FDA Voice: Dr. Spielberg, thank you for agreeing to let us interview you for FDA Voice. Can you tell us about your position at FDA and what that entails?
Dr. Spielberg: I am the Deputy Commissioner for Medical Products and Tobacco. In creating this new position, Commissioner Hamburg envisioned that it would “provide high-level coordination and leadership across the Centers for drug, biologics, medical devices, and tobacco products, and support, coordinate and advocate for the work and needs of the Centers.” In my short time at FDA, I have been working with the Center Directors and their staff to understand shared challenges and opportunities to advance regulatory science and practice across all “human products”. Together, we have begun to define areas of mutual interest and synergy where we can work together and with external partners in the public and private sectors to bring the best of science to bear on our public health responsibilities, to advance managerial and operations support to optimize our core tasks, and to assure in everything we do that FDA is at the cutting edge of promoting and protecting the public health.
Dr. Spielberg: Throughout my career, I have been involved with FDA. In fact, my MD-PhD training at the University of Chicago, particularly in the Department of Pharmacology, was in the context of former UC faculty (Drs. E.M.K. Geiling and Francis Kelsey) who were intimately involved with creation of FDA by their work on elixir of sulfanilamide (Federal Food, Drug, and Cosmetic Act of 1938) and thalidomide (Drug Amendments of 1962). So, in retrospect, I suppose I “grew up” with knowledge and appreciation of FDA. Over the years, I have served as a member of the Pediatric Subcommittee, the Science Board, rapporteur for ICH E-11, and helped get BPCA and PREA through Congress. At this stage of my career, it is a true honor for me to be able to serve the Agency at a critical time in biomedical science and therapeutics.
FDA Voice: What did you do before joining FDA?
Dr. Spielberg: I have had a 35 year career as a pediatrician and clinical pharmacologist, including in academic settings in the US and Canada, as well as in the pharmaceutical industry. My research career has focused on human pharmacogenetics and pharmacogenomics, mechanisms of adverse drug reactions, and pediatric/development pharmacology and pediatric clinical trials. In the years prior to coming to FDA, I was Dean of Dartmouth Medical School, and subsequently headed a new personalized medicine program at Children’s Mercy Hospital in Kansas City, MO, as well as working with the Institute for Pediatric Innovation, a non-profit organization focused on advancing therapeutics for children.
FDA Voice: What is the favorite part of your job here at FDA?
Dr. Spielberg: This is a remarkable time to be at FDA. Biomedical science is advancing at an incredible rate. We are now beginning to see the impact of genomic and other science in defining the causes of disease, and in the discovery and development of new therapies. Medicine now is at a place that I could barely have imagined when I began my career, but we have the age old challenges of how to skillfully and wisely use the knowledge we have at any time to advance the health of individual patients and of all patients we serve. At such a time, what could be more challenging and satisfying than being here at FDA and having the opportunity to advance the promotion and protection of the public health.
FDA Voice: If you could tell the American public one thing that you think they don’t know about what your office does to directly benefit them, what would it be?
Dr. Spielberg: Every day, I am impressed by the outstanding, dedicated, hard working people here at FDA. Their focus on our public health mission is remarkable, and it is an honor to work with them.
FDA Voice: Dr. Spielberg, thank you so much for your time!
Stephen Spielberg, MD, PhD, is Deputy Commissioner for Medical Products and Tobacco