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.