August 12, 2020 — As healthcare providers and essential personnel work on the front lines of the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) wants clinicians to know that it is here to help through this critical time. Below is a preview of the latest recorded remarks given by FDA Commissioner, Stephen Hahn, M.D. You can watch his speech on YouTube here: https://bit.ly/30Nz8Kj.
"I’m pleased to have the opportunity today to speak with you about COVID-19, the FDA’s role in responding to this public health emergency, and the continuing challenges the agency and the medical profession face as it continues to evolve.
"I’d like to begin by thanking Dr. Susan Bailey and the American Medical Association for hosting and moderating this event today, as well as the Reagan Udall Foundation for their continuing support of the FDA.
"And I’d like to thank all of the physicians and health care professionals on this call today for your hard work, thoughtfulness, and commitment during this challenging time. Among the heroes who have emerged from this crisis are the health care professionals who have risked their own health to serve their patients. The nation is indebted to you.
"As we move forward, we know that the pandemic continues to evolve and the health care community must continue to deliver high-quality care to all patients.
"Fortunately, we’ve made significant progress in our understanding of this disease, our ability to combat it, and our efforts to help patients suffering with it.
"As health care professionals and scientists, we understand there are no easy answers. We still have much more to learn about this disease, with many unanswered questions. And we need to not only treat patients with the disease, but also to prevent the spread of the disease as we seek effective therapeutics and safe and effective vaccines.
"Today, I want to talk to you about some of these challenges and about the nature and importance of science and data as we search for answers.
"I also want to speak with you in your role as doctors and other health professionals, who are dealing with very practical questions involving patients – an experience I understand and empathize with from my own practice as an oncologist.
"Most importantly, I want to reassure you that the decisions that FDA will have to make in the coming months, with regard to new tests for COVID-19, new therapeutics, and new vaccines, will be based on good science and sound data.
"Because of the speed with which we need to make decisions, there has been discussion about whether FDA will compromise any of our scientific principles in reviewing data and making decisions about new products. Let me assure you that we will not cut corners.
"All of our decisions will continue to be based on good science and the same careful, deliberative processes which we have always used when reviewing medical products.
"It is important that you as medical practitioners not only understand this commitment, but also that you reassure your patients.
"We have seen surveys reporting that significant percentages of the public would be reluctant to take a vaccine once available. We hope that you will urge your patients to take an approved vaccine so that we can seek to establish widespread immunity.
"We can emerge from this emergency only by working together.
"We know that the overwhelming quantities of COVID-19 information and data that seem continually to be expanding can place a significant burden on you as clinicians seeking to respond to patient questions and, when appropriate, modify treatment recommendations.
"Indeed, COVID-19 is affecting the practice of medicine in many ways, and the FDA has an important role to play in supporting providers and patients through this evolution.
"Although it seems as if we’ve been engaged in the battle against COVID-19 for a very long time, in the broader context of disease and science, it’s actually been a relatively short period.
"Consider that as recently as this January – just eight months ago – few people, other than a limited group of health care professionals and infectious disease experts, had even heard of the novel coronavirus.
"It’s easy for me to recall just how recently SARS-CoV-2 appeared on our national radar. That’s because the first reports of the outbreak began just a few weeks after I was sworn in as FDA commissioner. I’d like to share with you my own experiences and what I have learned in the past six months.
"From the very beginning, this has been a perplexing and challenging medical mystery, presenting far more questions than answers. Even for those who have followed this public health crisis from its earliest days, little information or understanding of the disease was available.
"We didn’t know, for instance, basic things, such as how aggressive, virulent, or contagious the virus was.
"That’s not a comfortable position for health professionals who like to be well informed, particularly when we work at agencies charged with protecting the American public.
"I learned quickly that despite the relative lack of knowledge, we at the FDA had to make decisions about relative benefits and risks with the data we had.
"The FDA regulates the safety, effectiveness and quality of all medical products — drugs, vaccines, and medical devices. We also regulate food safety, which of course also is critical during a crisis like this.
"There is always a steep learning curve in the response to a public health emergency, particularly when it involves a new disease. But this learning curve has been especially steep for all of us.
"I am trained, as many of you are, as a scientist. And when this pandemic emerged, I conveyed to the leadership and staff at the FDA that even in the face of the public response to this emergency, we at the FDA needed to apply scientific rigor to any decisions being made, no matter how quickly they needed to be made,
"It was reassuring to me that the FDA leadership and staff agreed whole-heartedly with this approach. This is how the FDA has always functioned in its role as a federal agency that makes regulatory decisions based on scientific rigor.
