Dr. Hahn’s Remarks to the Meeting of the Regulatory Affairs Professionals Society (RAPS) – 11/17/2020
Anonymous (not verified)
Fri, 11/20/2020 – 13:22
(Remarks as prepared for delivery)
Good afternoon. I’m delighted to be with you today.
This group understands, perhaps as well as any, the importance of the FDA and the difference that effective regulations can make in helping meet the needs of patients and consumers and ensuring their safety.
You appreciate how the application of regulatory science benefits the public by helping speed the development and approval of safe, high-quality medical products.
And you recognize that this role is only magnified during public health crises like the one we are currently facing – in part because the FDA is uniquely prepared to help the nation respond.
As an agency focused on using science to protect and promote the health and safety of the American public, the FDA has been engaged in combatting the COVID-19 pandemic for nearly nine months now. At times, it has been a painful period, one that has caused our families and communities to change how we live. It has triggered enormous economic and social disruption. And worst of all, this disease has led to many personal tragedies.
At the FDA, we have been working since the earliest days to advance a far- reaching response, putting enormous resources and tools to work in our search for solutions.
Our resourceful and resilient workforce of nearly 18,000 strong has been immersed in critical, around-the-clock work to support the development and availability of medical countermeasures to combat COVID-19. It has, in effect, doubled the agency’s workload. At the same time, staff across the agency, including senior leadership, have remained focused on the FDA’s other important, public health work continuing to fulfill its mission-critical responsibilities.
As we have sought answers and worked to reach sound decisions, the FDA’s North Star has been, as always – the application of rigorous science and good data.
This solid foundation has enabled the agency to address testing supply shortages, expand increases in personal protective equipment, ventilators, and other essential medical devices; ensure continued access to necessary medical products; counter the sale of fraudulent products; and support the development of therapeutic products and vaccines.
As our mission remains to protect and promote the public health, it makes sense that the FDA is uniquely prepared to respond to this kind of public health emergency.
Part of this ability comes from having the regulatory strength that enables us to move quickly and safely to support medical developments, and to be flexible in how we adapt these processes when necessary.
It also comes from having the necessary regulatory tools to respond appropriately and quickly.
For example, after the terrorist attacks of 9/11, Congress created the Emergency Use Authorization, designed to ensure that potentially lifesaving medical products could be available to people in medical need before they had been fully studied to the same degree as approved products.
The FDA has used the EUA to strengthen our response to the pandemic and the unprecedented demand for diagnostic tests, PPE, and other medical products.
Since the start of this emergency, we have granted more than 300 Emergency Use Authorizations (EUAs), some of which authorize multiple models of devices, totaling more than 600 individual authorized products.
To put this in context, that is more than 10 times the amount of EUAs issued for all previous public health emergencies.
And the diagnostic tests, PPE, ventilators, and other devices authorized under these EUAs have been essential components in the public health response to this pandemic.
The EUA is more than just an effective regulatory tool. It’s science in action. It enables us to move as quickly and safely as possible to support the development of essential products in emergency situations such as the one we are in.
They involve real-time decisions using rapidly-evolving data about a previously unknown, highly contagious virus. The fact is, we are still learning about it, more every day.
If and when we are asked to consider an Emergency Use Authorization for a vaccine, we will approach it the same way, carefully considering the benefits and risks.
This helps us to ensure the safety of patients, and to recognize that these decisions may be changed or reversed as new data emerge.
It is akin to how a doctor might approach a patient in an emergency situation, constantly updating a treatment plan as new data is revealed.
We also are committed to be 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 using the authorized products appropriately.
We have recommended, through several guidances, the information a developer should provide to us so that we can review and approve or authorize a vaccine, including the chemistry, manufacturing and controls information, nonclinical and clinical data, regulatory and administrative information, and safety and effectiveness data.
As I said, science in action.
I want to point out one other thing about EUAs – and that is that they are intended for use during an emergency situation. At some point, the current public health emergency will end, and we will move into a new stage of pandemic response.
We recognize that this change and the subsequent return to normal operations by manufacturers will involve a period of adaptation and adjustment — for medical product manufacturers, healthcare facilities, healthcare providers, patients, consumers, as well as the FDA.
