Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration
June 5, 2020 — The following speech was delivered by Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration, presented on June 1 to the Alliance for a Stronger FDA, via audio broadcast, regarding the pandemic. Following is the transcript, which addresses his journey, and the challenges the nation faces.
"One of the most frustrating challenges each of us can face is the inability to control the events that affect our lives. Often, we are thrust into situations not of our own making. It’s no surprise that one of the most familiar adages concerns the best laid plans of mice and men going awry.
"And yet, to borrow another often-used saying, necessity is the mother of invention. History teaches us that crises often lead to accelerated change and innovations and new discoveries.
"This dynamic has been on my mind a great deal recently. It wasn’t too long ago – last December, to be exact – that I had the distinction of being confirmed as the 24th Commissioner of the Food and Drug Administration.
"This is the greatest honor of my life. I have long cherished the critical role the FDA plays in protecting and promoting the public health, and I’ve relied on the Agency’s expertise throughout my professional life."
A New Role
"So, I eagerly embraced my new responsibilities and the chance to make a real difference in public health. I was especially conscious that we live in a time of extraordinary scientific achievement, especially in oncology, with unprecedented opportunities to help make the lives of American patients and consumers healthier and safer.
"I quickly immersed myself in the Agency’s broad and complex responsibilities, seizing every opportunity to learn about the FDA, both those areas with which I’d previously had minimum involvement, such as food policy, and those with which I had more familiarity, like cancer treatments and innovative clinical trial design.
"I began to work with, and learn from, the agency’s extraordinary leadership team. I learned very quickly that the principles that have guided me throughout my life, such as my commitment to relying only on the best medical science and most rigorous data in support of advancing innovation and discovery, and my fundamental belief in promoting integrity and transparency in the scientific process, are the same principles that guide the FDA in both science and regulation.
"So, I was in the midst of transitioning from being Chief Medical Executive at MD Anderson Cancer Center to being Commissioner of FDA when our entire world was turned upside down with the appearance of the novel COVID-19 coronavirus.
"I certainly did not anticipate a public health emergency of this magnitude when I joined the agency. And I could not have imagined how significantly my new role would change and be shaped by this pandemic. I definitely could not have known that discussions about personal protective equipment (or PPE) or face masks or nasal swabs would be central to my work as Commissioner.
"One thing was apparent: I would need to manage this evolving situation even as I was still learning about FDA.
"From the very start I knew that even in a crisis situation – or perhaps especially because we are in a crisis situation – it is imperative that we maintain FDA’s high standards for evaluating products and making sure that the benefits outweigh potential harms.
"To maintain our standard, I pledged to myself and emphasized to my new colleagues at FDA that our decisions would always be rooted in science. Having spent my entire career as a physician and scientist caring for patients with cancer, I’ve always valued highly a commitment to good data and sound science. I feel comfortable working with the scientists at FDA because I know they not only share that value, that commitment, but that they will tolerate nothing less. So, it was critical to me, as the pandemic escalated that this be reinforced as the guidepost for all of our decisions.
"It may have been trial by fire, but I have the good fortune to work with an enormous number of talented individuals and teams who are helping guide us through this crisis. Every day they show extraordinary expertise, commitment, and resilience.
"I also was able to call on many from outside the agency, including former FDA leaders as well as colleagues from the medical community.
"What struck me was the uniformity of their advice. Those who formerly worked at FDA urged me to rely upon the FDA staff, many of whom have the experience to help manage a pandemic. My friends from outside the agency urged that we move quickly to make decisions, set direction and to be transparent about what we are doing. I have tried to follow all of this excellent advice."
Protecting the Food Supply
"Since this crisis and the actions of the FDA have evolved so rapidly, let me summarize what we have done. I am confident that the FDA has measured up to this unprecedented challenge.
"I want to start with the first word in the FDA’s name – food. Most of us take food safety for granted. But it takes a lot of hard work to maintain a safe food supply. This was true even before the COVID-19 pandemic but is especially challenging during an ongoing international crisis.
"During the pandemic, through the collaboration of the FDA, the food industry and our federal and state partners, we have been able to maintain the safety of the nation’s food supply. Our Coordinated Outbreak Response and Evaluation team remained on the job, monitoring for signs of foodborne illness outbreaks and prepared to take action when needed.
