It would be a shame because the e-cigarettes do
represent an opportunity for currently addicted adult smokers in a
properly regulated market. We don't want to foreclose that
opportunity entirely. And we don't want to impede adults
unnecessarily from getting access to these products.
But we are not-- collectively, we haven't done all we can and all
we should to address the youth use. You're going to see us take
more steps going into this year. We have more enforcement activity
underway. But the manufacturers also need to stop fighting some of
these steps. And they need to start addressing this more seriously.
And, you know, it's one big manufacturer in particular that's
driving a lot of the youth initiation on these products.
Well, it's great to hear the vigor that is being brought to bear on
this. And I know that in our community there's tremendous support
for threading this needle just right, as you describe. So thank you
for that.
I want to just take a moment now and say, in general, to Dr.
Gottlieb, thanks for joining me today for this ASCO In Action
podcast. We are really grateful at ASCO for the strong
collaboration that exists between us, the entire oncology
community, and the FDA. And we look forward to continuing our work
together to make sure that patients with cancer have access to safe
and ever more effective treatments.
As a reminder to listeners, you can follow Dr. Gottlieb on Twitter
@sgottliebfda. That's one word. You can follow me, a little less
exciting I think, @cliffordhudis. And you can follow ASCO @asco. To
stay connected with the latest updates on the FDA's work, visit
fda.gov.
And as always, we will continue to provide here updates on relevant
FDA activities at asco.org/ascoaction. Until next time, thanks
again to Dr. Gottlieb and thanks to all of you for listening to
this ASCO In Action podcast.