23rd Commissioner of the FDA / Partner at New Enterprise Associates and Senior Fellow at American Enterprise Institute
Scott Gottlieb, MD, is a senior fellow at the American Enterprise Institute (AEI). He returned to AEI in 2019 after serving as the 23rd commissioner of the Food and Drug Administration (FDA). At AEI, he continues his work on improving public health through entrepreneurship and medical innovation and on expanding regulatory approaches to maintain patient and physician autonomy. Dr. Gottlieb is also a special partner with the venture capital firm New Enterprise Associates and serves on the boards of Pfizer, Illumina, Aetion, and Tempus.
At the FDA, Dr. Gottlieb focused on a wide variety of issues, including drug pricing, medical product innovation, food safety, vaccination, and tobacco and vaping. He advanced new policies to address opioid addiction, working to rationalize prescribing as a way to reduce the rate of new addiction. He helped make the regulatory process for the development and review of novel drug and medical devices more efficient, including the approval of the first gene-therapy-based cancer treatment. He also presided over a record number of novel drug and medical device approvals in 2017 — and then broke that record in 2018.
Dr. Gottlieb helped promote competition through the approval of a record number of generic drugs, including the creation of new pathways for developing generic copies of complex drugs. He also helped advance the FDA’s Oncology Center for Excellence, which fosters a collaborative scientific environment to improve the development and regulation of oncology products. In addition, he helped implement the 21st Century Cures Act to accelerate medical product development.
Dr. Gottlieb previously served in other capacities at the FDA, including as deputy commissioner for medical and scientific affairs, senior adviser for medical technology, and director of medical policy development. Earlier, he served as senior policy adviser to the administrator at the Centers for Medicare & Medicaid Services. Until he joined the FDA as commissioner, he was also a clinical assistant professor at New York University School of Medicine. Earlier, he was a practicing physician and hospitalist concurrently with his AEI work.
In addition to his frequent testimonies before Congress, Dr. Gottlieb is often published and interviewed by the media. A contributor to CNBC, his interviews range from Face The Nation, CBS News to Fox News, and his commentary and articles have appeared in Health Affairs, The Wall Street Journal, The Washington Post, and The New York Times, among other outlets.
Dr. Gottlieb has a medical degree from Mount Sinai School of Medicine and did his residency in internal medicine at the Mount Sinai Medical Center. He has a BA in economics from Wesleyan University.