Aaron S. Kesselheim, MD, JD, MPH

Aaron S. Kesselheim, MD, JD, MPH

Professor of Medicine, Harvard Medical School

Director, PORTAL

Aaron Kesselheim is Professor of Medicine at Harvard Medical School and Director of PORTAL. He founded PORTAL as an interdisciplinary research center focusing on the intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. He is also a primary care physician at the Phyllis Jen Center for Primary Care at Brigham and Women’s Hospital.

Dr. Kesselheim is the author of over 700 publications in the peer-reviewed medical and health policy literature and was recognized as one of the top three most-cited health law scholars in the US from 2013–2020. He has testified before Congress on pharmaceutical policy, medical device regulation, generic drugs, modernizing clinical trials, and other topics. He is editor-in-chief of the Journal of Law, Medicine, and Ethics, and in 2020 he was elected to the National Academy of Medicine.

Dr. Kesselheim is a core faculty member at the HMS Center for Bioethics, where he co-teaches a course on health policy, law, and bioethics and organizes a monthly policy and ethics seminar series. He also serves as a Visiting Professor of Law at Yale Law School, where he teaches a yearly course on Food and Drug Administration Law and Policy. With PORTAL colleagues, he developed the HarvardX massive open online course Prescription Drug Regulation, Cost, and Access: Current Controversies in Context, which has reached over 100,000 participants worldwide.

Dr. Kesselheim received his MD and JD from the University of Pennsylvania and his MPH from the Harvard School of Public Health. He completed his residency in internal medicine at Brigham and Women’s Hospital and a fellowship in general internal medicine at Harvard Medical School.

Featured Work

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Pharmaceutical Policy in the United States in 2019: An Overview of the Landscape and Avenues for Improvement

Kesselheim AS, Sinha MS, Avorn J, Sarpatwari A - Stanford Law & Policy Review

  • Innovation Incentives and Competition
  • Price, Value, and Access
  • Regulation and Clinical Evidence
This comprehensive review examines the US pharmaceutical policy landscape across multiple domains—including innovation, drug pricing, generic and biosimilar competition, and regulatory oversight—noting that while the US spends approximately $450 billion annually on prescription drugs and benefits from a vibrant generic marketplace, high brand-name drug prices threaten access to both new transformative therapies and decades-old essential products like insulin and antibiotics. The authors identify avenues for improvement through reforms to the FDA’s regulatory framework, strategies to curb brand-name manufacturers’ tactics for delaying generic competition, and measures to address rising prices for both new and existing drugs.
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The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform

Kesselheim AS, Avorn J, Sarpatwari A - JAMA

  • Innovation Incentives and Competition
  • Price, Value, and Access
  • Regulation and Clinical Evidence
US per capita prescription drug spending ($858 in 2013) far exceeds that of other industrialized nations (average $400), driven primarily by brand-name drug prices set based on what the market will bear rather than research and development costs, with government-granted monopoly rights and constrained payer negotiating power as the key enabling factors. The authors recommend short-term strategies including stricter exclusivity requirements, ensuring timely generic availability, expanding governmental price negotiation, generating comparative cost-effectiveness evidence, and better educating stakeholders to address rising drug costs.
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Determinants of Market Exclusivity for Prescription Drugs in the United States

Kesselheim AS, Sinha MS, Avorn J - JAMA Internal Medicine

  • Innovation Incentives and Competition
Brand-name prescription drugs in the US receive approximately 12 to 16 years of market exclusivity through a combination of patent protection (up to 20 years with extensions) and FDA-granted regulatory exclusivities (6-7 years for small-molecule drugs, 12 years for biologics), which enables manufacturers to maintain high prices by blocking generic competition. Policy reforms should aim to balance the need for fair industry returns on investment with timely access to lower-cost generic alternatives to improve drug affordability and address public health needs.
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