Scott Gottlieb

Resident Fellow on Health Policy Studies, The American Enterprise Institute
Scott Gottlieb

Scott Gottlieb

Resident Fellow on Health Policy Studies, The American Enterprise Institute

Biography

Scott Gottlieb, MD, served as the 23rd Commissioner of the US Food and Drug Administration (FDA). His work focuses on advancing public health through developing and implementing innovative approaches to improving medical outcomes, reshaping health care delivery, and expanding consumer choice and safety. Dr. Gottlieb is an aggressive advocate for advancing the health of patients, promoting health care access, and driving innovation. The FDA’s historic and prolific advances in new policy distinguished his tenure as the agency’s Commissioner, as did a record-setting number of approvals of novel drugs, medical devices, and generic medicines.

Under Dr. Gottlieb’s leadership, the FDA advanced new frameworks for the modern, safe, and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs, and digital health devices. The agency implemented new reforms to standardize drug reviews and make historic improvements of post-market data collection and the use of real-world evidence (RWE). The FDA also promoted policies to reduce death and disease from tobacco, improve food innovation and safety, and aggressively confront addiction crises.

Previously, Dr. Gottlieb served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and, before that, as a senior advisor to the Administrator of the Centers for Medicare and Medicaid Services (CMS), where he helped advance policies to improve health care quality and promote the effective use of new medical technologies. A health care futurist, he has worked as a venture capitalist and as a founder and board member of companies that have developed new medicines and have advanced the delivery of health care.

Dr. Gottlieb is widely published in leading medical journals and in periodicals such as The Wall Street Journal, The New York Times, and The Washington Post. He has held editorial positions at The British Medical Journal and The Journal of the American Medical Association (JAMA), and appears regularly as a guest commentator on CNBC and Fox News. He was a practicing hospitalist and a clinical assistant professor at the New York University School of Medicine. Dr. Gottlieb is presently a resident fellow at the American Enterprise Institute in Washington, DC.

Session by Scott Gottlieb