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Speech | Virtual

Event Title
Dr. Hahn's remarks to the Alliance for Health Policy Brazda Breakfast Briefing
January 8, 2021

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


(Remarks as prepared for delivery)

Good morning and happy new year.  Thank you, Dr. Tuckson, for that kind introduction.  And thanks to the Alliance for Health Policy for hosting me today at the Brazda Breakfast series.  It’s an honor to be a part of this long tradition of important and rigorous discussions on public policy and public health.   

As always, the new year brings with it a healthy dose of optimism and hope for new beginnings.  This year, I believe this promise arrives with some tangible developments, in the form of scientific advances to help bring the COVID-19 pandemic under control.

Over the past year, our nation has confronted extraordinary challenges and pain.  Communities and families have faced turmoil and tragedy, and we’ve seen extraordinary examples of courage and resolve.   

The FDA has been in the center of the efforts to combat this public health emergency, and it too has faced professional and personal challenges. 

We have worked to meet these challenges with unprecedented scientific effort and diligence.  

The Agency’s workload increased significantly to meet the extraordinary demands of COVID-19, and our workforce responded in kind, taking on these new challenges while continuing to fulfill our regular, mission-critical responsibilities.  I’d like to address both aspects of this commitment, and I’ll start by giving you just a small sampling of some of our non-COVID- related achievements.

Our foods team worked diligently to address food supply issues during this crisis and to support employees and employers in COVID-affected food industries resume operations safely.  At the same time they also advanced some important initiatives related to food safety generally. 

In July, we announced the release of the New Era of Smarter Food Safety Blueprint, which outlines the steps the FDA will take over the next decade to create a more digital, traceable and safer food system.

And we released the 2020 Leafy Greens STEC Action plan to outline a collaborative, action-oriented approach to enhancing the safety of leafy greens and help prevent the recurring nature of outbreaks of Shiga-toxin producing E. coli.

Our Center for Veterinary Medicine (CVM) made history with the approval of the first animal biotechnology product for both food and biomedical use, a milestone for scientific innovation.
CVM also approved 28 other pioneer and generic drugs, including several products to treat, manage or prevent serious diseases in animals, and provided important guidance to animal drug sponsors, promoting innovation to facilitate the development of new animal drugs.

Our Center for Tobacco Products has continued its science-based approach to regulating an evolving tobacco landscape and protect the public – especially kids – from the harms associated with tobacco product use.  This year, we issued the final rule requiring new health warnings on cigarette packages and in cigarette advertisements, which, when implemented, will be the most significant changes to cigarette labels in more than 35 years.

CTP also continues to address the alarming increase in the use of e-cigarettes among our youth, marking a milestone this fall with the premarket review submission deadline for certain deemed tobacco products, including e-cigarettes.  And they have taken numerous  compliance actions against products targeted to young people.

Our Office of Regulatory Affairs continued to work with states and the CDC to investigate the thousands of lung injuries and multiple deaths associated with vaping.  And they continue the multi-year effort to revitalize FDA’s laboratories nationwide, which are a cornerstone of the FDA’s scientific and investigative work.  

We’ve been very active on the inspection front, resuming prioritized domestic surveillance inspections in July. To ensure the safety of our workers and the health of the public, we’re taking a look at our inspection process to find new ways to optimize inspection-related activities, and exploring how to best use new technologies and tools during the pandemic, including a pilot program that is assessing the use of live and recorded video.

We expanded our working relationship with the U.S. Customs and Border Protection (CBP), and the U.S. Immigration and Customs Enforcement, Homeland Security Investigations with a new memorandum of understanding that will allow our agencies to maximize inspections, investigations and detection capabilities to prevent harmful medical products as well as other illicit prescription drugs, cosmetics and foods from entering the U.S market at our nation’s International Mail Facilities (or IMFs) and Ports of Entry.

We also made important strides in preventing the distribution of fraudulent COVID-related products to consumers, including unproven medical products, illegitimate test kits, and substandard or counterfeit respirators being offered for sale on the internet. 

