Good morning.
It is a pleasure to be with all of you – albeit virtually – for this Public Meeting on the
reauthorization of the Medical Device User Fee Amendments (MDUFA).
MDUFA plays an important role in helping the FDA meet the demands of our increasingly complex
and diverse mission at home and abroad.
The breadth of those demands grows more expansive all the time, both as a result of new responsibilities
placed on the FDA and by advances in science and technology.
This year, those demands have risen to unprecedented levels, not because of any new authorities
given to us, but because of the FDA’s vital role in responding to the COVID-19 public
health emergency.
So, before I turn to the specifics of this important reauthorization, I want to say a
few words about the more than 17,000 FDA employees, who every day bring extraordinary professionalism,
knowledge, and commitment to their jobs and the agency’s mission.
Like so many Americans across the country, eight months ago the FDA staff had their worlds
turned upside down by COVID-19.
Since then, they have faced significant challenges -- both in the workplace, including working
in a virtual environment -- and in the personal arena, whether juggling at-home child or elder-care
responsibilities, or simply managing the fear and anxiety the pandemic is imposing on our
families, friends, and communities.
Remarkably, the pandemic did not stop or even slow FDA’s pace of work; it actually accelerated
it, with our workload essentially doubling, and our workforce immersed in a round-the-clock
response to COVID-19.
Incredibly, this remarkable effort has taken place as our centers and offices have continued
to fulfill the Agency’s regular mission-critical responsibilities, from the approval and clearance
of medical devices, to the approval of safe and effective new drugs and biological products,
to maintaining our high standards of food safety, and ensuring our continuing oversight
of tobacco products, including e-cigarettes, to name just a few areas.
Of course, COVID-19 continues to be a primary focus.
I’m so proud of the employees in all of our medical product centers, who have addressed
and solved problems involving some of the most challenging public health issues we’ve
faced in over a century, including supporting the development of therapeutics and vaccines.
Our teams in the Centers for Devices and Radiological Health and Biologic Evaluation and Research
have done an extraordinary job helping to ensure the availability of essential medical
devices to respond to the pandemic.
Starting back in January, they’ve facilitated alternative testing strategies to address
supply shortages, worked to augment increases in personal protective equipment, ventilators,
and other essential medical devices, ensure continued access to necessary medical products,
and address the sale of fraudulent products.
And, at an incredibly fast pace, they’ve reviewed and issued emergency use authorizations
for medical devices for COVID-19.
Since the beginning of February, CDRH has received more than 5,000 requests for EUAs
and pre-EUAs.
We have authorized the emergency use of over 550 medical devices, including more than 280
tests—a rate of review that amounts to authorizing, on average, one test every single day.
One way we’ve accomplished that is by working closely with developers.
For example, in January, the agency had begun engaging with commercial manufacturers of
diagnostic test kits and laboratories.
to streamline submissions and help foster accurate test development and validation.
The agency developed an EUA template with recommendations on validating a molecular
diagnostic test for SARS-CoV-2 and outlined the required information.
By July 31, the FDA had authorized 163 Covid-19 diagnostic tests.”
We also continue to rapidly adapt our policies to meet evolving circumstances.
The FDA has issued more than 60 guidances so far — including more than 20 specific
to medical devices—that provide targeted regulatory flexibilities to respond to the
pandemic.
In developing these policies, we considered what was needed to address COVID-19 specifically—for
instance, policies designed to expand the supply of diagnostic tests, ventilators, infusion
pumps, and personal protective equipment.
But we also thought about what was needed to respond to the collateral effects of the
pandemic, such as the need for technologies to help protect patients and providers from
exposure to COVID-19 by better enabling social distancing measures and to facilitate the
ability of patients to receive their health care remotely.
We issued policies for medical imaging equipment, remote monitoring devices, and ophthalmic
and other devices.
We provided regulatory flexibility for certain changes designed to enhance the functionality
of these devices under the circumstances caused by the pandemic and made adjunctive digital
health therapeutics for psychiatric conditions more readily available.
It has been an extraordinary response by the entire FDA workforce – demonstrating professionalism,
knowledge, and dedication to public health.
I want to underscore two important points in this regard.
First, in all the work done in response to the pandemic, we at the FDA have maintained
our focus on applying rigorous science and the best available data to any policies being
developed and any decisions made, no matter how quickly.
And second, which I already mentioned briefly, is that we have continued to fulfill our regular
responsibilities, even as we have worked to respond to the pandemic.
Those two points are important as we consider the subject of today’s meeting -- how the
FDA has continued to work hard to meet our performance goals and other commitments under
the current MDUFA agreement.
The FDA’s User Fee programs help us fulfill our mission to protect public health while
also helping to accelerate innovation and bring new treatment options to the American
public.
Despite the pandemic, non-COVID submissions have not decreased.
