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
The New Centers for Medicare and Medicaid Services Patient-Reported Outcome-Based Performance Measure: What It Means and How Can I Align.
Journal Article The Journal of the American Academy of Orthopaedic Surgeons · May 2025 The recognition of the benefits of the measurement and utilization of patient-reported outcome measures (PROMs) in clinical care continues to increase. Furthermore, the Centers for Medicare and Medicaid Services recently mandated a patient-reported outcome ... Full text CiteWhy a Planned Reorganization of the FDA Creates Major Challenges.
Journal Article JAMA health forum · May 2025 Full text CiteA Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators.
Journal Article Pharmacoepidemiology and drug safety · March 2025 BackgroundInternational harmonization of real-world data and evidence (RWD/E) standards is a goal among real-world data/real-world evidence (RWD/E) policy stakeholders. The Duke-Robert J. Margolis Institute for Health Policy developed an online 'I ... 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 - 2028CF 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 - 2028Accelerating Value-Based Care Impact at the State and National Level
ResearchDirector · Awarded by Gary and Mary West Health Institute · 2023 - 2027View All Grants