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
The 21st Century Cures Act--Will It Take Us Back in Time?
Authors: Authors: Avorn J, Kesselheim AS.
N Engl J Med
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Progress and Hurdles for Follow-on Biologics.
Authors: Authors: Sarpatwari A, Avorn J, Kesselheim AS.
N Engl J Med
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Methodological approaches to evaluate the impact of FDA drug safety communications.
Authors: Authors: Kesselheim AS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Seeger JD, Brownstein JS, Woloshin S, Schwartz LM, Toomey T, Dal Pan GJ, Avorn J.
Drug Saf
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Accelerating innovation in rapid diagnostics and targeted antibacterials.
Authors: Authors: Hwang TJ, Powers JH, Carpenter D, Kesselheim AS.
Nat Biotechnol
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Precision medicine and the FDA's draft guidance on laboratory-developed tests.
Authors: Authors: Hwang TJ, Lehmann LS, Kesselheim AS.
Nat Biotechnol
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Expanded access to investigational drugs.
Authors: Authors: Sarpatwari A, Darrow JJ, Kesselheim AS.
N Engl J Med
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Variations in time of market exclusivity among top-selling prescription drugs in the United States.
Authors: Authors: Wang B, Liu J, Kesselheim AS.
JAMA Intern Med
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Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes.
Authors: Authors: Kesselheim AS, Polinski JM, Fulchino LA, Isaman DL, Gagne JJ.
Drugs
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The Watchman saga--closure at last?
Authors: Authors: Kramer DB, Kesselheim AS.
N Engl J Med
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Mandatory disclaimers on dietary supplements do not reliably communicate the intended issues.
Authors: Authors: Kesselheim AS, Connolly J, Rogers J, Avorn J.
Health Aff (Millwood)
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Address: 
Brigham and Women's Hospital
Boston, MA 02120