Remarks by Dr. Hahn to the FDA-CMS Summit December 7, 2020

Speech | Virtual

• Speech by: Stephen M. Hahn, M.D. ; Commissioner of Food and Drugs - Food and Drug Administration ( December 2019 - January 2021 )

---

I’m delighted to be with you today for this important meeting, which takes place, as the conference title accurately captures, in the midst of “the COVID era.” 

As sister organizations under the HHS umbrella, the FDA and CMS have unique health-related obligations and individual responsibilities to the public.  At the same time, I am pleased that we have a very strong and close working partnership on many different issues.

For the better part of the past year, the SARS-CoV-2 virus has reshaped our lives, forcing us to adapt the way we live and work, producing enormous economic hardships, disrupting families and communities, and causing profound personal pain and tragedy.

As we continue to battle this novel virus, we will no doubt face even more adversity before we can resume life as we once knew it.  The just commenced holiday season, which I’m sure you agree is one like no other in recent memory, offers an example.  But it is important that for the foreseeable future we continue to be vigilant and safe in our response to this disease, to meet it with responsible behaviors and actions that help keep us safe. 

The good news is that we are making important scientific progress.  Each day brings greater knowledge and new understanding of this novel virus, and with it increased promise of meaningful treatments and preventive measures that will keep us safer. 

The FDA has been working non-stop since the beginning of this pandemic to help gain greater understanding of COVID-19.  I am extremely proud of the hard work demonstrated by the Agency’s committed public health professionals.  

The FDA has applied enormous resources and tools in our search for solutions and to support the nation’s medical needs. 

We’ve seen this in many different areas – from our response to the need for personal protective equipment, ventilators, and other essential medical devices and products; to our work to combat the sale of fraudulent COVID-related products; and, of course, in our continuing support to develop therapeutic products and vaccines in response to this unprecedented public health emergency.

The FDA staff has engaged in ‘round-the-clock work even as they have remained focused on meeting the FDA’s regular, mission-critical public health responsibilities. 

Duties like reviewing and approving new medical devices, approving safe and effective new drugs and biological products, responding to health crises like the opioid epidemic, ensuring our continuing oversight of tobacco products, (including e-cigarettes), and maintaining our high standards of food safety and helping ensure the security of our food supply, just to name a few.

Of course, COVID-19 continues to be a primary focus of our work. And it’s no surprise that the FDA has responded so effectively to this emergency. 

That’s because these efforts are a key part of the agency’s mission to protect and promote the public health, using the most rigorous science and best data available.  One might say that the FDA is uniquely equipped to respond to this kind of public health emergency.

This approach has helped us develop strategies to respond to public health crises as wide-ranging as the Ebola Virus outbreak, from foodborne diseases, and dangerously tainted medical products. 

One important tool we have used to great effect during the 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.

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 before the products had been studied fully and to the same level as an approved product.

Regarding any Emergency Use Authorization for a vaccine, we will approach it in our customary way, carefully considering the benefits and risks. 

Since the start of the emergency, the FDA has been able to use the EUA to provide a speedy response to the nation’s unprecedented demand for diagnostic tests, PPE, and other medical products. 

For instance, in recent weeks we have issued an EUA for the first COVID-19 diagnostic test for self-testing at home that provides rapid results, and EUA’s 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 300 Emergency Use Authorizations covering more than 600 products. That’s more than 10 times the amount of EUAs issued for all previous public health emergencies combined. 

As we have proceeded along this emergency pathway, I’m pleased that we are also seeing products used to treat COVID-19 progress from an initial emergency use authorization to full approval using the traditional approval pathways.  That was the case with the first FDA approved drug Veklury ([remdesivir).

As you are aware, much of the current focus around the nation involves the development of a safe and effective vaccine.   The FDA continues 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. 

In recent weeks, we’ve seen some very promising developments.  Two manufacturers have submitted requests to the FDA to authorize the emergency use of vaccines that have completed stage 3 clinical trials.  Others are moving through the pipeline. 

I can’t speculate what will happen on this or any product that is submitted, as all the data must first be reviewed by FDA’s career scientists.  But I can say, with complete assurance, that they will receive the most careful scrutiny.

While speed in reviewing these products is important, so is ensuring that any approval or authorized vaccine meets the Agency’s rigorous standards for safety, accuracy and effectiveness.  And we will not authorize or approve any COVID-19 vaccine until such an approval or authorization meets the relevant statutory standard.

