Remarks by Acting Commissioner Dr. Ned Sharpless -- First All Hands Meeting April 15, 2019

Speech | In Person

• Speech by: Norman E. "Ned" Sharpless, MD ; Acting Commissioner of Food and Drugs - Food and Drug Administration

(Remarks as prepared for delivery)

Thank you, Lauren and Keagan.  And my thanks to the rest of the team in the Office of the Commissioner who have helped me survive my first week at FDA.

I also want to thank the President for having the confidence in me to take on this new role, and Commissioner Gottlieb and Secretary Azar for their strong support and guidance during the transition.

Importantly, I want to acknowledge the wonderful workforce of the Food and Drug Administration. I’m delighted to see so many of you here today at White Oak, and I look forward to meeting many of you in the coming months. 

I also want to recognize the many investigators, special agents, compliance officers, researchers, public affairs specialists and other staff located in our field offices and laboratories who are watching online.

All of you capably represent FDA and play a pivotal role working from our posts around the globe in support of our essential mission to protect the health of the American public.  

With an agency of this size and so many employees who work from different sites (and in different time zones), internal communication can be a challenge.

To strengthen efforts in this area, I plan to get out in the field.  I hope to visit with many of you in our field offices and see first-hand what you do.

My Background

It is an honor – and a humbling experience -- to be selected as Acting Commissioner of the Food and Drug Administration.  I know what a special and historic place this is, and I am excited to be a part of the team.

As you may know, I’ve been the director of the National Cancer Institute at NIH since 2017.  Before that, I was a cancer researcher and cancer doctor, treating patients with hematologic malignancies, for nearly 20 years in academia.

During that time, I ran a successful NIH-funded lab studying the molecular mechanisms of cancer and aging, and I also was director of a large Comprehensive Cancer Center.

Some of the work from my lab was highly translational, leading to significant experience with biotech and pharma development.  I’ve been involved in helping patients through the clinical development of novel diagnostics, small molecules, biologics, and medical countermeasures.

As NCI Director, I repeatedly spoke about how the present is such an exciting time to be a cancer researcher, because the pace of progress against cancer in recent years has been so remarkable.

And anyone who has been a part of that effort is highly aware that the FDA has played a key role in this rapid progress.

So I am well aware of how important the work of the FDA has been in cancer, and it is now thrilling to come to the FDA in order to work beyond cancer, to advance our public health mission across the entire spectrum of human and veterinary medicine.

Initial Impressions

Although I’ve only been on the job a short while, this place has already made some big impressions, a few of which I thought I’d share.

First, I’ve been impressed by the talent and diversity of the people who work here.  The thousands of employees who make up FDA’s dedicated professional workforce offer a remarkable mix of expertise and backgrounds.

Let me provide an illustrative example, working in academia and biotech, I have seen that there are not enough women in leadership positions in the sciences.  That’s clearly not the case here at FDA, where the agency boasts a number of strong, smart women leading some of the most important parts of the agency.

In my mom’s medical school class (UNC class of 1959) there were only two women out of 60 students. So you can see I have had a personal interest in how female doctors balance life and work since I was an infant, and throughout my career I have been interested in the challenges for working women in science and medicine.

This is an area where I hope the lead the FDA in further progress, but I can say that already I believe the FDA is better with regard to women in leadership than any other place I have ever worked.  And I wondered how this came to be.

To prepare for my new role, one of the things I have been doing is speaking with former FDA Commissioners, and I discussed this observation with Peggy Hamburg.

I asked her why she thought FDA was such a good place for women?  I had assumed maybe this was in part her doing, something she had emphasized when she was the Commissioner. But she said, not really, that this has been a longstanding part of the FDA’s culture.

This notion of culture shaping the institution, that resounded with me…

And so that really is my first observation about the FDA: the reason it is full of so many great people is because of a strong institutional culture.

A second impression, as immediately obvious as the first, is WOW, the FDA really has a huge portfolio!

As a biomedical researcher, I was more familiar with some aspects of the FDA like drugs and devices, but FDA has so much more than that.  Food safety and nutrition, veterinary medicine, the Office of Regulatory Affairs.

Put simply, we have a profound and lasting impact on every American – each day and throughout their lives.

From the food Americans put on their table, to the medical products they rely on, to the tobacco products they (hopefully) no longer use, to the cosmetics they wear and the foods or medicines they give their animals, and so many other ways.

Few institutions – public or private – can boast that kind of impact – or that kind of responsibility.  Which is another reason I look forward to this new role.

Frankly, this tremendous scope is intimidating, but I am getting over that.

I am now not so worried.  What puts one at ease regarding this overwhelming portfolio is what I already remarked on as the first impression: the FDA is full of great people.

