Remarks by the Commissioner of Food and Drugs

Robert M. Califf, MD
May 17, 2023
Food and Drug Law Institute 2023 Annual Conference

ABSTRACT

Good morning. I’m I pleased to have this opportunity to speak with you again. Few groups can match the level of experience and understanding of the work of the FDA as the Food and Drug Law Institute. While the FDA is a science-based organization with a profound public health mission, we are also, of course, a regulatory agency, and I’ve been reminded over and over in the year since I’ve been back that regulators (often lawyers such as yourselves) play an essential and much discussed role in shaping and strengthening the diverse and rapidly changing environment in which we work.

We have our own group of expert food and drug lawyers at the agency who have committed themselves to public service and to both defending the role and work of the FDA and recommending legal pathways that can improve the public health. And these days, they seem to be extra busy. But we also often rely on many of you—as a sounding board, a source of knowledge and understanding of current legal and regulatory issues including the impact of potential changes, as well as in promoting understanding and support for the fundamental structural basis for our work, which is essential not only for the public, but also for many of your clients.