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
Pre-market development times for biologic versus small-molecule drugs.
Authors: Authors: Beall RF, Hwang TJ, Kesselheim AS.
Nat Biotechnol
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The Impact Of Price Regulation On The Availability Of New Drugs In Germany.
Authors: Authors: Stern AD, Pietrulla F, Herr A, Kesselheim AS, Sarpatwari A.
Health Aff (Millwood)
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Trust and transparency in medical device regulation.
Authors: Authors: Kramer DB, Kesselheim AS.
BMJ
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Landscape of Cardiovascular Device Registries in the United States.
Authors: Authors: Rajan PV, Holtzman JN, Kesselheim AS, Yeh RW, Kramer DB.
J Am Heart Assoc
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Orphan Drug Designation and Exclusivity for "Same Drugs".
Authors: Authors: Hong P, Sarpatwari A, Kesselheim AS.
J Law Med Ethics
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Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return?
Authors: Authors: Bollyky T, Kesselheim AS.
N Engl J Med
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Physicians' Perspectives on FDA Approval Standards and Off-label Drug Marketing.
Authors: Authors: Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM.
JAMA Intern Med
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Cost Implications of Escalating Intravenous Acetaminophen Use in Children.
Authors: Authors: Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG.
JAMA Pediatr
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US Food and Drug Administration Approval of New Drugs Based on Noninferiority Trials in Oncology: A Dangerous Precedent?
Authors: Authors: Gyawali B, Kesselheim AS.
JAMA Oncol
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Experiences With and Challenges Afforded by Expedited Regulatory Pathways.
Authors: Authors: Liu S, Kesselheim AS.
Clin Pharmacol Ther
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Address: 
Brigham and Women's Hospital
Boston, MA 02120