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
The Trans-Pacific Partnership Agreement and Implications for Access to Essential Medicines.
Authors: Authors: Luo J, Kesselheim AS.
JAMA
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Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness.
Authors: Authors: Kesselheim AS, Gagne JJ.
Drug Saf
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Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014.
Authors: Authors: Luo J, Avorn J, Kesselheim AS.
JAMA Intern Med
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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.
Authors: Authors: Kesselheim AS, Wang B, Franklin JM, Darrow JJ.
BMJ
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Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review.
Authors: Authors: Wang B, Kesselheim AS.
BMJ
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FDA Policy and Cardiovascular Medicine.
Authors: Authors: Ross JS, Kesselheim AS.
Circulation
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Forbidden and Permitted Statements about Medications--Loosening the Rules.
Authors: Authors: Avorn J, Sarpatwari A, Kesselheim AS.
N Engl J Med
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Erratum to: Methodological Approaches to Evaluate the Impact of FDA Drug Safety Communications.
Authors: Authors: Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J.
Drug Saf
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Propofol as a transformative drug in anesthesia: insights from key early investigators.
Authors: Authors: Bateman BT, Kesselheim AS.
Drug Discov Today
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The Safety of Prescription Drugs.
Authors: Authors: Sharfstein JM, Kesselheim AS.
JAMA
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Address: 
Brigham and Women's Hospital
Boston, MA 02120