- Speech by
(Remarks as prepared for delivery)
I’m delighted to be with you for this important meeting. Your agenda encompasses many of the critical public health issues we face today, and I’m pleased to be part of the conversation.
It’s especially appropriate that I have the opportunity to follow Dr. Nunez-Smith’s insightful talk. Her work underscores so many of the challenges in public health today. Ensuring equity is a goal that the FDA continues to prioritize throughout our scientific work, in everything from access to clinical trials to the availability of treatments. It is an issue with special resonance as we search for treatments to new diseases like COVID-19 in which certain segments of the population, including older adults, pregnant women, children, and racial and ethnic minorities, have been affected differently.
I’m also pleased to see several of FDA’s sister agencies at HHS on the agenda. The pandemic has reaffirmed the importance of a cross-government response. I’m pleased that we have worked closely with the Centers for Disease Control and Prevention, the National Institutes of Health and other HHS and government agencies to fulfill our responsibilities to the public.
As we all understand, the SARS-CoV-2 virus has reshaped our lives and, to some degree, health policy. It’s now been a little over a year since our society was forced to shut down or reconfigure how we live and work.
During that year, we’ve seen enormous economic hardships, incredible disruption of families and communities, and profound personal pain and tragedy.
There is cause for optimism, however. We’ve made and continue to make important scientific progress.
Each day brings greater knowledge and understanding of this novel virus, and with it increased promise of meaningful treatments and preventive measures that will keep us safer.
Certainly, the development and authorization of now three vaccines was an important step forward. I’ll talk about that and some of the other scientific developments shortly.
But at the outset I think it’s important to emphasize that even with a potential return to something approaching normalcy on the horizon, we must remain vigilant in our response to this disease. We must continue to meet this challenge with responsible behaviors and actions that keep us safe.
At the FDA, we’ve been working non-stop since the beginning of this pandemic to gain greater understanding of COVID-19, and to support the development of treatments and tools to respond to this unprecedented public health emergency.
That work has included expediting access to COVID-19 medical countermeasures for the diagnosis, prevention, and treatment of COVID-19, supporting the stability and quality of medical product and food supply chains, and ensuring that the Agency’s decisions are guided firmly by science, using open and transparent processes to ensure continued public confidence.
We’ve responded to the need for personal protective equipment, ventilators, and other essential medical devices and products.
We’ve worked to combat the sale of fraudulent COVID-related products.
And, of course, we’ve been engaged in efforts to support the development of therapeutic products, tests, and vaccines.
I want to call out our FDA staff, who have demonstrated extraordinary effort and resilience in responding to this public health crisis, in many cases working, quite literally, 24-7.
Equally impressive and important, while taking on this all-encompassing work, they have remained focused on meeting the Agency’s wide-ranging, ongoing public health responsibilities. This means continuing to review and approve or clear new medical devices, approve safe and effective new drugs and biological products, respond to health crises like the opioid epidemic, ensure our continuing oversight of tobacco products, (including e-cigarettes), and maintain our high standards of food safety and food-supply continuity, to name just a few.
I can think of a number of reasons why the FDA workforce has managed to so effectively steer two ships at the same time.
One reason is training and dedication. And I can’t say enough about our staff in that regard.
But there is an important second reason, which involves the role, mission, and mandate of the Agency, which make us uniquely prepared to respond to public health crises like this one.
While the COVID-19 pandemic is unprecedented in many ways, it’s certainly not the first significant international public health emergency the FDA has dealt with.
We’ve responded effectively to crises as wide-ranging as the Ebola, H1N1, and Zika viruses, a number of horrific natural disasters both domestically and internationally, expansive and dangerous outbreaks from foodborne illnesses, and dangerously tainted medical products.
Over time, we’ve developed and been provided a range of tools and approaches to help us respond effectively to public health emergencies.
For example, since the very beginning of this pandemic, we have worked to make our regulatory response more nimble.
We’ve streamlined processes to make it easier for developers and scientists to send us inquiries and requests, and we’ve developed guidance documents for industry to provide greater clarity, transparency, and regulatory flexibility on a wide variety of topics, from diagnostics to the conduct of clinical trials.
We’ve responded with appropriate flexibility when necessary and possible to address public health needs.
One example is the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program initiated by our Centers for Drug Evaluation and Research (CDER) and Biologics Evaluation and Research (CBER) that increases coordination for moving new treatments to patients as quickly as possible, while maintaining our focus on safety. When CTAP was launched, 72 clinical trials of potential therapies for COVID-19 were underway with FDA oversight. As of January 31, more than 600 drug development programs were in planning stages. In addition, FDA has reviewed over 420 trials, and authorized 8 COVID-19 treatments for emergency use, and approved 1 treatment for use in COVID-19.
We’ve continued to build on the pre-pandemic work we were doing, taking a fresh look at how clinical trials can be designed and conducted, as well as the data sources that can aid in our evaluation of medical products, such as digital health data.
The use of real-world data – data collected outside of traditional clinical trials-- can help accelerate FDA’s understanding of how COVID-19 is affecting patients and help FDA advise product developers on how to optimize the design of clinical trials.
And we’ve collaborated with our partners in federal and state government, as well as with external stakeholders representing industry, academia, patients, and the health care community.
