Randall Lutter, Ph.D., is a senior fellow at the Manhattan Institute, where his research focuses on pharmaceutical markets and policy, medical innovation, and regulation. As senior science and regulatory advisor in the Office of the Commissioner at the U.S. Food and Drug Administration (FDA) from 2017 to 2020, Dr. Lutter led projects involving competition in pharmaceutical markets and drug pricing, the regulation of tobacco products, and surveillance of medical product supply chains disrupted by Covid-19. His work draws from more than 25 years of senior experience in the analysis and management of federal programs to protect health, safety, and the environment.

Dr. Lutter previously served at FDA from 2003 to 2009, first as chief economist and later as deputy commissioner for policy, playing a leadership role in the development of new policies for genetically engineered animals, animal clones, prevention of mad cow disease, and updating user fee programs for drugs and medical devices and managing advisory committees. He also served on the faculty at the Frank Batten School of Leadership and Public Policy at the University of Virginia and worked as senior economist at the federal Office of Management and Budget and the President’s Council of Economic Advisers. He has been a visiting fellow at Resources for the Future, resident scholar at the American Enterprise Institute, fellow at the AEI-Brookings Joint Center for Regulatory Studies, and a faculty member at the State University of New York at Buffalo.

Dr. Lutter holds a Bachelor of Arts in economics from the University of California-Berkeley as well as a Ph.D. in economics from Cornell University. He has authored or co-authored more than 60 technical and policy papers that have appeared in journals like the American Economic Review, the Journal of Political Economy, and Science, and his popular writing is in Politico and Regulation.