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
Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19.
Authors: Authors: Naci H, Kesselheim AS, Røttingen JA, Salanti G, Vandvik PO, Cipriani A.
BMJ
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Accounting for US public funding in drug development: how can we better balance access, affordability, and innovation?
Authors: Authors: Sarpatwari A, Avorn J, Kesselheim AS.
BMJ
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Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.
Authors: Authors: Hwang TJ, Ross JS, Vokinger KN, Kesselheim AS.
BMJ
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Regulatory Decision-making on COVID-19 Vaccines During a Public Health Emergency.
Authors: Authors: Avorn J, Kesselheim A.
JAMA
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Clinical Development Times for Biosimilars in the United States.
Authors: Authors: Lee CC, Kesselheim AS, Sarpatwari A.
Mayo Clin Proc
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Using real-world safety data in regulatory approval decisions: Sotagliflozin and the risk of diabetic ketoacidosis.
Authors: Authors: Fralick M, Kesselheim AS.
Pharmacoepidemiol Drug Saf
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Understanding when real world data can be used to replicate a clinical trial: A cross-sectional study of medications approved in 2011.
Authors: Authors: Fralick M, Bartsch E, Darrow JJ, Kesselheim AS.
Pharmacoepidemiol Drug Saf
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Drug Shortages and the Defense Production Act.
Authors: Authors: Raunig BL, Kesselheim AS, Darrow JJ.
Am J Public Health
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Projected spending for brand-name drugs in English primary care given US prices: a cross-sectional study.
Authors: Authors: Liu M, MacKenna B, Feldman WB, Walker AJ, Avorn J, Kesselheim AS, Goldacre B.
J R Soc Med
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US Spending Associated With Transition From Daily to 3-Times-Weekly Glatiramer Acetate.
Authors: Authors: Rome BN, Tessema FA, Kesselheim AS.
JAMA Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120