"And along with our federal partners, including CDC and USDA, we also have provided best practices for food workers, industry, and consumers on how to stay safe and keep food safe."
Diagnosing and Developing Treatments
"On the medical side, we immediately committed to facilitating efforts to develop diagnostic tests, treatments and vaccines for the disease. We have helped facilitate increases in our national testing capacity, have helped ensure continued access to necessary medical products, and have sought to prevent the sale of fraudulent products.
"If there’s one thing that’s been reaffirmed during this crisis, it’s the essential role of medical devices, including diagnostics, to countering this pandemic.
"From the earliest days of our response, we worked to ensure that we had the essential medical devices, including personal protective equipment, to help treat those who are ill and to ensure that health care workers and others on the front line are properly protected.
"To be sure, there were bumps along the road, but today we have an adequate supply of the devices that have been in unprecedented high demand such as PPE, ventilators, and others.
"We’ve reviewed and issued emergency use authorizations for medical devices for COVID-19 at an incredibly fast pace.
"And we’ve worked closely with many companies that don’t regularly make medical products but wanted to pitch in by making hand sanitizer, ventilators, or PPE.
"There was a special focus on the development and availability of accurate and reliable COVID-19 tests. We need to know who has the disease and who has had it. This is essential if we are to understand this virus and return to a more normal lifestyle.
"Since January, we’ve worked with hundreds of test developers, many of whom have submitted emergency use authorization requests to FDA for tests that detect the virus or antibodies to the virus.
"As you have seen reported, early in the crisis we provided regulatory flexibility for developers with validated tests as outlined in our policies because public health needs dictated that we do as much testing as possible. But as the process has matured, we have helped increase the number of authorized tests, and we have adapted some of our policies to best serve the public need.
"Today, if evidence arises that raises questions about a particular test’s reliability, we will take appropriate action to protect consumers from inaccurate tests. This is a dynamic process that is continually being informed by new data and evidence.
"We’ve used a similar dynamic process in the search for therapeutic treatments and vaccines.
"We are working closely with partners throughout the government and academia, and with drug and vaccine developers to explore, expedite, and incentivize the development of these products.
"More than 90 drugs are being studied, and FDA is actively working with numerous vaccine sponsors, including three sponsors who have announced they have vaccine candidates that are now in clinical trials in the U.S. More than 144 clinical trials have been initiated for therapeutic agents, with hundreds more in the pipeline. We don’t have a cure or vaccine yet, but we’re on our way, at unprecedented speed.
"Ultimately, of course, the way we’ll eventually defeat this virus is with a vaccine. FDA is working closely to provide technical assistance to federal partners, vaccine developers, researchers, manufacturers, and experts across the globe and exploring all possible options to advance the most efficient and timely development of vaccines, while at the same time maintaining regulatory independence."
Communicating and Educating
"There is much more to do going forward, and that includes research, exploration and discovery, and communicating what we know.
"As the country starts to reopen, it’s essential that the public understands what they need to do to continue to protect themselves. There has been a proliferation of information, and misinformation, on the internet and in other sources. Consumers need to understand that this virus is still with us and that we, as individuals and communities working together, need to take steps to continue to contain its spread.
"The FDA has an important part to play in communicating public information to all populations in the U.S. FDA has increased outreach by developing and disseminating COVID-19 health education materials for consumers in multiple languages to diverse communities and the public overall. Everyone should have a clear understanding of why hand-washing and social distancing remain essential. Consumers need to think about how to shop for food safely. People need to know when to call their doctors and when to ask about getting tested. Health care professionals need to know how to manage their patients in this new environment, and how best to apply telemedicine, the use of which is rapidly accelerating.
"I want the FDA to serve as a national resource for the public and health care community. I regard educating the public and providing accurate, reliable, up-to-date information as not just an Agency priority, but one of my own personal responsibilities as Commissioner. I will be out in public and in the media talking about how individuals can help us contain and conquer this virus.
"I believe my personal experience with being self-quarantined will make me a better communicator. Being quarantined for 14 days in May was certainly no fun, but because we at FDA were already functioning very effectively virtually, I was able to continue to be fully engaged, and provide direction and leadership. And it made me even more focused on making sure consumers have all the information they need about self-protection.