In March, the FDA launched Operation Quack Hack, which to date has identified more than 1100 fraudulent and unproven medical products related to COVID-19. The Operation Quack Hack team has reviewed thousands of websites, social media posts, and online marketplace listings, resulting in the issuance of warning letters, and numerous reports sent to online marketplaces and abuse complaints to domain registrars, leading to the investigation and taking down of numerous websites illegally selling unproven products and retailers to remove hundreds of unlawful products from the marketplace.  Another effort, called “Operation Dirty Hands,” increased screening of potentially adulterated shipments of sanitizers.

All of this is in addition to the normal enforcement efforts by our Office of Criminal Investigations, which last year initiated more than 600 criminal investigations targeting violations of the law related to FDA-regulated products. 

Our medical product centers have been focused on addressing the challenges of this public health emergency. At the same time, they have continued to fulfill their normal responsibilities.

Last year, for example, CDER approved 53 novel drugs, as well as many new uses for already FDA-approved drugs to treat a wide range of medical conditions, including infectious, neurological, cardiovascular, endocrine, and autoimmune diseases, and cancers.  More than half of these approvals will help patients with rare diseases, many for which there was no previous FDA-approved treatment.

We also continued our important work to ensure access to cost saving drugs and needed medications, approving or tentatively approving more than 800 generic drugs, including 65 first generics.

Our Center for Devices and Radiological Health had a busy year supporting the agency’s response to COVID-19, playing a key role in the authorization of diagnostic tests, personal protective equipment, ventilators, and other devices to respond to the pandemic, and helping to address shortages in many areas.

In addition, outside of COVID-19, CDRH permitted marketing of more than 100 novel medical devices, such as the first cardiac ultrasound software that uses artificial intelligence to guide the user to capture quality diagnostic images.

This year also saw CDRH launch the Digital Health Center of Excellence, an important step in furthering the agency’s overarching dedication to the advancement of digital health technology. 

And our Center for Biologics, in addition to its monumental work on the COVID-19 vaccines, approved many important biological products and kept the nation’s blood supply safe. 

I should also point out the remarkable achievement that the agency has maintained the same pace of meeting its goals on the review of applications for medical products during the pandemic relative to recent years. For instance, in FY20, we met most of our user fee goals for drugs by taking timely action on at least 90 percent of brand, generic, and biosimilar drug applications, even during the pandemic.

Although this sample represents just the tip of the iceberg of our achievements, you can see why I am enormously proud of the contributions the entire FDA workforce has made, and continues to make, on many different fronts.

Of course, there is also an enormous additional amount of essential work being done in response to the SARS-CoV-2 virus.

From expediting access to COVID-19 medical countermeasures for the detection, protection against, and treatment of COVID-19 … to supporting the stability and quality of medical product and food supply chains … to ensuring that the Agency’s decisions are guided firmly by science through an open and transparent process, the staff has demonstrated an unwavering commitment to public health. 

They have helped provide answers to a nation eager for them, as well as confidence and trust in the products we have authorized or approved to treat the disease that is the cause of our national fears and anxieties.

The most recent significant development, of course, is our Emergency Use Authorizations (EUAs) of the Pfizer-BioNTech and Moderna COVID-19 vaccines, with other candidate vaccines in development .  While moving those authorizations across the finish line – in record time – is an amazing feat in and of itself, it’s important to underscore that these EUAs were the result of months of hard work and planning followed by careful and thorough scientific review.

Thanks to guidances we issued on the development, licensure, and Emergency Use Authorization of COVID-19 vaccines, developers had a clear roadmap of what data and information would be needed to facilitate the best and fastest outcomes, laying the groundwork for the authorizations.  What this meant was that we were able to help make these vaccines available to the public months before they otherwise might have been available.

