(Remarks as prepared for delivery)

Good morning everyone. First off, thank you to the Alliance for Health Policy for the invitation to meet with all of you today during a virtual Brazda Breakfast. It’s a privilege to represent the Agency and share FDA’s work to support the federal government’s response to COVID-19.

Over the past four years, I’ve had the privilege of serving in multiple leadership roles across the Department of Health and Human Services, including at the Centers for Medicare & Medicaid Services. As an oncologist, I also continue to care for patients with cancer at the National Institutes of Health.

At the beginning of the New Year, I joined Commissioner Hahn at the FDA as the Deputy Commissioner for Medical and Scientific Affairs. In this role, I lead the FDA’s operations as it relates to medical and scientific policy. I’m responsible for developing and leading high-priority FDA policy initiatives and oversee cross-agency teams in support of FDA’s public health mission. I’ve spearheaded Commissioner Hahn’s agency-wide strategic planning process and have led a number of initiatives during the COVID-19 pandemic, including our new Pandemic Recovery and Preparedness Plan (or PREPP) which we’ll discuss this morning.

I know all of you have been living through this crisis, and your coverage of the pandemic has been absolutely critical for keeping the public informed about the latest public health evidence. I hope to contextualize and share my perspective about FDA’s response  over the past several months. Specifically, I’d like to share about the policies and programs which FDA has initiated during COVID-19, and offer insight into how the Agency intends to identify lessons learned from the pandemic to modernize and strengthen the FDA.

First, I’d like to start by charting the evolution of the pandemic in the United States.

The first case of COVID-19 in the U.S. was reported on January 20, 2020. Seven days later, FDA announced key actions to advance the development of novel coronavirus medical countermeasures.  This preparation enabled us to take rapid action after Secretary Azar declared a public health emergency one week later. For example, when the Agency received the first submission of an Emergency Use Authorization (or EUA) for a COVID-19 diagnostic test, FDA was prepared and was able to complete its review within 24 hours.

Over the past six months, as we all know too well, the novel coronavirus has spread exponentially across the U.S. and the world, causing significant disruption to normal life and levying a substantial impact on human health. As a novel pathogen, the medical community has had to adapt in real-time to identify the best method to detect, treat, and protect patients from this highly transmissible and dangerous virus. FDA has played a critical role in supporting front line providers as well as the federal government’s response.

One thing that emerged from the early days of the pandemic is that the public lacked clear understanding of the roles of the various public health agencies. As you all know, FDA’s role differs from that of other federal agencies.

The Agency does not sponsor  clinical trials like the NIH, nor does the Agency develop tests like the CDC, nor does the Agency invest in companies to accelerate the development of medical countermeasures like BARDA. FDA is a regulator. As a regulator, FDA’s responsibility is to ensure the safety of consumers by rigorously evaluating the evidence about the benefits and risks of medical products.

It’s especially important for the public to understand FDA’s role as we enter into the next phase of testing of vaccines and as new drugs are being developed to treat COVID-19 patients.  I hope that your stories can help FDA clarify its role.

FDA has taken many actions to deliver on its public health mission throughout the pandemic. For example, FDA has sought to expedite the timely development of and access to medical products to accelerate the recovery from COVID-19. The Agency has also been committed to ensuring the safety of consumers, from proactively issuing communications about fraudulent products to providing regulatory guidance on issues ranging from grocery shopping to the medical supply chain.

Each action FDA has taken for COVID-19 is grounded in the Agency’s commitment to scientific integrity and regulatory independence, to deliver on our mission of protecting and promoting the public health.

One example is the Agency’s approach to expedite access to COVID-19 tests. Throughout the pandemic, FDA’s policies on tests has evolved in lockstep with the evolving public health need and the best available scientific evidence.

When the U.S. outbreak started in January, there were no established diagnostic tests because SARS-CoV-2 was a novel pathogen. To expedite access to diagnostics, FDA used its EUA authorities, which allow FDA to authorize the limited emergency use of promising medical countermeasures. FDA authorized the first diagnostic test, which was developed by CDC, on Feb 4th.

As the virus spread exponentially during March, we saw challenges with the rollout of CDC’s test in the public health labs, and had no other submissions for fully validated tests until Feb 29th. Thus, it was evident that additional FDA action was needed to meet the unprecedented demand by the public and medical community for COVID-19 diagnostic tests.

Consequently, we adapted our policies for COVID-19 tests and streamlined the EUA submission process. We posted and updated templates and guidance to help facilitate EUA requests from developers, as well as FDA’s review of these requests.