"We at the FDA, and you as health care professionals have had to respond to challenges like these in real time.
"For this pandemic, in particular, for the FDA this has meant supporting the development of safe and effective medical countermeasures.
"These actions also included ensuring that our front-line health care workers had and will continue to have the necessary protective equipment.
"Since the beginning of this pandemic, FDA scientists have been immersed in providing essential regulatory advice, guidance, and technical assistance needed to advance the development of tests, therapies, and vaccines.
"And it’s meant that we have been vigilant in seeking to prevent the sale of fraudulent products that could harm the public.
"To be successful in each of these efforts, we’ve been working hard to strengthen the scientific response. We’ve done this by supporting collaborative efforts, creating open communication channels, and building public-private partnerships.
"For example, the FDA has created resources like reference-grade sequence data for SARS-CoV-2 to support research and reference panels for COVID-19 diagnostic tests to support continued developments in testing.
"The agency has supported the National Institutes of Health’s public-private partnership for therapeutic and vaccine development.
"The FDA has also partnered with a number of external partners to gather real world evidence to help inform our understanding of the natural history of COVID-19, drug utilization and performance of COVID-19 diagnostics and therapeutics.
"I’m pleased that so many of you — and the professional organizations you are part of — have been involved in some of these collaborative efforts.
"It’s essential that we bring forward the best ideas and innovations to support the development of new and effective treatments. Working together has been an instrumental part in our ability to come so far, so fast.
"Our approach is consistent with and, indeed, goes to the core of the FDA’s mission; we constantly gather new information and evidence about the disease to inform our actions.
"As we learn, we discover more answers. But that, in and of itself, is not enough. We must continue to be vigilant and aggressive, constantly reviewing and evaluating the data as they emerge.
"The principle underlying this — that our decisions must not only be informed by the most rigorous data and best science, but also that the evidence on which we base our continuing review is regularly refreshed and expanded through new experiences and opportunities — is a basic approach of science.
"It’s certainly a personal principle that has been a priority for me throughout my career as a physician and researcher.
"We are learning more every day. For example, as doctors have treated more cases of COVID, it has become clear that it is not just a respiratory ailment but can affect many organ systems, including the kidneys and heart, and can also cause vascular complications.
"And although initially, many of us believed children were not significantly affected by the COVID-19 virus, subsequent reports from across the United States and Europe showed that some young COVID patients were found to have Pediatric Multisystem Inflammatory Syndrome or PMIS.
"These cases exhibited clinical features similar to Kawasaki Disease, a rare inflammatory disease primarily affecting young children, which causes blood vessels to become inflamed or swollen throughout the body.
"Similarly, some dermatologists revealed that some of their patients who were later diagnosed with COVID-19 had symptoms that could be due to vasculitis, including frostbite like pain, small itchy eczema-like lesions on their extremities. and reddened patches of skin.
"We are all concerned about the reports of rising case counts in different locations across the U.S., particularly in the Sunbelt states.
"We have also learned that common sense public health measures such as the wearing of masks, social distancing, hand-washing, protection of the vulnerable, and avoidance of large indoor gatherings particularly in bars, do help stop the spread and mitigate community outbreaks. This is our country’s path forward.
"The emerging data also continue to confirm the disproportionate impact of the disease on different communities, based on age, ethnicity, and race.
"The Coronavirus Task Force, of which I am a member, continues to carefully analyze and monitor the prevalence of the virus throughout the U.S., using the best available science to track, predict and mitigate the curve of the outbreak. We are closely watching the entire country and working to determine the reason behind any new outbreaks or the spread of the disease.
"At the FDA, our work goes beyond analyzing the numbers. Our responsibilities involve a range of efforts relating to the diagnosis, response, and treatment of COVID-19 and supporting solutions to bring an end to this crisis.
"This includes facilitating the development of tests, both diagnostic and serologic, supporting the advance of treatments and vaccines for the disease, and working to ensure that health care workers and others have the personal protective equipment and other necessary medical products needed to combat it.
"Since day one of this emergency, our focus in addressing these challenges has been to meet the need for speed.
"To facilitate the development of new treatments and effective tests, and to make sure we have adequate supplies of essential medical equipment such as ventilators, we’ve redoubled our efforts to employ regulatory flexibility and streamlined processes where needed and appropriate, without compromising science.