And, of course, we continue to monitor the safety of these vaccines post-authorization, working with the U.S. Centers for Disease Control and Prevention (CDC) and other federal agencies involved in healthcare delivery – in partnership with health systems, academic centers, and private sector partners – to rapidly detect safety problems, if they exist. It’s all part of our continuing role in ensuring public trust and confidence that these vaccines, and all FDA approved and authorized products, meet our rigorous standards for safety and effectiveness.  

But vaccines are just one of the many essential medical products and processes we have approved and authorized in our response to COVID-19.

I certainly don’t have time to list all of these achievements, but it’s important to highlight just a few numbers that help demonstrate how we have worked in collaboration with, and in support of stakeholders, industry, and medical product developers to provide solutions to these medical challenges, speed the development process, and enhance public understanding of the virus and how to defeat it.

Since the start of the pandemic, we’ve reviewed over 700 EUA requests and issued over 300 EUAs for medical countermeasures, including therapeutics, vaccines, tests, PPE, ventilators and other devices to address patients’ needs in preventing, diagnosing and treating COVID-19. 

We have reviewed nearly 400 COVID-19 therapeutic candidates and 25 Investigational New Drug applications for vaccines to COVID-19; and issued hundreds  of warning letters to companies to enforce the safety and quality of products regulated by the agency, including medical products, foods, and veterinary products.

And we have published and revised more than 65 industry guidance documents related to COVID-19, to provide regulatory clarity on matters including clinical trial conduct, food safety inspections, and vaccine development.

In all this, we’ve stayed true to our mission to embrace the most rigorous science and best available data in the protection and promotion of the health and safety of the American public.

I should add that this is a responsibility for which we are uniquely prepared. The FDA has an arsenal of tools, resources, and expertise that provide us not just with the responsibility, but the flexibility and capability to respond to public health emergencies like this one. 

A hallmark of being prepared is to regularly evaluate experiences and apply lessons learned, both from previous public health crises and other responsibilities.   The FDA regularly reviews our actions, and develops and considers alternative approaches to achieve the best possible public health goals under our current authorities.

From the beginning of this crisis, we have worked to become more nimble in our regulatory response, streamlining processes to make it easier for developers and scientists to send inquiries and requests, provide greater clarity, transparency, and regulatory flexibility on topics ranging from diagnostics to the conduct of clinical trials, and moving as quickly and safely as possible to support medical developments.

We continue to reexamine the design and conduct of clinical trials, including important progress on our continuing efforts to increase the diversity of participants.

And we continue to expand the data sources that are used in the evaluation of medical products, including increased application and use of real-world data in virtually everything we do, including supporting our understanding of how COVID-19 is affecting patients and helping us advise product developers on how to optimize the design of clinical trials.

In furtherance of our efforts to build on what we have learned during this crisis, last April, we initiated the Pandemic Recovery and Preparedness Plan (PREPP), with a formal launch in August. 

We engaged a third-party expert in pandemic preparedness, for an independent, objective review of the Agency’s response thus far, to provide recommendations for potential action and approaches to sustain the agency’s response and build resilience.

Next week, to further our commitment to transparency and continuous learning guided by science, FDA plans to release a written report on the initiative that focuses on identifying opportunities to strengthen our on-going COVID-19 response and build the Agency’s resilience to respond to future public health emergencies. Following that, the Agency’s programs will review the recommendations to determine which actions to prioritize and the best path forward.

As you can see, the FDA has been very busy, and we have made enormous progress. 

We still have a way to go before we can put this emergency in the rear-view window, and, until then, we need to remain vigilant and safe.  But as I said at the outset today, I am confident that this new year brings not just hope, but new answers, new opportunities, and a renewed commitment to public health.

When I came to the FDA a little over a year ago, I eagerly anticipated the opportunity to immerse myself in an Agency that at its core is a science-based, learning organization.  I was not disappointed.

I am confident that the FDA will continue along this path, continually growing and learning, in behalf of its mission to protect the health and safety of the American public. 

Thank you, and I look forward to your questions. 

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