Experience has shown us that these collaborations are an essential ingredient in this kind of response, and they have made an important difference in the health and lives of millions of Americans every day.
Let me give you one quick example of where this has been so important – supporting food safety and security. The FDA has worked closely with our federal, state, and local partners throughout the pandemic, as well as with industry, to help ensure a safe and adequate food supply for both people and animals.
One tool that we have used to great effect during this pandemic is the Emergency Use Authorization (or EUA), created by Congress specifically to provide us with the means to respond quickly during a public health emergency.
As you may recall, Congress developed the EUA after the terrorist attacks of 9/11 to ensure that potentially lifesaving medical products could be available to people in medical need when there is not an adequate, approved and available alternative.
Since the start of this emergency, the FDA has used the EUA mechanism to provide a speedy response to the nation’s unprecedented demand for diagnostic tests, PPE, and other medical products, including authorizing three vaccines for emergency use.
For instance, in recent weeks we have issued an EUA for the first over-the-counter COVID-19 diagnostic test for self-testing at home that provides rapid results, and EUAs authorizing the use of monoclonal antibodies for COVID-19 treatment, which is designed to block the virus’ attachment and entry into human cells.
Overall, during the pandemic, we’ve authorized more than 350 EUAs enabling access to more than 700 products. That’s more than 10 times the number of products previously available under EUA for all previous public health emergencies combined.
One area that I know everyone has been closely following in this regard is our work to facilitate expedited vaccine development and to provide rapid feedback and technical advice to sponsors and researchers regarding the data needed to support the manufacturing, clinical development, and approval or authorization of COVID-19 vaccines.
As I mentioned, we’ve now authorized three vaccines for use in preventing COVID-19. Others continue to move through the pipeline.
The EUA pathway, as it was intended, allowed us to rapidly review and authorize use of these vaccines. But in each case, the data and information on safety, effectiveness and manufacturing quality were assessed by FDA’s career scientists and physicians in our customary way. All the authorized vaccines were shown to satisfy the relevant statutory standards, and FDA scientists carefully considered the known and potential benefits and risks.
The other important aspect to understand about the EUA process is our commitment to transparency about the scientific basis for authorization of COVID-19 vaccines. We need and want to promote public confidence in the process and, ultimately, in ensuring that the authorized products are used appropriately.
One way we have advanced this transparency is to make clear, through several guidances, the information a vaccine developer should provide to us so that we can review and approve or authorize a COVID-19 vaccine.
Another way is that each vaccine submitted for authorization is reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of external experts who provide non-binding recommendations to FDA related to data concerning the safety and effectiveness of vaccines and other biological products. The Committee meets in open session to discuss each EUA vaccine request.
Finally, I want to point out another important way the FDA is flexible and responsive – and that is in the way we are able to quickly address ongoing scientific developments such as the emergence of new variants of SARS-COV-2. The FDA had anticipated the possible emergence of SARS-CoV-2 variants and was prepared to address changes in the virus. We were informed in our work because of our previous work with evolving infectious diseases like influenza and HIV.
Late last month, shortly after discovery of these variants, the FDA issued four guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of the virus.These guidances provide FDA’s recommendations for developers of medical products that either are in the pipeline or have been authorized for emergency use to efficiently address emerging variants. And we will continue to develop new answers and pivot as the virus adapts.
The vaccine guidance, which supplemented our ongoing communications with individual vaccine manufacturers, outlined FDA’s scientific recommendations for modifications to authorized vaccines. For instance, the guidance clarified that the FDA expects that manufacturing information will remain generally the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer.
For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. And it outlines our recommendations for assessments of safety to support an EUA for a modified vaccine.
The testing guidance on variants similarly outlines FDA’s recommendations to test developers, and our work to monitor the impact the new variants are having on test performance.
The FDA has already issued a safety alert to caution that the presence of viral genetic mutations in a patient sample can potentially change the performance of a diagnostic test. And we have identified a few tests that may be impacted by emerging viral mutations, though at this time the impact does not appear to be significant.
And the therapeutics guidances on variants provide recommendations for developers targeting monoclonal antibodies as they may seek to make adjustments in response to variants, as well as other drugs or biological products targeting SARS-CoV-2.
In short, we continue to apply what we have learned in previous crises as well as the current one – preparing, adapting, and strengthening our approaches as needed, rather than being simply reactive.
As you can see, the FDA’s responsibilities and activities in response the COVID-19 pandemic are wide-ranging. In fact, I’ve only touched the surface of the many different aspects of that response.
But before I close, I want to mention one final important way we are working to protect and promote the public health, both in the current COVID era, and in the future, and it’s one that you can play a role in.
It relates to the confidence the public has in the FDA and our review process.
Ensuring this confidence is essential for any product we authorize or approve, but particularly so in the context of a national vaccination campaign for COVID-19.
The development of vaccines and therapeutics to prevent and treat COVID-19 holds the promise to alter the course of this pandemic. People need to have full trust in the FDA’s review process and take the vaccine when it is available.
They need to understand that the FDA applies the best science and most rigorous review of the data to support the most well-informed decisions.
I look forward to working with all of you to disseminate this understanding. In this way, we can move ever faster to the resolution of the current public health emergency and a return to a more normal, safer, and healthier daily life.