In addition to prioritizing access, FDA took a number of steps to create an infrastructure for validating test performance. In the case of molecular diagnostics, the Agency created a reference panel for developers to facilitate comparisons of test performance. Likewise, for serology tests, the Agency partnered with the National Cancer Institute to perform independent performance evaluations.

FDA’s proactive regulatory actions for COVID-19 tests have also promoted innovation in diagnostic technology. As of this week, the agency has issued EUAs for over 200 COVID-19 tests. These tests include molecular diagnostics and antibody tests. FDA has also issued EUAs for tests that use CRISPR gene editing technology, use self-collected specimens, and allow for the use of pooled strategies.  We’ve issued policies explaining under what circumstances FDA doesn’t intend to object to the use of certain tests prior to clearance or authorization. We constantly monitor these policies and throughout the course of the pandemic, we’ve updated them as the evidence and information available to the Agency has evolved.

Diagnostics, of course, are only one piece of the clinical puzzle. It’s also important that we help ensure providers have access to safe and effective medical products to treat patients.

As scientists began to investigate potential treatments for COVID-19, FDA sought to quickly focus its  resources to support the development of new therapies. To do so, in March we launched the Coronavirus Treatment Acceleration Program, or CTAP. 

This program has been innovative and has enabled us to triage all incoming requests and proposals for potential COVID-19 therapies. We’ve matched innovators with the appropriate scientific and technical experts within the Agency. There are many benefits to this program.

First, it helps improve coordination within the Agency and accelerate review timelines. Second, it helps improve communication with developers, and ensures they get the feedback they need to iterate and improve on protocol designs.

CTAP’s efforts have helped to significantly accelerate therapeutic development during the COVID-19 pandemic. More than 270 clinical trials have been initiated as of July 31, and over 570 additional clinical trials are in planning stages. The products under investigation include antivirals, immunomodulators, neutralizing antibodies, and more. FDA’s proactive approach has helped support a diverse pipeline of therapeutic candidates and, most importantly, improve patient access to investigational new drugs. CTAP offers important, early lessons for modernizing the clinical research process for the post-pandemic era.

I can’t predict which of the many candidate therapies will prove to be safe and effective. It’d be inappropriate for me or anyone at FDA to speculate, since we’re tasked with deciding which therapies ultimately are approved. However, I want to emphasize that FDA is prepared to review data on a real-time basis, and to render judgments with unprecedented speed, while at the same time apply the same standards for safety and efficacy that we apply to all therapeutics seeking FDA approval.

Progress to date on developing therapies is promising. For example, a randomized clinical trial led by the NIH found that remdesivir, an antiviral drug, accelerated the recovery of hospitalized COVID-19 patients. FDA was able to issue an EUA for remdesivir approximately 48 hours after receiving the preliminary trial data.

As the FDA reviews data and makes regulatory decisions, we remain very  close  with our federal partners.  For example, FDA’s rapid action on remdesivir helped enable the NIH to update its clinical guidelines for the treatment of COVID-19, and allowed HHS to develop an allocation and distribution plan to get remdesivir to patients in need.

A critical component of FDA’s response to COVID-19 has been the Agency’s commitment to ensuring the safety and effectiveness of potential COVID-19 vaccines.

It was clear from the beginning that a safe and effective vaccine for COVID-19 would be critical to help accelerate the world’s return to normal. This is why the federal government launched Operation Warp Speed at the beginning of the summer, which is a collaboration between HHS and the Department of Defense. Its purpose is to focus resources and investments for the development, testing, and manufacturing of medical countermeasures for COVID-19, of which vaccines are an essential part.

This focused effort is necessary because vaccine development is a resource-intensive endeavor that normally takes many years. But by investing funds upfront, the federal government is effectively de-risking the development process for innovators.

To be clear, the federal government’s efforts to fund vaccine development are completely independent of the FDA’s statutory responsibility to evaluate the safety and effectiveness of a vaccine. While the Agency has provided technical and regulatory guidance to Operation Warp Speed, the Agency does not play any role in OWS decision-making.

Commissioner Hahn has repeatedly affirmed FDA’s commitment to reviewing potential COVID-19 vaccines using the same, established, deliberative, and scientifically rigorous process which the Agency has always used when evaluating the safety and effectiveness of vaccines.

I want to reiterate that commitment this morning. 

