- Speech by
Stephen M. Hahn, M.D.
Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )
Thank you for this invitation to speak at FDLI’s annual law and policy conference.
It is the role of a regulatory agency like ours to enforce the law and to help shape the development of that law.
Of course, our efforts also have an impact on your work. And vice versa.
The membership of FDLI is a diverse group comprising some of the most engaged and influential stakeholders in the FDA’s landscape.
Your expertise and understanding of the laws and the processes we apply in our mission to protect and promote the health of the American public play a key role in shaping and strengthening the work of the FDA.
We value that input … even when we may not agree with it.
And so, I am especially grateful to have this opportunity to come before you, even during this public health emergency.
I know that in the past, Commissioners’ speech to FDLI have been referred to as the “State of the FDA” speech.
This year, obviously, is a bit different. For all of us. Certainly, nothing this year has been what I anticipated back in December when I came to the FDA.
But I believe I can capture the essence of the “State of the FDA” fairly quickly and concisely. And that status is … busy. Very, very busy. But also productive. And continuing to be very committed to the health and safety of the American public.
Let me begin by explaining why I think the FDA has been so successful in its continuing efforts not only to address the COVID-19 public health crisis, but why it is so successful in times when there is no public health crisis.
The answer is, quite simply, the professionalism, knowledge, and commitment to its public health mission that the 17,000-plus employees of the FDA bring to their jobs every day.
Now, this audience probably knows better than most just how capable the FDA staff is in filling their vast range of responsibilities.
Throughout this pandemic, I’ve seen our staff immersed in a round-the-clock, multi-faceted, super-accelerated response to COVID-19 – an effort that essentially has involved a doubling of the workload.
But I’ve also seen, in the face of this incredible challenge, how our centers and offices continued to fulfill the Agency’s mission-critical responsibilities. You know us well enough that you don’t need me to spell them out for you.
Here’s just a sampling of the agency’ many accomplishments, in both the COVID and non-COVID areas.
I’ll start with the “F” in FDA – foods – and the agency’s critical role to ensure the safety of our food supply.
In a year when we’ve faced temporary shortages as a result of food supply chain issues and worked with our partners at CDC and OSHA to help employees and employers in affected food industries continue operations safely, we’ve also been able to advance a number of important new food safety initiatives.
In July, I announced the release of the New Era of Smarter Food Safety Blueprint, which outlines the steps the FDA will take over the next decade to create a more digital, traceable and safer food system – to minimize the impact of foodborne illness in this country by reducing the number of illnesses.
Through this plan, we will be leveraging new and emerging technologies and modern tools and approaches to build on the work we’ve done and continue to do through implementation of the FDA Food Safety Modernization Act.
The challenges of the pandemic have only clarified that our New Era goals will strengthen how we approach the safety and security of the food supply. For example, we learned that enhanced traceability will not only help rapidly trace a contaminated food to its source but could also help provide greater supply chain visibility and potentially help the FDA and industry anticipate the kind of marketplace imbalances we’ve seen in recent months.
Another important milestone occurred earlier this year, with the release of the 2020 Leafy Greens STEC Action plan to outline a collaborative, action-oriented approach to enhancing the safety of leafy greens.
We also launched two education campaigns, one to raise consumer awareness of the New Nutrition Facts label, another called “Feed Your Mind” – in partnership with the U.S. Department of Agriculture and the EPA – to provide science-based information on genetically engineered foods, commonly called GMOs.
I’ll turn next to the work of the newest FDA Center, our Center for Tobacco Policy
With only a little over a decade in this regulatory space, the FDA has made important strides in tobacco regulation. Through rigorous research, attentive oversight for legal compliance, and science-based public health education, CTP is effectively regulating a complex and rapidly changing tobacco landscape.
As you may recall, earlier this year, before COVID-19 appeared, our nation and the FDA were addressing the alarming increase in the use of e-cigarettes among our youth.
As a cancer doctor who has cared for lung cancer patients, I know only too well, the health implications of nicotine addiction and combustible tobacco use. And we know that young people who experiment with e-cigarettes are more likely to try combustible cigarettes.
Last month marked an important milestone in this effort – the premarket review submission deadline, when manufacturers of deemed, new tobacco products – including many currently on the market – submitted their premarket applications to FDA.
Finally, deemed products are now in line with the cigarettes and smokeless tobacco products already subject to premarket review under the statute. The FDA conducts a robust scientific review to determine if a new tobacco product meets the criteria for receiving FDA authorization.
Last month also saw the release of the 2020 National Youth Tobacco Survey, which offered some good news: an overall decline in youth e-cigarette use with about 1.8 million fewer U.S. youth currently using e-cigarettes (compared to last year).
There is more to do. 3.6 million youth are still current users of e-cigarettes. Moreover, the data also shows an alarming increase in the number of youth who use disposable e-cigarettes.
The FDA will continue to be aggressive in both enforcement and education in this important area of public health.
Like the rest of FDA, our Office of Regulatory Affairs has also been pulling double duty during the pandemic.
In March, to ensure the health and well-being of our staff and others who conduct inspections for the agency, the FDA announced the Agency was temporarily postponing all domestic and foreign routine surveillance facility inspections and focusing on mission-critical inspections on a case-by-case basis. In July, the Agency began working to resume prioritized domestic inspections.
We also continue to use a number of other tools to help keep the medical products and food supply safe, including denying entry of unsafe products offered for import into the U.S., conducting physical examinations and product sampling at our borders, and continuing to work with federal, state and local partners to monitor the medical product and food supply for indications of interruptions or shortages.