I am confident that I can rely on the great leadership of all parts of the FDA to help advise me as I join you in taking on this significant public health responsibility….I feel like with your help, we’ve got this.

A third impression is that while I am thankful to be leading such a strong agency, we must acknowledge that we still face challenging headwinds.

Some of these challenges are similar to those experienced in other parts of government.

By far, my biggest challenge at NCI was related to hiring and human resources.

So when I came to FDA, I fully expected one of the biggest hurdles here to be hiring too.  And guess what:  in this area, the federal government does not disappoint.

If the FDA is going to remain great, and reach its full potential, if it is going to be able to accomplish its mission of protecting the public’s health, then we have to continue to build a diverse and talented workforce.

We need to do this to ensure that we keep up with the scientific and technological changes that have such an impact on the work we do.

We will have to do more to recruit and retain the best people and fill the many vacancies, and I have some ideas on this.

Aging infrastructure was also a problem at NIH, and I recognize this is a problem at FDA too.

I recognize that in the hundreds of facilities around the country that house FDA employees, there are some aging buildings and laboratories.  I’m committed to addressing the backlog in needed improvements.

There are also many important challenges that are unique to FDA.  That relate solely to our mission.

In food safety, how can we use modern technology like blockchain and artificial intelligence in a way that is maximally protective to the consumer, but also not onerous and debilitating to industry?

And how can we better address all of the problems relating to inspections and enforcement: counterfeiting, adulteration, untruthful advertising, marketing dangerous products to children?

How do we protect the American public from bad people in the world that put profit over safety?

And how to handle all these new products that present us with regulatory challenges:  electronic nicotine delivery systems (ENDS), gene therapies, CBD oil, genetically modified animals, cell cultured meat (and pet food).

I am beginning to suspect these thorny problems may be part of the reason we have so many lawyers around…

And these are just a few of the FDA-specific issues. Actually, the list here is really long, and I look forward to working with many in this room and watching online to learn about these issues and to figure out our path forward in these areas.

So that’s my third impression one week in:  the FDA faces a large number of challenges, and these will require our sustained and concerted efforts. 

My Plans at FDA

I am sure many of you would like to know specifically what I plan to do as Acting FDA Commissioner.

In the coming weeks, I will be highlighting some of my public health priorities, but let me make a few general points today.

First, I am a great admirer of Dr. Gottlieb.  Scott and I had long discussions about much of the business before the FDA, and he gave me great advice.

There will of course be some letup from Gottlieb:  for example, I don’t have nearly as interesting socks from a wardrobe POV.

On the plus side, I am pretty sure I can beat his time in the FDA 5K coming up this May 3 (since I am told he never ran it).  In fact, I am planning on setting the Commissioner’s Record.

And let me dispel any misconceptions that the change in leadership reflects some desire of the President or the Secretary for the FDA to go in a different direction from the Gottlieb era.

That is not the case, Secretary Azar and the White House have been very clear with me that they have been impressed with the FDA’s efforts and would like to see this strong progress continue.

Moreover, there is great support for the FDA’s mission in Congress.  This support is positive and bipartisan.

I’ve already experienced this first hand through a number of calls with key legislators and they’ve confirmed the high regard with which Congress holds the FDA.

So let me reassure you, I am not planning any radical changes from what the FDA has been trying to accomplish.

Necessarily, there will be course adjustments as new facts emerge, but essentially, I feel I am walking into an organization on a good trajectory, and my main job is to figure out how keep that going.

Now how to do that:  let me suggest two guiding principles.

First, I believe our efforts should rely on and be guided by the science.  As a researcher, I am used to letting data drive my decision-making, and I know this has always been the approach at FDA.

Second, when wrangling with the complex issues that face the agency, we will keep top of mind our mission of protecting and promoting public health, and what that means to the American public.

So that’s what will steer my priorities as Acting Commissioner:  a commitment to science-based decision-making and prioritizing our efforts for the benefit of the public health.

Forging Ahead

While my title may be Acting Commissioner, I assure you that I’m not acting as if this is a temporary or part time job.

I plan to maintain FDA’s current course of action in every area and proceed full speed ahead.

I promise you, for example, that we’ll continue our important and successful work to increase competition and reign in prescription drug costs through advances in our generic drug and biosimilars programs

And we’ll continue to do everything we can to make the development of new treatments and cures more efficient across our medical product centers, while ensuring that we maintain FDA’s gold standard of safety and efficacy.

Through our policies and in conjunction with other government agencies, we will also continue to develop new solutions to the opioid crisis, one of the greatest public health tragedies this nation has faced.

