Dr. Robert M. Califf serves as the Commissioner of Food and Drugs at the U.S. Food and Drug Administration, having been sworn in for his second term on February 17, 2022. Previously, he held the same position from February 2016 to January 2017, following his service as FDA's Deputy Commissioner for Medical Products and Tobacco from February 2015. Before returning to the FDA, Dr. Califf served as head of medical strategy and Senior Advisor at Alphabet Inc., where he contributed to strategy and policy for Verily Life Sciences and Google Health. His extensive academic background includes serving as professor of medicine and vice chancellor for clinical and translational research at Duke University, where he also founded and directed the Duke Clinical Research Institute. A graduate of Duke University School of Medicine, he completed his internal medicine residency at the University of California, San Francisco and cardiology fellowship at Duke.
Dr. Califf is nationally and internationally recognized as an expert in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research methodology. He has led numerous landmark clinical trials that have shaped evidence-based medical practice and established new standards for therapeutic interventions. With more than 1,300 peer-reviewed publications, he ranks among the most frequently cited authors in biomedical science, reflecting the significant impact of his scholarly contributions. His expertise in translational research has been instrumental in bridging the gap between scientific discovery and clinical application, ensuring that advances in medical science translate effectively into patient care. Dr. Califf's methodological innovations in clinical trial design and health outcomes assessment have become foundational elements in modern evidence-based medicine.
As a Member of the National Academy of Medicine since 2016, Dr. Califf has significantly influenced healthcare policy and medical research standards through his service on numerous Institute of Medicine committees. He currently oversees the full breadth of the FDA's portfolio, including human and veterinary drugs, vaccines, medical devices, food safety, and tobacco regulation, ensuring these products meet rigorous standards for safety and efficacy. Dr. Califf has served on advisory committees for multiple National Institutes of Health, contributing his expertise to advance biomedical research across diverse therapeutic areas. His leadership style emphasizes strengthening programs and policies that enable the FDA to fulfill its mission of protecting and promoting public health through science-based regulation. Dr. Califf continues to champion initiatives that harness technological innovation while maintaining the highest standards of scientific integrity in regulatory decision-making.