Remarkably, in the first eight months of 2020, which included the height of the COVID pandemic
response, the numbers of Original Premarket Applications, De Novos, and 510(k)s, under
review all exceeded the numbers from a year ago.
We continue to perform our user fee review activities for these non-COVID therapies and
diagnostics, and this year we approved or authorized several novel devices, including
three aimed at improving the health and well-being of children.
These include a first-of-its-kind automated insulin delivery and monitoring system for
use in pediatric patients aged 2 to 6 years old.
It is the first legally marketed device that can automatically adjust insulin delivery
based on continuous glucose monitor values for this patient population.
We also granted marketing authorization (through the de novo pathway) to the first game-based
digital therapeutic device to improve attention function in children ages 8 to 12 years old
with attention deficit hyperactivity disorder.
This was the first digital therapeutic intended to improve symptoms associated with ADHD,
as well as the first game-based therapeutic granted marketing authorization by the FDA
for any type of condition.
And we granted marketing authorization to a new device indicated to provide continuous
hemodialysis or hemofiltration therapy to certain critically ill pediatric patients.
It was the first continuous renal replacement therapy device intended for a lower weight-specific
pediatric patient population who have a sudden or temporary loss of kidney function or too
much water in their bodies because their kidneys are not functioning properly.
We have also continued to advance other important initiatives, such as launching the Digital
Health Center of Excellence, which will focus on aligning digital health efforts and act
as a hub for regulatory innovation.
And we continue to take strong measures to address device safety concerns, working to
deliver on our vision of being consistently first among the world’s regulatory agencies
to identify and act upon device safety signals.
To that end, our efforts to build a robust device patient safety net in the United States
are continuing.
Through the National Evaluation System for health Technology Coordinating Center (or
NEST), we’ve embarked on a potentially transformative public-private partnership to perform active
surveillance; perform timely, efficient post-market safety studies; and develop, test, and apply
new methods to detect and evaluate for enhanced safety signals.
We have also continued to act in specific cases, when new information emerges about
the potential risks of any device.
I encourage you all to review the video series prepared by CDRH that highlights the significant
progress the Center has made to date with implementing and going beyond the MDUFA IV
commitments.
As we enter the next cycle of MDUFA negotiations, it is imperative that we continue to build
on the successes of the past few years, and to look for opportunities that enable us to
work smarter.
As a starting point, we must acknowledge the significant strain that the response to the
COVID-19 pandemic is having on our ability to continue to meet user fee goals, as well
as the toll it is taking on FDA staff.
It is no exaggeration to say that the work I’ve witnessed from my colleagues over the
past eight months has been nothing short of heroic.
But it is also a level of effort that cannot be sustained in perpetuity.
Even absent the COVID pandemic, the FDA’s medical device team was already operating
at a breakneck pace.
The MDUFA IV agreement set ambitious review performance goals, and it included a host
of infrastructure and process improvement commitments that the Center has worked tirelessly
to meet.
Yet the size of the device user fee program, and the resources that come with it, are only
a fraction of the size of the programs for prescription and generic drug user fees.
This makes the program’s success all the more remarkable.
However, it also causes me concern for the long term health of the program and its ability
to both protect and promote public health, particularly in light of the ever accelerating
pace of device innovation.
It should also cause us to pause and reflect on what we can achieve through MDUFA reauthorization.
Today’s public meeting is an opportunity to begin a dialogue about how FDA and industry
can collaborate to work both hard and smart to achieve our mutual goal of supporting timely
patient access to safe and effective medical devices.
It also provides the occasion to hear from other stakeholders on what the medical device
user fee program should accomplish during MDUFA V and how we can achieve it.
This is a chance, for instance, to see what investments we can make in human resources
and programs that enhance opportunities for meaningful early and ongoing communication
between FDA and device sponsors.
As demonstrated by the Breakthrough Devices program, if structured well, such interactive
programs help bring safe and effective devices to patients more quickly than standard premarket
reviews.
It’s also an opportunity to consider, for instance, what further investments can be
made in the development and evaluation of real world data from patient registries, electronic
health records, and other sources.
Evaluation of real world data has the potential to provide a wealth of rapid, actionable information
to better understand device performance and safety under a variety of use conditions.
And the enhanced understanding from real world data can, in turn, spur advances in product
development and help to inform clinical and public health decision-making that pays dividends
for patients, industry, FDA and our society as a whole.
Finally, it’s an opportunity to consider how we can provide technological, programmatic,
and other resources to the device team – resources that enable the FDA to build a program that
can continue to sustain its success by investing in our most important resource—our people—throughout
the next MDUFA cycle and for years to come.
In conclusion, today’s meeting offers the opportunity to examine the best ways to accomplish
these goals.
I can assure you that whatever changes are put in place, the FDA’s decisions will always
be driven by facts and data, and made by FDA’s expert scientists, with scientific rigor,
integrity, and the public interest at the center.
Thank you.