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
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.
Authors: Authors: Kesselheim AS, Darrow JJ.
Clin Pharmacol Ther
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Medical device postapproval safety monitoring: where does the United States stand?
Authors: Authors: Rajan PV, Kramer DB, Kesselheim AS.
Circ Cardiovasc Qual Outcomes
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A New Wave of Vaccines for Non-Communicable Diseases: What Are the Regulatory Challenges?
Authors: Authors: Darrow JJ, Kesselheim AS.
Food Drug Law J
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Hatch-Waxman Turns 30: Do We Need a Re-Designed Approach for the Modern Era?
Authors: Authors: Kesselheim AS, Darrow JJ.
Yale J Health Policy Law Ethics
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Burden of changes in generic pill appearance.
Authors: Authors: Kesselheim AS, Choudhry NK, Avorn J.
Ann Intern Med
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Innovative research methods for studying treatments for rare diseases: methodological review.
Authors: Authors: Gagne JJ, Thompson L, O'Keefe K, Kesselheim AS.
BMJ
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High-cost generic drugs--implications for patients and policymakers.
Authors: Authors: Alpern JD, Stauffer WM, Kesselheim AS.
N Engl J Med
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Chemotherapy parity laws: a remedy for high drug costs?
Authors: Authors: Wang B, Joffe S, Kesselheim AS.
JAMA Intern Med
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Ensuring patient privacy in data sharing for postapproval research.
Authors: Authors: Sarpatwari A, Kesselheim AS, Malin BA, Gagne JJ, Schneeweiss S.
N Engl J Med
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Health policy basics: the Physician Payment Sunshine Act and the Open Payments program.
Authors: Authors: Kirschner NM, Sulmasy LS, Kesselheim AS.
Ann Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120