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
Lessons From The Impact Of Price Regulation On The Pricing Of Anticancer Drugs In Germany.
Authors: Authors: Lauenroth VD, Kesselheim AS, Sarpatwari A, Stern AD.
Health Aff (Millwood)
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Regulatory approval characteristics of antimicrobial versus non-antimicrobial products, 1984-2018: an evaluation of Food and Drug Administration flexibilities.
Authors: Authors: Darrow JJ, Najafzadeh M, Stefanini K, Kesselheim AS.
Lancet Infect Dis
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Novelty of Active Ingredients in High-Cost Brand-Name Drugs.
Authors: Authors: Jung EH, Sarpatwari A, Kesselheim AS.
J Gen Intern Med
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Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018.
Authors: Authors: Barenie RE, Gagne JJ, Kesselheim AS, Pawar A, Tong A, Luo J, Bateman BT.
Drug Saf
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Reconsidering the scope of US state laws allowing pharmacist substitution of generic drugs.
Authors: Authors: Darrow JJ, Chong JE, Kesselheim AS.
BMJ
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Specialty Drugs - A Distinctly American Phenomenon.
Authors: Authors: Naci H, Kesselheim AS.
N Engl J Med
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FDA and EMA Biosimilar Approvals.
Authors: Authors: Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.
J Gen Intern Med
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Estimating The Cost Of Delayed Generic Drug Entry To Medicaid.
Authors: Authors: Dave CV, Sinha MS, Beall RF, Kesselheim AS.
Health Aff (Millwood)
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The evidence landscape in precision medicine.
Authors: Authors: Hey SP, Gerlach CV, Dunlap G, Prasad V, Kesselheim AS.
Sci Transl Med
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A Systematic Review and Meta-Analysis of Bevacizumab in First-Line Metastatic Breast Cancer: Lessons for Research and Regulatory Enterprises.
Authors: Authors: Hey SP, Gyawali B, D'Andrea E, Kanagaraj M, Franklin JM, Kesselheim AS.
J Natl Cancer Inst
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Address: 
Brigham and Women's Hospital
Boston, MA 02120