"The goal has been to use every available tool in our arsenal to move new treatments to patients as quickly as possible while helping ensure safety and efficacy.
"We’re moving equally fast in our efforts to help support the development of COVID-19 vaccines.
"As this audience is well aware, preventive vaccines for infectious disease are foundational to modern public health.
"The FDA is committed to ensuring that potential vaccines for COVID-19 are safe and effective.
"In June, the agency issued a guidance outlining key recommendations for vaccine development.
"In particular, the agency emphasized the importance of recruiting diverse populations, especially those patients who have been disproportionately affected by the pandemic.
"The FDA also recommended in the guidance that sponsors use an endpoint estimate of at least 50%, which could have an important impact on individual and public health, while vaccines with lower efficacy might not.
"Several COVID-19 vaccine candidates have recently initiated large-scale clinical trials. While I cannot predict when the results from these studies will be ready, I can promise that when the data are available, the FDA will review them using its established, rigorous, and deliberative scientific review process.
"We all understand that only by engaging in an open review process and relying on good science and sound data can the public have confidence in the integrity of our decisions.
"One important tool we have used during public health emergencies to support the scientific investigation, is to employ our authority for Emergency Use Authorization (EUA).
"An EUA allows the use of unapproved medical products or unapproved uses of approved medical products to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain criteria are met, including that there are no adequate, approved, and available alternatives.
"These EUA decisions have been an important part of FDA’s efforts to shape an effective and timely response.
"Though EUA decisions are based on emerging scientific evidence, we are continually evaluating and reevaluating that evidence in order to ensure that the known and potential benefits of products outweigh the known and potential risks.
"Since the earliest days of the pandemic, we’ve issued EUAs for tests, ventilators, and drug treatments. The FDA has granted more than 190 EUAs for COVID-19 tests and has reviewed more than 200 clinical trials for potential therapies.
"Nevertheless, we understand that the pace of FDA announcements and decisions can cause confusion for the public and providers.
"For instance, some of you may be wondering whether an EUA changes the approach being used to develop drugs and vaccines. What should doctors tell their patients about what’s going on? What drugs are under development? Which are the safest or most effective?
"This is a good opportunity to reiterate that although EUAs may be made on this emergency basis, they are guided by science and by continuous review of the most recent up-to-date evidence available.
"Even after an EUA is issued, we regularly review that decision based on emerging information. We make any necessary changes as appropriate. This dynamic process is continually being informed by new data and evidence, and it always seeks to balance the risks with the benefits of every COVID-19 treatment.
"Take testing, for example. Since day one, tests have played a key role in the ability to understand and manage this disease. Good, accurate, and reliable tests can help reveal who has the disease or, by virtue of the antibodies in someone’s system, who has been infected with the virus.
"We’ve worked with hundreds of test developers, many of whom have submitted emergency use authorization requests to the FDA for tests that detect the virus or antibodies to it.
"In light of the circumstances, FDA’s goal has always been to provide the necessary regulatory flexibility to support developers and to provide what patients and the public need as quickly as possible without compromising safety or scientific review.
"Early on in this pandemic, the FDA posted a policy that explained that under certain circumstances, FDA did not intend to object to the use of tests that were developed and validated by laboratories prior to authorization of an EUA request. There was a national demand for such tests and we felt it was an appropriate decision to exercise regulatory flexibility concerning the use of these validated tests.
"It was soon evident that some of the self-validated tests were not reliable and FDA moved quickly to update the policy in response to the available information.
"Today, we have nearly 200 reliable, authorized tests. And we continue to monitor the performance of these tests and encourage the development of new and better tests that will enable us to understand this disease and help patients and the medical community address the challenges.
"As we have done since the beginning of the pandemic, we will continue to balance the pressing need for access to diagnostic and antibody tests with our helping to ensure that available tests are accurate and reliable.
"This same approach applies to potential treatments for COVID-19. We work closely with partners throughout the government, academia, and drug and vaccine developers to explore, expedite, and facilitate the development of products, and provide guidance and technical assistance to drug manufacturers to expedite clinical trials.
"Our Coronavirus Treatment Acceleration Program, or CTAP, which we launched in March, has helped to focus the scientific and technical expertise of the agency’s staff to review potential products according to their scientific merit.
"By providing enhanced regulatory support, the FDA has been able to support the initiation of more than 200 trials for COVID-19 therapies over the past few months.