To this end, the FDA is evaluating the approach for handling this transition to normal operations for medical products distributed under emergency use authorities or enforcement policies.
We will continue to work with sponsors that are pursuing approval or clearance of these critical products, and we plan to issue guidance and other communications to stakeholders on the path forward, including for products that have not received FDA clearance or approval when the emergency ends.
Other aspects of our response will not change. For example, our work is informed and strengthened by our research, investigation and enforcement mechanisms, and by our efforts to strengthen our rulemaking apparatus and make our regulatory tools more efficient. These practices will continue.
We also are working to apply lessons learned from this crisis to support our response to future situations – just as we have applied to this crisis our prior experience in responding to a wide range of previous public health emergencies, including the Ebola Virus, outbreaks from foodborne illnesses, and dangerously tainted medical products.
The COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP), which was launched in June, focuses specifically on identifying avenues for improvement by coordinating scientific leadership, agency operations, communications, and programming across the agency for all regulated products.
Through our Coronavirus Treatment Acceleration Program (or CTAP), for example, we have used every tool at our disposal in our efforts to expedite the development and availability of potential COVID-19 treatments, provide sick patients timely access to new therapies where appropriate, and support vital research to further evaluate whether they are safe and effective.
CTAP has allowed us to enhance coordination to move new treatments to patients as quickly as possible. Consider that when CTAP was launched earlier this year, 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, over 370 trials had been reviewed by FDA, 5 COVID-19 treatments were currently authorized for emergency use, and 1 treatment was approved by FDA for use in COVID-19.
We’re also continuing to streamline many of our processes to make it easier for developers and scientists to send inquiries and requests.
For example, as part of the agency’s effort to make our decision-making process more transparent, we have begun phasing in a new Integrated Review documentation template, which is designed to support the assessment and documentation of new drug product marketing applications and enable us to more effectively communicate the basis for FDA’s decisions on applications. We are looking for your feedback and that of other stakeholders as we move forward on implementation.
We also have speeded up the availability of guidance documents for industry to provide greater clarity, transparency, and regulatory flexibility on a wide variety of topics, whether they apply to diagnostics or to the conduct of clinical trials.
We’ve accelerated the need to modernize technologies by investing in advanced manufacturing. This will increase access to critical medical products, lower production costs and decrease the risk of supply disruption, while providing a more flexible and agile manufacturing capability to respond to emerging infectious diseases and disease outbreaks.
We’ve also taken a fresh look at how clinical trials can be designed and conducted, and 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 has the potential to provide a wealth of rapid, actionable information to enable us to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate potential shortages.
Still another way we are strengthening our work, both in our response to the pandemic and for future preparedness, is through 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.
Each day brings greater knowledge and new understanding of this novel virus, and with it increased promise of meaningful treatments and preventive measures.
But as we move closer to these possibilities, it is important that keep in mind some very important principles.
First of all, while we all desire the successful and speedy development of these products, we cannot and will not shortcut the essential review our scientists must undertake to ensure the safety and effectiveness of any treatment or vaccine.
Speed in reviewing these products is important, but so is ensuring that the review meets the Agency’s rigorous standards for safety, accuracy and effectiveness.
We will not authorize or approve any COVID-19 vaccine until our career scientists have pored through the data and made sure that such an approval or authorization meets the statutory standard.
There is a second, related point why this is so important. That is because it is essential that the public have full trust in the FDA’s review process, complete confidence in whatever products we approve or authorize, and faith in the FDA and our commitment to protecting public health.
This confidence is particularly important when we begin a national vaccination campaign. Indeed, the guidances we issued on this subject were designed in part to help the public understand our science-based decision-making process and how it helps assure quality, safety, and efficacy for any vaccine that is authorized or approved.
Each of you can play an important role in this regard. Your understanding of the regulatory process, how it can support innovation, and how the FDA applies the best science and data to help us make well informed decisions, can go a long way to helping boost public understanding and confidence in the FDA and the products we authorize or approve.
That perspective is critical at any time, but even more so during a public health emergency.
I hope we can count on your support. From our vantage, the FDA will continue to apply its energy, resourcefulness, and scientific rigor to address these continuing challenges so that we can return to a more normal, healthier daily life.