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
A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs.
Authors: Authors: Sarpatwari A, Mitra-Majumdar M, Bykov K, Avorn J, Woloshin S, Toyserkani GA, LaCivita C, Manzo C, Zhou EH, Pinnow E, Dal Pan GJ, Gagne JJ, Huybrechts KF, Feldman WB, Chin K, Kesselheim AS.
Drug Saf
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FDA approval standards for anticancer agents - lessons from two recent approvals in breast cancer.
Authors: Authors: Gyawali B, Kesselheim AS.
Nat Rev Clin Oncol
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Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling.
Authors: Authors: Gyawali B, Darrow JJ, Kesselheim AS.
JAMA Intern Med
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Association of California's Prescription Drug Coupon Ban With Generic Drug Use.
Authors: Authors: Rome BN, Gagne JJ, Kesselheim AS.
JAMA
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Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases.
Authors: Authors: Liu S, Mello MM, Kesselheim AS.
J Health Polit Policy Law
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Factors Associated With Generic Drug Uptake in the United States, 2012 to 2017.
Authors: Authors: Rome BN, Lee CC, Gagne JJ, Kesselheim AS.
Value Health
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The Wrong Cure: Financial Incentives for Unimpressive New Antibiotics.
Authors: Authors: Sinha MS, Powers JH, Kesselheim AS.
J Infect Dis
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Evaluation of Aducanumab for Alzheimer Disease: Scientific Evidence and Regulatory Review Involving Efficacy, Safety, and Futility.
Authors: Authors: Alexander GC, Emerson S, Kesselheim AS.
JAMA
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Frequency Of Generic Drug Price Spikes And Impact On Medicaid Spending.
Authors: Authors: Patel AN, Kesselheim AS, Rome BN.
Health Aff (Millwood)
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Diabetes Drugs: List Price Increases Were Not Always Reflected In Net Price; Impact Of Brand Competition Unclear.
Authors: Authors: Sarpatwari A, Tessema FA, Zakarian M, Najafzadeh MN, Kesselheim AS.
Health Aff (Millwood)
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Address: 
Brigham and Women's Hospital
Boston, MA 02120