One way we are keeping arm’s length from the current vaccine testing process is that we issued a guidance document on COVID-19 vaccines on June 30, in advance of the initiation of large-scale clinical trials. In this guidance, FDA clearly laid out the key considerations for evaluating a potential vaccine.

For example, the Agency recommends that developers make an effort to recruit older adults and minority patients for vaccine trials since the data on COVID-19  indicates that these populations have been the most vulnerable to infection and severe illness. Likewise, the Agency explicitly recommended that potential vaccines be at least 50% more effective than placebo in preventing COVID-19 infection in clinical trial participants. 

FDA believed that recommending a baseline for performance for COVID-19 vaccines was necessary to advance a transparent process and to reinforce confidence that broad distribution of a potential vaccine could offer immunity to the majority of the population.

Since FDA released this guidance, we’ve seen developers reach important milestones for vaccine development. Several developers have reported promising results from Phase 1 trials in July. And, as of this month, developers have begun to recruit and test vaccine candidates in large-scale Phase 3 trials, which will provide critical evidence about safety and effectiveness.

I can’t offer any insight as to when a vaccine might be available. As a regulator, FDA can only make decisions when the data are available for review, and at this time, trials remain underway.

But as Commissioner Hahn, Dr. Peter Marks, and I recently wrote in JAMA, when the results from trials become available, FDA will review them with the same scientific integrity and rigor that the Agency has used for the past century to ensure that potential vaccines are safe and effective for consumers.

I can once again reassure you that all of us at the FDA are committed to ensuring that all review processes are unbiased and transparent. That’s why we preemptively gave developers our recommendations for vaccine development so it’s clear what the standard for approval will be.

And given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA’s Vaccine Advisory Committee, prior to vaccine authorization or licensure, will help ensure public understanding of the evidence supporting safety and efficacy.

While all of us want the world to return to normal as quickly as possible, it’s imperative that we do this process credibly and transparently and that the public has confidence in our decisions. FDA is committed to its role as an independent arbiter of data and evidence, and we’ll continue to proactively communicate updates to you in the media and vis-a-vis you to the public.

Another category of medical products for COVID-19 is personal protective equipment, or PPE.

As both a practicing physician and a consumer following CDC recommendations for universal precautions, FDA’s efforts to accelerate access to quality PPE is particularly dear to me.

PPE includes many types of medical devices, including surgical respirators, gloves, gowns, and face shields.

The Agency’s actions for PPE during COVID-19 include helping facilitate availability through EUAs, providing regulatory flexibility, and collaborating with innovators to expedite development and manufacturing.

To help increase the availability of PPE, FDA has issued numerous EUAs. FDA also issued EUAs authorizing PPE decontamination systems so that certain PPE, including particular respirators, can be reused. We also simplified the import entry process for PPE products authorized in the EUAs, and provided outreach and instruction to importers to facilitate entry of these  products. The Agency also published conservation strategies for the reuse and preservation of certain types of PPE.

FDA remains committed to proactive outreach and partnerships with developers to help meet the increased demand for PPE. For example, we’ve issued several guidance documents for products, such as sterilizers, disinfectant devices, air purifiers, and gowns, that provide recommendations on what manufacturers should include in an EUA request.

Furthermore,  we’re working in partnership with the NIH, the VA , and America Makes to support non-traditional manufacturing approaches (e.g., 3D printing), to address device shortages including PPE. This effort so far has helped match over 300,000 face masks and 500,000 face shields with health care providers and others in need.

FDA is committed to ensuring the safety of consumers as well as our health care heroes on the frontlines throughout this pandemic. With respect to consumers, the Agency recognizes there may be bad actors seeking to take advantage of the significant public anxiety.

One concern has been the marketing of fraudulent and counterfeit medical products.

To help protect consumers from these products, FDA initiated Operation Quack Hack. This is a cross-agency effort led by FDA, in collaboration with CBP, the Federal Trade Commission, and the Department of Justice. The purpose of Operation Quack Hack is to proactively identify products making false COVID-19 claims and shield American consumers from the harm, both physical as well as financial, these unproven products may cause.

For example, the Agency has requested that online retailers be vigilant in identifying and removing  fraudulent COVID-19 products from their platforms. Likewise, the Agency works with technology companies to identify websites and social media posts selling unproven products with false or misleading COVID-19 claims.

To date, the Agency has identified over 1000 fraudulent medical products for COVID-19 and has issued more than 100 warning letters to companies selling unapproved, unauthorized or uncleared products. FDA also has worked with online marketplaces and domain name registrars so  they can investigate and remove from their platforms products that make fraudulent claims.

