Remarks by the Commissioner of Food and Drugs

Robert M. Califf, MD
Food And Drug Law Institute Annual Conference
May 15, 2024

ABSTRACT

Remarks made during Fireside Chat, moderated by Vernessa T. Pollard, Partner, DLA Piper LLP and Vice-Chair, FDLI Board of Directors

Pollard: [F]ood safety issues have sort of been at the forefront of the media and FDA’s focus; specifically, FDA’s proposal for a unified food program and the new ORA model has received a lot of attention in the media. We’d love to hear from you about how far the changes that have been implemented have gone to respond to the Reagan-Udall Foundation report that proposed some changes to FDA’s food safety
program.

Califf: Great, and you know the more this can be like a conversation the better for me. I could filibuster for thirty minutes, but I’ll try not to do that. First point to make is, you mention the Reagan-Udall report. It was a very important moment—as you may remember, my first day of confirmation was the day of the Abbott recall, and so, it was quite a welcome back to the FDA—and there were obviously a lot of issues that I knew about from my previous stint at FDA. I think the food program has been vastly underfunded for a long time, and it had a structure which was not amenable to crisp decision making. And so it was really good to get the Reagan-Udall Foundation to put together a panel, listen to all the internal issues and thoughts, but also get a good survey of what people outside the FDA thought. We were really lucky that Jim Jones, who was on that panel, decided to apply for the job, and I can’t tell you how good it’s been to have Jim in that role. There’s also a lesson there, I think, for organizations. I’m one who typically thinks that structure is much less important than people. But this is a case, as evidenced by what’s going on with avian influenza, where the structure really was an impediment. Because we had great people in every part of the system, but the system was set up—it was almost like it was on purpose to make it impossible to come to a crisp decision—and, although it’s correct to say that we still have a proposed reorganization, because we can’t implement until we get all the way through the executive branch, the Congress, and then make sure we’re at peace with the unions on where we’re headed, hiring Jim and creating a decision making structure has really, I think, made it relatively easy for us to come to good conclusions as we’re dealing with this very complicated, multi-departmental cross-government One Health issue with avian influenza.