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
Variations in pill appearance of antiepileptic drugs and the risk of nonadherence.
Authors: Authors: Kesselheim AS, Misono AS, Shrank WH, Greene JA, Doherty M, Avorn J, Choudhry NK.
JAMA Intern Med
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FDA regulation of off-label drug promotion under attack.
Authors: Authors: Kesselheim AS, Mello MM, Avorn J.
JAMA
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The ethics of intellectual property rights in an era of globalization.
Authors: Authors: Shah AK, Warsh J, Kesselheim AS.
J Law Med Ethics
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Rising health care costs and life-cycle management in the pharmaceutical market.
Authors: Authors: Kesselheim AS.
PLoS Med
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Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009.
Authors: Authors: Outterson K, Powers JH, Seoane-Vazquez E, Rodriguez-Monguio R, Kesselheim AS.
J Law Med Ethics
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Postmarket surveillance of medical devices: a comparison of strategies in the US, EU, Japan, and China.
Authors: Authors: Kramer DB, Tan YT, Sato C, Kesselheim AS.
PLoS Med
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Drug labels: a flawed source of data for studying orphan drug approvals.
Authors: Authors: Kesselheim AS, Avorn J.
Clin Pharmacol Ther
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Risk, responsibility, and generic drugs.
Authors: Authors: Kesselheim AS, Avorn J, Greene JA.
N Engl J Med
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Origins of medical innovation: the case of coronary artery stents.
Authors: Authors: Xu S, Avorn J, Kesselheim AS.
Circ Cardiovasc Qual Outcomes
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User fees and beyond--the FDA Safety and Innovation Act of 2012.
Authors: Authors: Kramer DB, Kesselheim AS.
N Engl J Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120