In addition, we are expanding our working relationship with the US Postal Service, US Customs and Border Protection and planned the establishment of satellite laboratory operations at selected International Mail Facilities, bringing scientists with special training and advanced tools for rapid testing to these points of entry. The first of these laboratories is in operation at the Chicago IMF.
When it comes to giving your all in a public health emergency, no group of public employees do it more or better than our Commissioned Corps officers.
The officers of the Public Health Service have made a unique commitment to public health and public health programs, and they work in every area across FDA – not to mention in every corner of the globe, in some of the most treacherous areas and situations on our planet.
During the COVID-19 pandemic, FDA Commissioned Corps officers have deployed 885 times in support of the COVID-19 mission, including many more than once. Officers have traveled far from their homes to provide critical assistance to some of the hardest hit communities in the U.S. They are on the front lines, and we are proud and grateful to their service to the FDA and the nation.
Our medical product centers have been especially focused on addressing the challenges of this pandemic, supporting the development of safe and effective medical countermeasures, from ensuring that our front-line health care workers had and will continue to have the necessary protective equipment, to providing essential regulatory advice, guidance, and technical assistance to advance the development of tests, therapies, and vaccines.
As you know, our Centers for Drug Evaluation and Research (CDER) and our Center for Biologics Evaluation and Research (CBER) developed the Coronavirus Treatment Acceleration Program, called CTAP, which uses every available method to move new treatments to patients as quickly as possible, while at the same time ensuring that they are helpful, not harmful.
As of last month, there were more than 590 COVID-19 drug development programs in the planning stages, 310 trials reviewed by FDA, and five COVID-19 treatments authorized for Emergency Use.
CDER has also taken a number of actions to help meet the increased demand for hand sanitizers, while at the same time protecting the public from poor quality and potentially dangerous hand sanitizer products.
But as I’ve said, the FDA has also continued to meet the broader demands of the nation related to non-COVID medical products.
As of September 8, CDER has approved 40 novel drugs, addressing a wide variety of illnesses. including 15 new drugs to treat patients with various forms of cancer.
Sixty percent of these new drugs will help patients with rare diseases.
And more than three out of every four of these products were approved in the U.S. before any other country.
We have also continued our pace on generic drugs. As of July 31, 2020, we have approved more than 400 generic drugs, including 38 first generics. We have made strides in improving patient access to insulin, issuing guidance that describes our streamlined approach to demonstrating biosimilarity and interchangeability for these products.
Our Center for Devices and Radiological Health (CDRH) has made enormous contributions to the COVID-19 response. To give you a brief idea, as of Sept. 18, they have issued more than 515 Emergency Use Authorizations (EUAs), which is more than ten times the number authorized in all prior national emergencies combined.
The diagnostic tests, personal protective equipment, infusion pumps, ventilators, and other devices authorized under these EUAs have been instrumental in the public health response.
CDRH also worked closely with developers and manufacturers to encourage them to design and manufacture devices they had probably never considered making until now.
And they’ve facilitated alternative testing strategies to help address supply shortages.
At the same time, they’ve also continued to embrace important initiatives, such as the launch of our Digital Health Center of Excellence, which will focus on aligning digital health efforts and act as a hub for regulatory innovation.
Finally, let me recognize the extraordinary work of CBER, which continues to apply its expertise and embrace its many different responsibilities, from helping to ensure the safety of the blood supply to the review and approval of new biological products.
Of course, what most of the nation is focused on today is if and when CBER and the FDA will approve or authorize a COVID-19 vaccine.
The development and approval of vaccines and therapeutics to prevent and treat COVID-19 holds the promise to alter the course of this pandemic.
We certainly want new products to come to market as quickly as possible to help prevent additional illnesses and deaths. But if a national vaccine campaign is to be successful, the American public must have full trust in the FDA’s review process.
Which is why it’s so important that the expert career scientists of CBER, under the direction of Dr. Peter Marks, are laser-focused on this issue.
It is critical that the American public has complete confidence in this decision-making process. I want to assure them, and you, that the FDA will not authorize or approve any COVID-19 vaccine before it has met the Agency’s rigorous expectations for safety and effectiveness.
In this effort, science will guide our decisions. FDA will not permit any pressure, from anybody, to change that.
We can emerge from this pandemic only if we work together, learn from each other, and are driven by the facts and data.
I know that the FDA has received criticism over some of its decisions during the pandemic.
Intense scrutiny is part of the job, particularly at an agency that makes so many vital decisions relating to the health and safety of the public.
But the criticism we get should never undermine the underlying faith the public has in the FDA and our commitment to protecting the public health.
Every one of the decisions we have reached and that will be made by FDA scientists has been and will be based on science and data, not politics.
And though I can’t say when, we will come out of this stronger. To ensure this happens, we are regularly reviewing our response and applying the lessons learned to future challenges.
To this end, we recently launched the COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP), which focuses on identifying avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products.
We are also gathering insights from external stakeholder groups ranging from patient advocacy, academic and healthcare professionals, industry and trade groups whose members have been on the front lines, to help shape potential areas of focus.
We know that we can count on FDLI for your input on these issues and on every issue in which the FDA is engaged.
I thank you for that involvement and commitment.
I look forward to our continuing collaboration so that we can together overcome whatever challenges we face, and embrace the many opportunities we have before us.