Thank you for the invitation to be here today.
I am honored to represent the United States
Food and Drug Administration and our new commissioner,
Dr. Scott Gottlieb.
As many of you may know, our new Commissioner
arrived at the agency just five weeks ago
and we’re learning about his vision and
how we can help execute that vision.
It is also my pleasure to be on an international
panel here and to talk about and reemphasize
our commitment to international collaboration.
I’ll talk about that in a bit, but 
what I’d like to do now is set the stage
and describe to you what it has been like
at FDA for the past five weeks and what we
can learn about the Commissioner’s priorities.
Then, I’ll briefly outline one of the successes
that we have achieved since the new Administration
arrived at FDA.
That success is the finalization of the Mutual
Recognition Agreement between the EU and U.S.
FDA with respect to GMP inspections for drug
facilities.
Let me start by explaining what it has been
like for the past five weeks.
I can tell you we have an active and innovative
new Commissioner.
With the arrival of Commissioner Gottlieb
has come fresh thinking and the possibility
of new and different types of collaborations
that will lead us toward enhanced scientific
development and the use of the law.
If both converge, it will allow us to regulate
more efficiently.
Commissioner Gottlieb’s has laid out his
domestic agenda and number one on that list
is to do everything the FDA can do to stem
the opioid abuse epidemic in the United States.
I would add that we welcome the opportunity
to speak to other regulators about a problem
that has been plaguing the United States for
many years.
The Commissioner has already taken 
a step in his first five weeks to creatively
address the problem.
He recommended that a manufacturer take a
particular opioid product off the market given
the high risk of abuse.
Based upon scientific evidence, he made this
recommendation because the risk benefit analysis
for this particular drug has changed and the
abuse potential has increased.
It’s this type of new thinking and harnessing
all of FDA’s scientific and legal authorities
that, I believe, is a sign of things to come.
He has also set up a commission to think of
new ways to confront opioid abuse.
The other example I will give from Commissioner
Gottlieb’s brief tenure is his emphasis
on drug pricing, which I know is an issue
that affects all the regulators here and all
countries around the world.
Traditionally, FDA has not been seen as an
active participant in the debate over drug
pricing.
However, Commissioner Gottlieb very early
on, in testimony to the U.S. Congress and
in written notes to FDA staff, has stated
that he wants the FDA to intervene because
he - and the Administration – views drug
pricing as a high priority issue.
What he has talked about in the drug-pricing
arena is the need for a certain number of
generics to be on the market so that competitive
forces will result in a reduction of prices
to American consumers.
In addition, he is working to focus even more
effectively on reducing the generic approval
backlog at the agency.
Moreover, he has said, on the innovator side,
that it is critical to get better therapies
for the most serious diseases.
When we have innovative therapies, the overall
cost of healthcare may be reduced.
I believe this high-energy approach to new
and old problems will also be seen in his
approach to new technology.
Dr. Gottlieb has a background as a doctor,
as a patient, and as a participant in both
public and private industry.
As such, he brings a vantage point to new
technology that will hopefully be collaborative
with all of our partners to ensure an even
more efficient and effective public health
future.
He has already developed guidance documents
on how the FDA is going to begin thinking
about and regulating new technology – such
as health apps and new combination products
- and we can expect him to take carefully
considered actions after consulting with a
wide range of experts across the FDA and around
the world.
I will also note that he is a very approachable
Commissioner; you can see him on the FDA campus
having lunch in the cafeteria with employees,
and he values input from a wide range of people.
Dr. Gottlieb has also spent time concentrating
on strategies to reduce the number of counterfeit
drugs entering the US market, particularly
those that are coming spiked with fentanyl,
which contributes to the opioid abuse epidemic.
He has talked to many people across the agency
about how we can we deal with counterfeit
drugs, which is one that has plagued many
countries around the world.
Now, while it is difficult to ascertain all
of the future endeavours of Commissioner Gottlieb,
I know he is very focused on making regulatory
work innovative.
Those of us involved in public health hear
all the time about how inefficient we are
and how we stifle innovation.
Every FDA Commissioner tries very hard to
battle that stereotype and Commissioner Gottlieb
will continue that battle.
However, I know that he expects our regulatory
agencies to work hard in this area, and one
way of being innovative is to have an understanding
of evolving technology.
What is needed at FDA and all of our regulatory
agencies - and Commissioner Gottlieb has already
testified twice to the U.S. Congress about
this regarding his 2018 budget plan - are
employees who are bright, creative, forward
thinking, and intellectually honest.
These kinds of individuals will help the agency
move into the future and as Dr. Gottlieb noted,
critical to that goal is maintaining an FDA
budget that will ensure those types of people
remain in, and join, the agency.
As well in his Congressional testimony, Commissioner
Gottlieb emphasized his innovation agenda.
In fact, just yesterday, he committed to reducing
the orphan drug backlog in the next 90 days.
This is a significant commitment to innovation
and to treating diseases that have not previously
had any treatment, and it underscores that
we can expect this type of inspired action
going forward.
As I was walking around the DIA seminars yesterday,
I was struck by the number of sessions that
focus on different ways to approach clinical
data usage and clinical trial design, as well
as the use of real world data and real world
evidence.
That is now a legal requirement in the United
States that we begin to use and really harness
the power in real world evidence and in new
and innovative clinical trial designs.
We will be doing that under our new legal
authorities.
We now have a new legal mandate to engage
with patients even more than we have in the
past.
We’ve followed very closely the efforts
of other regulators to wade in and embrace
the idea of using patients to assist in driving
scientific development and innovations.
I can assure you that FDA will remain committed
to developing international standards that
benefit all of us globally.
We need to engage on issues like the ethical
design of clinical trials and the protection
of human subjects.
We need to engage on obtaining high quality
safety data and we need to continue our work
on quality manufacturing and GMPs.
As I have noted, during the last five weeks,
Commissioner Gottlieb has begun to define
his domestic agenda and I think we can expect,
in the weeks to come, more definition of his
international agenda.
He has emphasized to me twice his desire to
expand his reach into international areas
in ways that complement his domestic goals.
As all of us on this panel and in the audience
know, we all rise together through partnerships,
both scientifically and legally.
One of the best examples of this in recent
months is the conclusion of negotiations for
the U.S. / European Union Mutual Recognition
Agreement (MRA) that covers drug GMP inspections.
The MRA is a very significant achievement.
Indeed, the FDA has never implemented an agreement
like this before.
The FDA and EU officials spent the last three
years negotiating this agreement.
It is complex because there are 28 countries
and 28 separate inspectorates in the European
Union.
Each needs to be independently assessed by
the FDA.
We worked very diligently to create an assessment
process that makes sense and that is efficient
- and one that will be easily defended at
the end of the process.
We at FDA benefited from this sometimes painstaking
but always valuable assessment process.
As I said yesterday to our Japanese colleagues:
It really makes a difference to actually go
and spend time in other countries.
On that note, I had the benefit of leading
the FDA Europe office for almost three years
and I can personally confirm that there isn’t
any better to truly understand a foreign culture
than by immersing yourself in it.
As part of the exercise of evaluating countries
in the EU, officials from across the FDA have
visited - and will visit - every country in
the EU.
Many of our people have never been to those
countries before.
These visits are truly a way to breakdown
stereotypes, to build partnerships, and to
understand how different regulatory systems
work.
This is the central vision of the U.S. FDA:
Bring together science, law, and regulations
- and harness those for the benefit of overall
public health.
I know I speak for Commissioner Gottlieb when
I say that we look forward to new collaborations,
strengthening old collaborations and moving
forward into a new era at the U.S Food and
Drug Administration.
Thank you.
