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
Frequency of Approval and Marketing of Biosimilars With a Skinny Label and Associated Medicare Savings.
Authors: Authors: Egilman AC, Van de Wiele VL, Rome BN, Darrow JJ, Tu SS, Kesselheim AS, Sarpatwari A.
JAMA Intern Med
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Trends in the Quality of Evidence Supporting FDA Drug Approvals: Results from a Literature Review.
Authors: Authors: Brown BL, Mitra-Majumdar M, Joyce K, Ross M, Pham C, Darrow JJ, Avorn J, Kesselheim AS.
J Health Polit Policy Law
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The Bayh-Dole Act at 40: Accomplishments, Challenges, and Possible Reforms.
Authors: Authors: Sarpatwari A, Kesselheim AS, Cook-Deegan R.
J Health Polit Policy Law
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Experts' Views on FDA Regulatory Standards for Drug and High-Risk Medical Devices: Implications for Patient Care.
Authors: Authors: Dhruva SS, Darrow JJ, Kesselheim AS, Redberg RF.
J Gen Intern Med
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Reforming the World Health Organization's Essential Medicines List: Essential but Unaffordable.
Authors: Authors: Hwang TJ, Kesselheim AS, Vokinger KN.
JAMA
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Medicaid Expenditures and Estimated Rebates on Line Extension Drugs, 2010-2018.
Authors: Authors: Hwang TJ, Feng J, Maini L, Kesselheim AS.
J Gen Intern Med
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Holding Pharmaceutical and Medical Device Executives Accountable as Responsible Corporate Officers.
Authors: Authors: Daval CJR, Avorn J, Kesselheim AS.
JAMA Intern Med
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Variations in Use of Diabetes Drugs With Cardiovascular Benefits Among Medicaid Patients.
Authors: Authors: Zhai MZ, Avorn J, Liu J, Kesselheim AS.
JAMA Netw Open
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Recent Trends in Prescription Drug Launch Prices-Reply.
Authors: Authors: Rome BN, Egilman AC, Kesselheim AS.
JAMA
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Fulfillment of Postmarket Commitments and Requirements for New Drugs Approved by the FDA, 2013-2016.
Authors: Authors: Brown BL, Mitra-Majumdar M, Darrow JJ, Moneer O, Pham C, Avorn J, Kesselheim AS.
JAMA Intern Med
View full abstract on Pubmed

Address: 
Brigham and Women's Hospital
Boston, MA 02120