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A Perspective on the FDA’s COVID-19 Response

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6 photos: FDA Commissioned Corps officers donning protecting gowns, gloves, masks and visors; 3D illustration of the coronavirus; cotton facemask; physician wearing medical gloves drawing vaccine or antiviral drug from vial with a syringe; closeup of blood in beaker labeled COVID-19 Positive; closeup of scientist preparing to examine sample under microscope

By: Mitch Zeller, Director, FDA Center for Tobacco Products

I have the honor to run the FDA’s Center for Tobacco Products (CTP). While CTP’s work to protect the public health is essential and continues during the pandemic, we are the least involved of the FDA centers when it comes to working directly on the coronavirus (COVID-19) response. That said, I’ve been proud to join my FDA colleagues in our “all-hands-on-deck” approach to tackling this pandemic, lending as much support as possible as my FDA colleagues across the entire organization work tirelessly for the American people. 

The COVID-19 pandemic represents a new and significant challenge for all of us – both personally and professionally. Despite these challenges and the impact on all of us, I am hopeful and inspired by what I see happening behind the scenes at the agency. 

I’d like to offer my own perspective, from where I sit, on how the FDA is battling this pandemic. The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response. As we proactively partner in new ways with our sister agencies and external partners, we are becoming more nimble, while maintaining our unwavering commitment to protecting the health of the American people. We continue to address any and all challenges that arise during this public health emergency including, for example, ensuring a safe food supply for humans and animals, working hard to facilitate access to diagnostics and moving forward the development of treatments and vaccines. 

Dr. Mitch Zeller
Mitch Zeller

I am privileged as a Center Director to see the hard work behind the scenes at the FDA. But I am keenly aware that the scope of the agency’s thoughtful deliberations is not always evident to external audiences. Nor, as regulators whose job it is to always follow the science, do our decisions always satisfy the broad array of external stakeholders. Those of us who work in CTP know what it’s like to be in the spotlight. Most recently, the distressing incidents of severe respiratory illness associated with use of vaping products, and the rise of youth use of e-cigarettes, put our work front and center. Yet regardless of the issue confronting the agency, the FDA team never loses sight of the need for science-based approaches to achieve an outcome that is most protective of public health. I can tell you how reassuring – and truly remarkable – it is to see the prolonged intense effort, attention and expertise the FDA is putting into the pandemic response. 

For almost 40 years I’ve worked on FDA issues – as a public interest attorney, Congressional oversight counsel, foundation executive, consultant – and now for the last seven plus years in my second stint as an agency official. I’ve seen the FDA at its best, responding to unprecedented emergencies such as HIV/AIDS with both zeal and creativity. While the agency’s work on HIV/AIDS was a hallmark of compassion and commitment, what strikes me as being so imperative is that the agency remains steadfast in ensuring new diagnostics and therapies are safe and effective at all times – even in a pandemic. 

The FDA I see today is clearly making a big difference, with thousands of highly-qualified staff and a team of dedicated, exemplary leaders working around the clock on the agency’s response. They are addressing every aspect of the crisis, from diagnostics to therapeutics to food safety and everything in between. The leaders at the FDA, starting at the top with Commissioner Hahn, represent the finest in public spirit and public service. 

My peers on the leadership team are working nonstop with support from the most talented group of experts I have ever seen address a public health crisis at the FDA. My colleagues never lose sight of the need to move quickly and boldly yet are always mindful of the public health standards we are obligated to uphold in our statute. They are using every available method to move new treatments to patients as quickly as possible, while at the same time continuing to use a science-based, data-driven approach to determine whether they are helpful or harmful. The recent establishment of the Coronavirus Treatment Acceleration Program and its many features provide just one example of how the agency is employing rapid, interactive response efforts.

I also see how agency leadership is making sure to protect the safety of the FDA workforce. In the multiple conference calls I participate in every day as part of the outbreak response, FDA leaders continue to stress that the safety and well-being of staff is critical. In addition to maximizing telework, we have provided several flexibilities to our staff and significantly reduced the number of employees reporting to our campuses and buildings. And for those employees who are performing critical functions that cannot be done remotely, we are working to keep them as safe as possible. Our employees are our greatest asset and they never cease to amaze me with their steadfast dedication to our mission.

Going forward, we will be forever changed as citizens by what this pandemic has wrought. Personally, this will bring new perspective on what is important and essential in our lives, as we collectively and individually confront the pandemic’s life-changing impact. Professionally, we will find the time to assess the vital role we play as regulators. What should we do differently? What bedrock principles of consumer protection should remain unchanged? However we answer these questions, I am humbled and encouraged to know that the FDA has a strong, committed team that will continue to fulfill our critical public health mission that the American public counts so much on us to perform. 

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