Scott Gottlieb (born June 11, 1972) is an American physician and investor who served as the 23rd commissioner of the Food and Drug Administration (FDA) from May 2017 until April 2019. He is presently a senior fellow at the conservative think tank the American Enterprise Institute (AEI), a partner at the venture capital firm New Enterprise Associates (NEA), a member of the board of directors of drug maker Pfizer, Inc, a member of the board of directors of Illumina, Inc., a contributor to the cable financial news network CNBC, and a frequent guest on the CBS News program Face the Nation. An elected member of the National Academy of Medicine, Gottlieb is the author of The New York Times best selling book Uncontrolled Spread on the COVID-19 pandemic and the national security vulnerabilities that it revealed.
Before becoming FDA Commissioner, he was a Clinical Assistant Professor at New York University Grossman School of Medicine, the FDA's Deputy Commissioner for Medical and Scientific Affairs, a venture partner with NEA, a member of the policy board of the Leukemia & Lymphoma Society, a senior official at the Centers for Medicare & Medicaid Services, and a member of the Federal Health Information Technology Policy Committee, which advises the United States Department of Health and Human Services on healthcare information technology. He was previously a resident fellow at AEI from 2007 to 2017, prior to joining the FDA as Commissioner in May 2017.
Early life and education
Gottlieb grew up in East Brunswick, New Jersey, the son of Stanley, who was a psychiatrist, and Marsha Gottlieb. He received his bachelor's degree in economics from Wesleyan University. After completing his undergraduate education, he worked as a healthcare analyst at the investment bank Alex. Brown & Sons in Baltimore. Gottlieb attended medical school at Icahn School of Medicine at Mount Sinai and completed his residency in internal medicine at the Mount Sinai Hospital. He is Jewish.
Career
FDA and CMS (2003–2007) Gottlieb worked for the U.S. Food and Drug Administration (FDA) from 2002 to 2003 and 2005 to 2007. He first served as a senior advisor to the FDA Commissioner and then as the FDA's Director of Medical Policy Development from 2002 to 2003. He helped initiate the FDA's generic drug user fee program and the Physician Labeling Rule. He worked on development of the FDA's policies related to the tentative approval of fixed-dose combination drugs for the treatment of HIV/AIDS under the PEPFAR program. He left the FDA in the spring of 2003 to become a senior advisor to the Administrator of the Centers for Medicare & Medicaid Services (CMS), where he worked on implementation of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), with its new Part D drug benefit, and helped advance the agency's coverage policies related to new medical technology.
He returned to the FDA from 2005 to 2007 as the agency's Deputy Commissioner for Medical and Scientific Affairs, where he was appointed to the Senior Executive Service and granted a top secret security clearance. He was a member of the Biodefense Interagency Working Group to help draft a strategic plan for U.S. biodefense countermeasures. He also worked on advancing a framework for the creation of a generic drug user fee program, final implementation of the physician labelling and pregnancy labelling rules, and pandemic preparedness. In that latter role, Gottlieb recused himself from key parts of the planning effort on a bird flu vaccine in 2005, because he had done consulting work for companies whose products might be used.
Private sector (2007–2017) Gottlieb practiced internal medicine as an attending physician at New York University's Tisch Hospital in New York City.
In 2007, Gottlieb became a venture partner at New Enterprise Associates (NEA), the world's largest venture capital firm by assets under management. Gottlieb served as an active investing partner in the firm's healthcare division. He served on the boards of directors of several NEA portfolio companies, including Bravo Health (a Medicare Advantage health plan) and American Pathology Partners (a specialized anatomical pathology service provider). Gottlieb remained at NEA from 2007 until his appointment to be FDA Commissioner in May 2017.