We’ll maintain our focus on ending the use of combustible cigarettes among adults, and on preventing kids from ever starting.  

That includes undertaking vital research to ensure we have the data necessary to make informed regulatory decisions on electronic cigarette products, so that we can reverse the growing epidemic of youth ENDS use.

We simply won’t tolerate misleading marketing or selling tobacco products to children.

We’ll continue our efforts to modernize and reform our oversight of dietary supplements.

That industry has grown tenfold over the last 25 years -- with estimated annual sales now exceeding $40 billion.

While these products can be beneficial, we’ll continue to protect consumers by cracking down on false and misleading claims.

Personally, as an oncologist, I have seen first-hand how charlatans will sell false hope to prey on desperate patients with cancer and other diseases.

It’s important we stand up for the consumer and expose fraudulent products, particularly those pitched to vulnerable populations.

I’m eager to support the fascinating and groundbreaking work going on in biologics. It will be good for patients to expedite the development of safe blood products, innovative cellular therapies, and other complex biologics products, including gene therapies.

At the same time, these new technologies bear watching:  we won’t tolerate dangerous stem cell clinics claiming to treat age-related conditions with highly dubious and unproven cellular products.

And I am committed to supporting the agency in communicating around the safety and effectiveness of vaccines to prevent infectious diseases like influenza, HPV, and measles, and to facilitate their broad use.

Any physician my age is horrified to see these outbreaks of measles, a life-threatening infection that we thought we had licked, but is now making a tragic comeback because of vaccine avoidance.

The rapid pace of technological development has had a major effect on the world of devices and diagnostics.  We’ve moved rapidly from tongue depressors to next generation sequencing in general commercial use.

So I look forward to supporting efforts to advance medical device safety and innovation, with initiatives like the Medical Device Safety Action Plan and the digital health pre-certification pilot.

As NCI Director, I was a champion of the use of real-world evidence as a means to speed clinical trials, and therefore, I am excited by plans for the National Evaluation System for Health Technology (NEST), to advance the use of real-world evidence to support regulatory decision-making around novel devices.

One area I’m especially excited to dive into is the essential work FDA does to drive the modernization of food safety and nutrition.

At NIH, I co-chaired a trans-NIH nutrition task force, and I appreciate the immense health impact of diet and nutrition, as well as the significant need for more and better research in this area.

FDA plays a really important role in improving the diet of all Americans (and therefore national well-being) through efforts in food and menu labeling, for example.

To that end, I look forward to building on this work and advancing FDA’s comprehensive multi-year Nutrition Innovation Strategy, and furthering the implementation of the landmark FSMA law, as well as other efforts to ensure more timely responses to foodborne illness outbreaks.

We will continue to support innovations in food technology like genome-edited plants for people and animals. But we will also continue to examine them through the lens of food safety.

I look forward to supporting and learning more about the important work of FDA’s Center for Veterinary Medicine and supporting the “One Health” approach to addressing public health challenges with respect to animal drugs and animal food.

The Center is fostering innovation of new animal drugs and animal foods with new policies and approaches like “conditional approval” and oversight of genetically altered animals.

Lastly, before I came to FDA, I had heard that the Office of Regulatory Affairs was the beating heart of the FDA.

I am excited to have the opportunity to work closely with ORA and support FDA’s critical role in the field. ORA’s dedicated force conducts inspections on behalf of the entire agency.

Their enforcement actions – both civil and criminal – are vital tools for protecting the public health.

Further, their work to inspect food and medical products at ports of entry and in International Mail Facilities are critical to keeping Americans safe.

This is just a quick summary of some of the exciting work at the FDA of which I am now privileged to be a part. And I want you to know I am fully committed to supporting the whole of the FDA’s agenda.

Conclusion/Q and A

This agency has a long and distinguished history of growing and responding to the changing needs of our society.  I want FDA to continue to be the best it can be for the American people.

And apparently, I’m already making a huge difference.  Next week we’re set to launch the new, improved FDA.gov website. Not a bad start.  Just one week in and I’ve fixed the website.

In all seriousness, the work done over the past year to get us here will provide a more accessible, user-friendly site for the public to learn about recalls, get product safety alerts, and other important information about the work we do to protect the public.  This will be important.

We live in an era of great scientific promise and medical opportunity. What we do supports and shapes these groundbreaking developments and makes a real and positive difference in the lives of people.

We do this because it’s our job. But FDA is so good at its job because of the extraordinary commitment of the people who work here.

It is my great honor to join you in that work.  And I look forward to collaborating with and learning from all of you.

Thank you.

And now I look forward to answering some questions!  As a reminder, if you have questions please send them to the end of the aisle. Keagan, I am happy to take the first question.