Remarks by the Commissioner of Food and Drugs

Robert M. Califf, MD
Food And Drug Law Institute Annual Conference
JUNE 14, 2022

Good morning. I’m delighted to be with you again, albeit virtually, for this important conference. It’s just one of the bonuses of my being back at the FDA.

I will tell you that more than a few people have asked me why I might want, at age 70, to immerse myself again in the stress and anxiety produced by Washington policy, personnel issues, and congressional funding battles, not to mention the regular demands and responsibilities of the FDA, which on a good day is pretty tough, let alone when we’re responding to a pandemic or working around the clock to increase the supply of infant formula and distribute it equitably.

I would have been quite happy continuing my life in the private sector, living near the Golden Gate Bridge, being with my grandchildren, and having plenty of time to focus on my love for sports like Duke basketball and golf.
And yet, here I am, talking with a bunch of attorneys and other experts on FDA law. I returned to FDA because we are at pivotal moment—for our nation’s public health, for the future of our contribution as a nation to global health, and for the future effectiveness of the FDA.

Developments in science, medicine, agriculture, and technology have created enormous opportunities to help make the American public safer in each of the areas we regulate—from the development of new treatments and cures for disease, to new ways to make our food supply safer, to the chance to further limit the dangers posed by tobacco products and opioids, to name just a few. But to do so requires us to respond to challenges that go to the very essence of our agency.

I already was aware of many of these from my earlier experience at FDA. Indeed, as I was preparing for, and going through my confirmation hearings, I heard from many well-informed people about how the FDA needs to address its persistent lack of resources, an outdated organizational structure, and a profound need for data, technological and informational modernization, to name just some of the challenges.

I want to be clear that acknowledging these needs is not in any way an indication that the agency is not doing what it needs to do to protect the public. One of my greatest pleasures in returning to the FDA is the opportunity to work with a world class workforce that does an amazing job and is completely committed to the mission and the work it engenders.

It is, however, a recognition of changes that are needed to support the human effort required to keep up with, or really, to stay ahead of, the industries we regulate, and the technology, science, and communications those industries employ.

I am old enough now to say this with some confidence: After years of working in both the public and private sector, I believe that success follows proper attention to structure, function, leadership, and resources that support the people who do the work—in this case our FDA workforce. The tendency in Washington is too often to point only to leadership, a foundational requirement for sure, but not enough by itself. In the almost four months since being confirmed, I’ve focused on a number of priorities that address these needs, and that cut across the agency and the breadth of our responsibilities.