"This work is essential to returning us to some semblance of normalcy. After all, we need treatments and cures.
"But there’s a corresponding aspect of the FDA’s work that is also essential.
"This role is to support you, as physicians and medical providers to help answer your patients’ questions. Certainly, explaining the process, as complicated as it is, is an important piece of the response.
"To understand this, it may be instructive to look at some actions we’ve taken with several drugs, each of which were granted an EUA, and that received significant public attention.
"Back in March, the FDA granted an EUA to allow the drugs chloroquine phosphate and hydroxychloroquine sulfate to be used to treat certain hospitalized COVID-19 patients when a clinical trial was unavailable, or when participation in a clinical trial was not feasible. Early but limited research indicated that the drugs, which are approved to treat malaria and have a well-understood safety profile, might be effective in treating COVID.
"After the EUA was issued, FDA continued to monitor the emerging clinical evidence on the use of these drugs in COVID-19 patients.
"Based on null results from randomized controlled trials and further analysis of clinical pharmacology information, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 in the patient population covered by the EUA and no longer met the legal criteria for emergency use. As a result, we revoked the EUA in June.
"Separately, the FDA issued an EUA for the antiviral drug remdesivir in May.
"A randomized trial led by the National Institutes of Health found that remdesivir helped to reduce the length of hospitalization for COVID-19 patients. Additional trials have been completed or are planned to help us understand the appropriate role for remdesivir in this COVID crisis.
"Because of the nature of the pandemic, there may be confusion or a lack of understanding about the actions we have taken on therapeutics.
"We rely on you in the medical community to answer patients’ inevitable questions about treatments and vaccine development. It is our responsibility at the FDA to provide you with the information you need for your patients.
"The fundamental message that we need to communicate is that the FDA’s decisions are based on science, that decisions sometimes change based on our careful review of the most recent evidence, and that we are committed to ensuring that the drugs we approve are safe and effective based on reliable data.
"Physicians and other health care professionals have other important roles and responsibilities. One they share with the FDA is to help ensure that the public gets the products they are being promised and to be aware of and avoid scams being perpetrated on them.
"The FDA regularly warns consumers to be cautious of websites and stores selling products with unproven claims to prevent, treat, diagnose or cure COVID-19 or unauthorized test kits. The FDA has not evaluated these fraudulent products for safety and effectiveness, and these products might actually be dangerous to patients.
"To help tackle the issue of health fraud during the pandemic, the FDA launched Operation Quack Hack, which monitors online marketplaces for fraudulent products and identifies misinformation about COVID-19.
"The agency has identified more than 700 fraudulent and unproven medical products related to COVID-19 and has collaborated with the Federal Trade Commission to issue warning letters to firms marketing products with misleading claims, and sent more than 150 reports to online marketplaces, and more than 250 abuse complaints to domain registrars to date.
"We make most of this information available on our website and encourage doctors to become familiar with this resource and share this information with their patients.
"Physicians have an important role in this area because of your ability to identify and track patients who take illegitimate or black-market drugs.
"There is currently no cure for the coronavirus, and it is important for doctors to help inform patients about dangerous products and unscrupulous marketers who may be selling products with false or misleading claims.
"Eight months into the pandemic, we have made important progress. Yet with cases continuing to rise, it is evident that further action is needed for our country to chart a course for recovery.
"The FDA is launching the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) to help apply best practices and lessons learned from the emergency response to date. Our goal is to make needed adjustments to support the ongoing COVID-19 response, while also strengthening our resilience and improving our capacity to respond to public health emergencies in the future.
"As doctors, we ensure that our treatment plans for our patients are adjusted according to the latest evidence.
"I believe this same principle applies to the FDA, which as a science-based agency, is committed to continuous improvement by examining the data and modernizing our approaches when needed.
"As we identify lessons and make subsequent changes, we are committed to proactively communicating any forthcoming regulatory changes to doctors and other health professionals.
"Though we don’t have all the answers, we do know is that the COVID-19 virus will be with us for the foreseeable future. We are still far from understanding every aspect of this disease.
"But the FDA will continue to operate with patient safety and scientific integrity as our North Star. It is this approach that continues to guide the development of new technologies and necessary regulations for safeguarding public health for the present and future.
"Our goal is to provide you with the information and understanding you need to ensure that patients receive the support, attention and treatment they deserve. We look forward to working with you to achieve that goal."