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
Post-Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004-2014.
Authors: Authors: Cherla A, Mossialos E, Salcher-Konrad M, Kesselheim AS, Naci H.
Clin Pharmacol Ther
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Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD.
Authors: Authors: Feldman WB, Bloomfield D, Beall RF, Kesselheim AS.
Nat Biotechnol
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Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia.
Authors: Authors: Hwang TJ, Kesselheim AS, Tibau A, Lee CC, Vokinger KN.
JCO Oncol Pract
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Improving the Use of FDA Advisory Committees.
Authors: Authors: Daval CJR, Kesselheim AS, Sarpatwari A.
N Engl J Med
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What to Know About the Alzheimer Drug Aducanumab (Aduhelm).
Authors: Authors: Woloshin S, Kesselheim AS.
JAMA Intern Med
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Characteristics Of Key Patents Covering Recent FDA-Approved Drugs.
Authors: Authors: Van de Wiele VL, Torrance AW, Kesselheim AS.
Health Aff (Millwood)
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The Vexing Voyage of Vasopressin: The Consequences of Granting Market Exclusivity to Unapproved Drugs.
Authors: Authors: Bendicksen L, Kesselheim AS, Rome BN.
Chest
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Government Patent Use to Promote Public Health in the United States: Overcoming Nonpatent Exclusivities.
Authors: Authors: Wolitz RE, Kesselheim AS, Darrow JJ.
Am J Public Health
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The History of Health Law in the United States.
Authors: Authors: Fuse Brown EC, Kesselheim AS.
N Engl J Med
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Over-the-Counter Availability of Rescue Inhalers for Asthma-Reply.
Authors: Authors: Feldman WB, Avorn J, Kesselheim AS.
JAMA
View full abstract on Pubmed

Address: 
Brigham and Women's Hospital
Boston, MA 02120