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
Underrepresentation of older adults in cancer trials.
Authors: Authors: Luo J, Kesselheim AS.
JAMA
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Strategies for postmarketing surveillance of drugs for rare diseases.
Authors: Authors: Kesselheim AS, Gagne JJ.
Clin Pharmacol Ther
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Assessing the chiral switch: approval and use of single-enantiomer drugs, 2001 to 2011.
Authors: Authors: Gellad WF, Choi P, Mizah M, Good CB, Kesselheim AS.
Am J Manag Care
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The evolving role of biomarker patents in personalized medicine.
Authors: Authors: Kesselheim AS, Shiu N.
Clin Pharmacol Ther
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Quantifying The Food And Drug Administration's rulemaking delays highlights the need for transparency.
Authors: Authors: Hwang TJ, Avorn J, Carpenter D, Kesselheim AS.
Health Aff (Millwood)
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FDA approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012.
Authors: Authors: Rome BN, Kramer DB, Kesselheim AS.
JAMA
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Assessment of US pathway for approving medical devices for rare conditions.
Authors: Authors: Hwang TJ, Carpenter D, Kesselheim AS.
BMJ
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Evidence, errors, and ethics.
Authors: Authors: Miller FG, Joffe S, Kesselheim AS.
Perspect Biol Med
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Approval of high-risk medical devices in the US: implications for clinical cardiology.
Authors: Authors: Rome BN, Kramer DB, Kesselheim AS.
Curr Cardiol Rep
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Medical innovation then and now: perspectives of innovators responsible for transformative drugs.
Authors: Authors: Xu S, Kesselheim AS.
J Law Med Ethics
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Address: 
Brigham and Women's Hospital
Boston, MA 02120