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
Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period.
Authors: Authors: Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS.
Health Aff (Millwood)
View full abstract on Pubmed
Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem.
Authors: Authors: Luo J, Kesselheim AS.
JAMA Intern Med
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Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health.
Authors: Authors: Sinha MS, Jain N, Hwang T, Kesselheim AS.
Am J Law Med
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The next forum for unraveling FDA off-label marketing rules: State and federal legislatures.
Authors: Authors: Sinha MS, Kesselheim AS.
PLoS Med
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Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Authors: Authors: Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.
Health Aff (Millwood)
View full abstract on Pubmed
Application and impact of run-in studies.
Authors: Authors: Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS.
J Gen Intern Med
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The FDA Breakthrough-Drug Designation - Four Years of Experience.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
N Engl J Med
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Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study.
Authors: Authors: Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ.
BMJ
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Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.
Authors: Authors: Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS.
BMJ
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Legal Challenges to State Drug Pricing Laws.
Authors: Authors: Lee TT, Kesselheim AS, Kapczynski A.
JAMA
View full abstract on Pubmed

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