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
Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study.
Authors: Authors: Gyawali B, Rome BN, Kesselheim AS.
BMJ
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Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe.
Authors: Authors: Vokinger KN, Hwang TJ, Daniore P, Lee CC, Tibau A, Grischott T, Rosemann TJ, Kesselheim AS.
JAMA Oncol
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Controversy Over Using Quality-Adjusted Life-Years In Cost-Effectiveness Analyses: A Systematic Literature Review.
Authors: Authors: Rand LZ, Kesselheim AS.
Health Aff (Millwood)
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How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?
Authors: Authors: Brown BL, Kesselheim AS.
AMA J Ethics
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The timing of 30-month stay expirations and generic entry: A cohort study of first generics, 2013-2020.
Authors: Authors: Kannappan S, Darrow JJ, Kesselheim AS, Beall RF.
Clin Transl Sci
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Revisiting FDA Approval of Aducanumab.
Authors: Authors: Alexander GC, Knopman DS, Emerson SS, Ovbiagele B, Kryscio RJ, Perlmutter JS, Kesselheim AS.
N Engl J Med
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FDA Regulation and Approval of Medical Devices: 1976-2020.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
JAMA
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Barriers To US Biosimilar Market Growth: Lessons From Biosimilar Patent Litigation.
Authors: Authors: Van de Wiele VL, Kesselheim AS, Sarpatwari A.
Health Aff (Millwood)
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Market Exclusivity and Changes in Competition and Prices Associated With the US Food and Drug Administration Unapproved Drug Initiative.
Authors: Authors: Gunter SJ, Kesselheim AS, Rome BN.
JAMA Intern Med
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Frequency of First Generic Drug Approvals With "Skinny Labels" in the United States.
Authors: Authors: Walsh BS, Sarpatwari A, Rome BN, Kesselheim AS.
JAMA Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120