Remarks by the Acting Commissioner of Food and Drugs

Norman Sharpless, MD

Food and Drug Law Institute Annual Conference
May 2, 2019
Washington, DC

Thank you Jennifer [Bragg] for that introduction. And thank you also Amy [Comstock Rick] for all the work you do running this organization. I’m delighted to be with all of you today.

FDLI is an important organization that has long served as a key partner and advocate for FDA’s work.

I use the word “advocate” here not because I’m standing in a room with so many lawyers, or because you always agree with everything we do at FDA. (In fact, I doubt very much whether we could ever get a group of lawyers to agree on everything on just about any topic . . . .)

No, I use the word advocate to describe your relationship with FDA and because of your keen understanding of the FDA’s mission.

Your expertise and engagement on the broad range of issues we address reinforces and strengthens our efforts to use science in the development of law and policies that make a meaningful difference to the health and safety of the American public.

I will confess to a small amount of trepidation—as a doctor and cancer researcher—about talking to a group of so many lawyers. I speak doctor; I don’t really speak lawyer. Despite differences in language, however, I think the medical and legal professions share many important qualities. The relationship of a doctor and patient is like that of a lawyer and client. In both cases, the relationship is one of service.

At the FDA, that patient or client, if you will, is the public health of Americans.

Perhaps I won’t be able to fully bridge the doctor-lawyer divide for this audience, but in that case I also came prepared. Later today, after lunch, you’ll be hearing from FDA’s top lawyer, Stacy Amin, and I’m sure she’ll be able to advance some of the same points I’m making in appropriate legalese—with requisite ipso factos and nolo contenderes as needed.