Additionally, we are committed to being as transparent as possible about the scientific basis for EUAs, in order to promote public confidence in the FDA’s scientific review 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 developer should provide to us so that we can review and approve or authorize a vaccine.

Another way is by having any vaccine submitted for authorization reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC.

This advisory committee consists of external experts who provide non-binding recommendations to FDA related to data concerning the safety and effectiveness of vaccines and other biological products. 

They currently have two meetings in open session scheduled -- on December 10 and December 17 -- to discuss the requests for Emergency Use Authorization of the Pfizer and Moderna COVID-19 vaccines, respectively. 

We believe this transparency should help reassure the public regarding FDA’s commitment to ensuring that any vaccine meets its rigorous standards for quality, safety and efficacy.

Another key aspect of the FDA’s work and capabilities is based on our ability to apply what we have learned both in previous crises and from the current crisis – to adapt and strengthen our approaches as needed, rather than simply to be reactive.

For instance, we are always reexamining our regulatory policies and procedures to make them more efficient and effective.  During the current pandemic, we have redoubled those efforts. 

We’ve streamlined processes to make it easier for developers and scientists to send inquiries and requests.  And we’ve speeded up the availability of guidance documents for industry, which provide greater clarity, transparency, and regulatory flexibility on a wide variety of topics, from diagnostics to the conduct of clinical trials. 

We’ve also worked to identify ways to increase coordination of scientific leadership, agency operations, communications, and programming for all regulated products.  In June, we launched the COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP), which is helping to support this kind of collaboration and communicating across the agency.

One model of this is the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program initiated by our Centers for Drug Evaluation and Research and Biologics Evaluation and Research that increases coordination for moving new treatments to patients as quickly as possible, while maintaining our focus on safety. 

When CTAP was initially launched, 72 clinical trials of potential therapies for COVID-19 were underway with FDA oversight. As of October 31, more than 560 drug development programs were in planning stages.  In addition, FDA has reviewed over 370 trials,  and authorized 5 COVID-19 treatments for emergency use, and  approved 1 treatment for use in COVID-19. 

We’ve also taken a fresh look at how clinical trials can be designed and conducted, and at the data sources that can aid in our evaluation of medical products.

For example, the availability of digital health data holds promise to inform product development for COVID-19. 

And 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. 

It also has the potential to provide a wealth of rapid, actionable information to enable us to better understand disease symptoms, describe and measure immunity, and anticipate -- and help mitigate -- potential shortages of medical products.

Still another way we are strengthening our work, both in our response to the pandemic and for future preparedness, is through our efforts to increase the diversity of participants in clinical trials.
 
While this has a been an FDA focus for a number of years, it is especially important when trying to find treatments and cures for 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.

We recently issued a final guidance with recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics.

Increasing diversity in clinical trial participants will help ensure a more complete analysis and understanding of differences in response, which in turn will help us ensure that the products we approve are safe and effective for those who will use them and better meet the health needs of all patients.

Another key area that applies both to our ability to respond to the current pandemic, as well as to support our preparation for the next potential public health emergency, involves identifying and ensuring the continued supply of essential medications.

Recently, the FDA identified a list of 227 essential drug and biological product medicines and 96 device medical countermeasures that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate form of dosage.

These include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, active vital sign monitoring devices, devices for vaccine delivery and devices for management of acute illnesses such as ventilators, among others.

We are coordinating with our federal partners, to ensure sufficient and reliable, long-term domestic production of these products, and to minimize potential shortages by reducing our dependence on their foreign manufacturers. This will help ensure the American public is protected against future outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats.

One way we are working to achieve this goal is through the adoption of innovative technologies, such as advanced manufacturing. This has the potential to increase access to critical medical products, lower production costs and decrease the risk of supply disruption. 

At the same time, it provides a more flexible and agile manufacturing capability to respond to emerging infectious diseases and disease outbreaks and helps ensure a stable supply of drugs critical to the health of U.S. patients.

In closing, I want to mention one final way we are working to protect and promote the public health, both in the current COVID era, and in the future.  That relates to the confidence the public has in the FDA and our review process.

This confidence is important 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.  But only if people have full trust in the FDA’s review process and take the vaccine when it is available.

We will continue to do what we do best – to apply the best science and rigorous review of the data to support well informed decisions.

With this approach – and with the faith of the public – I am confident that we will soon be able to return to a more normal, safer, and healthier daily life.

Thank you.