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
Recent Orange and Purple Book legislation suggests a need to bridge drug and biologic patent regimes.
Authors: Authors: Walsh BS, Darrow JJ, Kesselheim AS.
Nat Biotechnol
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Premarket Development Times for Innovative Vaccines--To What Extent Are the Coronavirus Disease 2019 (COVID-19) Vaccines Outliers?
Authors: Authors: Beall RF, Kesselheim AS, Hollis A.
Clin Infect Dis
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Differences in Diabetic Prescription Drug Utilization and Costs Among Patients With Diabetes Enrolled in Colorado Marketplace and Medicaid Plans, 2014-2015.
Authors: Authors: Khorrami P, Sinha MS, Bhanja A, Allen HL, Kesselheim AS, Sommers BD.
JAMA Netw Open
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Patient and Caregiver Experiences With and Perceptions of Risk Evaluation and Mitigation Strategy Programs With Elements to Assure Safe Use.
Authors: Authors: Sarpatwari A, Brown BL, McGraw SA, Dejene SZ, Abdurrob A, Santiago Ortiz AJ, Kesselheim AS.
JAMA Netw Open
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Making the Case for Accelerated Withdrawal of Aducanumab.
Authors: Authors: Whitehouse P, Gandy S, Saini V, George DR, Larson EB, Alexander GC, Avorn J, Brownlee S, Camp C, Chertkow H, Fugh-Berman A, Howard R, Kesselheim A, Langa KM, Perry G, Richard E, Schneider L.
J Alzheimers Dis
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Associations Between Copays, Coverage Limits for Naloxone, and Prescribing in Medicaid.
Authors: Authors: Messinger JC, Kesselheim AS, Vine SM, Fischer MA, Barenie RE.
Subst Abuse
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High-Priced Sickle Cell Gene Therapies Threaten to Exacerbate US Health Disparities and Establish New Pricing Precedents for Molecular Medicine.
Authors: Authors: Tessema FA, Sarpatwari A, Rand LZ, Kesselheim AS.
J Law Med Ethics
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Reporting bias in clinical trials: Progress toward transparency and next steps.
Authors: Authors: Mitra-Majumdar M, Kesselheim AS.
PLoS Med
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Evidence at time of regulatory approval and cost of new antibiotics in 2016-19: cohort study of FDA approved drugs.
Authors: Authors: Mitra-Majumdar M, Powers JH, Brown BL, Kesselheim AS.
BMJ Med
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Payer-Specific Negotiated Prices for Prescription Drugs at Top-Performing US Hospitals.
Authors: Authors: Feldman WB, Rome BN, Brown BL, Kesselheim AS.
JAMA Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120