These efforts are an important part of the Agency’s efforts to help keep consumers healthy, safe, and informed during the pandemic.
While the pandemic is currently priority number one for FDA, work continues on many other public health initiatives. The Agency continues to review submissions of medical products while balancing the added workload of hundreds of additional COVID-19 related submissions.

FDA staff have risen to the occasion, and the Agency remains on target to meet our user fee goals for drugs this year by reviewing and taking timely action on at least 90% of branded, generic, and biosimilar human drug applications…even during the pandemic.

For example, the Oncology Center for Excellence (OCE) has facilitated the approval over 30 new cancer drugs, while balancing the increased workload of supporting patients and developers as they work to adapt clinical trials under the circumstances of COVID-19.
FDA has also continued its efforts to modernize its regulatory programs to keep pace with new innovations in health care.

A prominent example of this work is digital health.

FDA had previously launched a Digital Health Innovation Action Plan to develop a regulatory framework to support digital health innovation.

During COVID-19, the Agency issued a temporary policy to expand patient access to digital health therapies such as computerized behavioral health therapy to help Americans experiencing mental health challenges during quarantine. Furthermore, FDA exercised enforcement discretion for remote monitoring devices (such as blood pressure cuffs) to support patients’ abilities to manage their chronic diseases during the pandemic. During this pandemic, FDA also approved another digital health therapeutic to support children with ADHD.

The Agency has also continued its efforts to reduce the risk of foodborne illness, unveiling  a blueprint for A New Era for Smarter Food Safety earlier this summer.

Together with the Food Safety Modernization Act, this blueprint seeks to move the nation’s food production closer to achieving an Integrated Food Safety System. The New Era blueprint represents a new approach to food safety, leveraging technology and other tools to create a more digital, more traceable, and safer food system.

These examples are just a few of the numerous work streams that have continued during COVID-19.

The entire FDA staff have measured up to this pandemic and have continued to provide the level of innovation and integrity that the public has come to expect.

Finally, as the pandemic has progressed, it’s become very clear that the Agency’s response to COVID-19 can offer important lessons for both improving FDA’s emergency response and strengthening overall operations.

One of Commissioner Hahn’s major priorities is to use the lessons learned from the COVID-19 experience to examine FDA processes and modernize and update them where needed. 

He’s asked me to lead this cross-agency effort.      

For example, I mentioned earlier CTAP, our special emergency program launched to aid medical product developers in preparing high-quality submissions and streamline their regulatory review. The program uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful. This fit-for-purpose program for COVID-19 treatment may offer important lessons for how the Agency can continue to modernize the clinical trial process.

To formalize this program of reviewing FDA’s response and identifying lessons learned, Commissioner Hahn launched the COVID-19 Pandemic Recovery and Preparedness Plan (or PREPP) imitative in early August.

Its goal is to identify durable improvements in policy, process, and program operations to both accelerate the recovery from COVID-19 as well as strengthen the agency’s preparedness for future emergencies.

In terms of process, PREPP will occur in three phases.

First, the Agency will interview key staff and solicit feedback from stakeholders. Second, we’ll synthesize lessons learned to identify key priority areas for change. Lastly, we’ll develop an implementation plan for introducing improvements and modernization to regulatory processes, operations and communications, and intra-agency coordination.

As part of our review, PREPP will examine the Agency’s capacity to collect, share, and utilize data, and identify opportunities to build on the foundation that FDA has developed to improve regulatory decision-making.

Another key element of the review will be regulatory science. In other words, what options does the Agency have to support innovation and protect consumers within its regulatory authorities?

For example, lessons from EUAs for COVID-19 diagnostic tests can provide important insight as to where gaps and flexibilities in FDA regulation might be.

FDA has always been committed to continuous improvement, and PREPP is directly grounded in the Agency’s longstanding commitment to leadership and scientific excellence. The lessons we learn in this once-in-a-lifetime crisis can strengthen the FDA for generations to come.

Let me conclude by saying that I really appreciate the opportunity to meet with you today.

During my time in the Federal government, I’ve gained a deep respect for the vital role of the media in communicating with the public, and in keeping us focused on the issues that most impact American consumers.

Our intention at FDA is to continue to build our relationships with you because we recognize the importance of dialogue and conveying accurate and reliable information, a responsibility that has only been heightened during this pandemic.  

I really look forward to our discussion today. Thank you.