Overview
Mark McClellan, MD, PhD, is a physician-economist who focuses on quality and value in health care, including payment and coverage reform, real-world evidence, more effective policies to support drug and device innovation, and initiatives to increase the impact of health care, public health, and social service programs on population health. His work on responding to the COVID-19 public health emergency spanned virus containment and testing strategies, reforming health care toward more resilient models of delivering care, and accelerating the development of therapeutics and vaccines, including a COVID-19 response roadmap. He is former commissioner of the U.S. Food and Drug Administration, and former administrator of the Centers for Medicare & Medicaid Services, where he developed and implemented major reforms in health policy. He has also served as a member of the President’s Council of Economic Advisors and as a Deputy Assistant Secretary for Economic Policy at the Department of the Treasury. He was previously Associate Professor of Economics with tenure at Stanford University. Dr. McClellan is an independent board member on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ; chairs the National Academy of Medicine’s Leadership Consortium for a Value and Science-Driven Health System; co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network; and serves as an advisor for Blackstone Life Sciences, Arsenal Capital Partners, and MITRE.
Current Appointments & Affiliations
In the News
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Recent Publications
A Threat to Evidence-Based Vaccine Policy and Public Health Security at the FDA.
Journal Article N Engl J Med · January 1, 2026 Full text Link to item CitePartnerships to advance patient safety and address preventable harm: case studies from international health care leaders
Journal Article Health Affairs Scholar · January 1, 2026 There have been notable improvements in patient safety in recent years; however, significant challenges remain in reducing the incidence of preventable patient harm. Supporting patient safety efforts is increasingly important given increasing complexity of ... Full text CiteModernizing Risk Adjustment for Value-Based Care Without Clinician Burnout.
Journal Article JAMA health forum · October 2025 Full text CiteRecent Grants
Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed
ResearchAdvisor · Awarded by Food and Drug Administration · 2024 - 2029CF Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)
ResearchAdvisor · Awarded by Food and Drug Administration · 2018 - 2028Addressing Health-Related Social Needs in Clinical Practice
ResearchAdvisor · Awarded by Duke Endowment · 2025 - 2028View All Grants