Aaron Seth Kesselheim

Aaron Seth Kesselheim, MD, JD, MPH

Professor of Medicine
Member, HMS Center for Bioethics

Aaron S. Kesselheim, MD, JD, MPH, is a Professor of Medicine at Harvard Medical School and a faculty member in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. Within the Division, Aaron created and leads the Program On Regulation, Therapeutics, And Law (PORTAL, www.PORTALresearch.org), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. PORTAL is now among the largest, independent academic centers focusing on these issues in the country (Twitter: @PORTAL_research, @akesselheim). Dr. Kesselheim received his medical and legal training at the University of Pennsylvania and his M.P.H. at the Harvard School of Public Health. Author of over 450 publications in the peer-reviewed medical and health policy literatures, Aaron has testified before Congress on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, is a member of the FDA Peripheral and Central Nervous System Advisory Committee, and served on a National Academies of Science, Engineering and Medicine consensus committees on addressing the opioid epidemic and bioidentical hormone replacement. At the HMS Center for Bioethics, he co-teaches a course on health policy, law, and bioethics and organizes the monthly policy and ethics consortium.

Publications View
Patient Assistance Programs and the Anti-Kickback Statute: Charting a Pathway Forward.
Authors: Authors: Sinha MS, Kesselheim AS, Robertson CT.
JAMA
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Aducanumab and Accelerated Approval: Where Do We Go From Here?
Authors: Authors: Kesselheim AS.
Clin Pharmacol Ther
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Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration.
Authors: Authors: Feldman D, Avorn J, Kesselheim AS.
JAMA Netw Open
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QALYs In Health Resource Usage Decisions: The Authors Reply.
Authors: Authors: Rand LZ, Kesselheim AS.
Health Aff (Millwood)
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New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
Authors: Authors: Moneer O, Brown BL, Avorn J, Darrow JJ, Mitra-Majumdar M, Joyce KW, Ross M, Pham C, Kesselheim AS.
Drug Saf
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Biosimilar competition: Early learning.
Authors: Authors: Frank RG, Shahzad M, Kesselheim AS, Feldman W.
Health Econ
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A New Way to Contain Unaffordable Medication Costs - Exercising the Government's Existing Rights.
Authors: Authors: Engelberg AB, Avorn J, Kesselheim AS.
N Engl J Med
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Switching to Over-the-Counter Availability of Rescue Inhalers for Asthma.
Authors: Authors: Feldman WB, Avorn J, Kesselheim AS.
JAMA
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US Taxpayers Heavily Funded the Discovery of COVID-19 Vaccines.
Authors: Authors: Lalani HS, Avorn J, Kesselheim AS.
Clin Pharmacol Ther
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Medicaid Spending on Drugs Marketed Without US Food and Drug Administration Approval in 2020.
Authors: Authors: Gunter SJ, Kesselheim AS, Rome BN.
JAMA Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120