"We now need to look forward. A major strength of the FDA is not just in our response to a crisis, but in our ability to learn from the work we do and apply that experience in the future.
"As this pandemic evolved, it was clear that some FDA processes needed to be adjusted to accommodate the urgency of the pandemic. I think the entire FDA team has now seen first-hand that we need to look at some of our processes and policies. I have instructed my staff to identify the lessons learned from this pandemic and what adjustments may be needed, not just to manage this or future emergencies, but to make FDA itself more efficient in carrying out our regulatory responsibilities.
"I am committed to making sure that some of the lessons learned from managing this pandemic will lead to permanent improvements at the FDA in processes and policies.
"For example, in facilitating the development of new treatments, we streamlined some of our processes.
"We have taken a fresh look at how clinical trials should be designed and conducted. In a pandemic we knew we needed to get answers more quickly. For instance, early on, the FDA, National Institutes of Health, and industry worked together to facilitate the implementation of a “master protocol” that can be used in multiple clinical trials and allows for the study of more than one promising new drug for COVID-19 at a time. And we have used expanded access to meet the needs of patients who are not eligible or who are unable to participate in randomized clinical trials.
"Many of the permanent changes that we will implement really represent an acceleration of where we were headed before. For example, the concept of decentralized clinical trials, in which trial procedures are conducted near the patient’s home and through use of local health care providers or local laboratories has been discussed before, and laid the foundation for some of the trials for COVID-19 products.
"Another area where our pre-COVID work has informed our response to the pandemic involves the use of Real World Evidence (RWE).
In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data—such as data from electronic health records, insurance claims, patient registries and lab results.
"As the pandemic brought an urgency to these efforts, the FDA advanced collaborations with public and private partners to collect and analyze a variety of real-world data sources, using our Sentinel system and other resources.
"Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity, and use available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19. The more experience we have with real world evidence, the more confidence we will have in using it for product decisions.
"I mention real world evidence, but in reality, we have so many examples of how lessons learned from the pandemic will affect FDA in the future.
"To the extent that the innovations and adaptations we implemented during the pandemic crisis worked and would be appropriate to implement outside of a pandemic situation, we will incorporate them into standard FDA procedures. And to the extent that we identified unnecessary barriers, we will remove them. This is one of my top priorities. Permanent change where needed will take place, and will make FDA an even stronger agency.
"As I mentioned before, anything that enables quicker reviews and authorizations we will seek to make permanent.
"But make no mistake. We will not cut corners on safety or effectiveness. I said this before, and I say it again. Good science as the basis for decision making has been a hallmark of my career, and is a value that I hold deeply. The American public must have confidence in the products regulated by the FDA.
"Speed is important, but so are safety, accuracy and effectiveness.
"FDA’s commitment to good science and rigorous data is unwavering, even as we look at how we can learn from this pandemic.
"I am hopeful that this is a once-in-a-lifetime experience for all of us. An unprecedented historic event that has required an unprecedented response from us and everyone around the world.
"That said, I am pleased that throughout this crisis the rest of the FDA’s work has continued, with relatively few interruptions. New drugs and devices have been authorized. Our food safety surveillance has adapted and our outbreak response resources have been maintained. Our oversight of tobacco products, including e-cigarettes, has gone on. The Agency has measured up to the challenge in all ways.
"And we are well positioned as we move into a new phase, that is, transitioning back to what has come to be known as the “new normal.” Our staff has done a phenomenal job of adapting to this new normal. And I am confident that they are ready to deal with any additional upcoming challenges.
"I will close with something I’ve seen reaffirmed time and time again over the past few months. That is the essential role that the FDA plays in consumer protection and beyond in advancing public health.
"Before coming to the FDA, I had heard about the extraordinary dedication of the agency’s workforce. Working side by side with my colleagues in response to this pandemic, I’ve seen that characterization validated over and over.
"It is my great honor to serve with so many highly skilled and committed professionals. And the American people can be assured that this agency is working around the clock for them, doing whatever is necessary to fulfill our mission to protect and promote the health of the American public.
"I encourage you all to stay safe, aware, and focused as we continue to respond to the challenges of this public health emergency."