Scott Gottlieb is an American physician and public health official known for his work on health policy and medical regulation. He served as commissioner of the U.S. Food and Drug Administration from 2017 to 2019, a period in which the agency focused on issues such as opioid harms, tobacco and vaping regulation, and drug competition. For a physician biography and professional background, see the profile at physician profile.

Early career and medical practice

Gottlieb trained in medicine and practiced as an internist, including clinical work at Tisch Hospital. He has held academic appointments such as a clinical assistant professorship at New York University School of Medicine and has been involved in health policy research and commentary. Before his FDA appointment he combined clinical work with policy roles and public commentary, contributing to debates on drug pricing, regulatory reform, and clinical safety.

Service at the Food and Drug Administration

As FDA commissioner from 2017 to 2019, Gottlieb led the agency through a mix of regulatory reviews and policy initiatives. The FDA under his leadership emphasized speeding access to generics and biosimilars, addressing opioid misuse and overdose prevention, tightening controls around flavored electronic nicotine delivery systems, and modernizing the agency’s approach to medical devices and digital health.

Major focus areas

  • Opioid policy: efforts to reduce addiction risks and improve pain-management practices.
  • Tobacco and vaping: moves toward restricting youth-oriented products and flavors.
  • Drug competition: promoting faster approvals for generic medicines to lower costs.
  • Regulatory modernization: adapting oversight to new technologies in diagnostics and devices.

During and after his tenure, his positions and prior industry ties drew public scrutiny and discussion about the balance between regulatory experience and private-sector relationships. Details of his FDA leadership and initiatives are discussed in profiles of his commissioner role at FDA commissioner profile and at the agency itself, Food and Drug Administration.

After leaving the agency, Gottlieb continued to participate in public discourse on health policy as a resident fellow at the American Enterprise Institute (AEI), through writing, media appearances, and advisory roles. He remains a prominent voice on public health preparedness, regulatory policy, and how medical innovation can be balanced with patient safety.