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
Generating comparative evidence on new drugs and devices before approval.
Authors: Authors: Naci H, Salcher-Konrad M, Kesselheim AS, Wieseler B, Rochaix L, Redberg RF, Salanti G, Jackson E, Garner S, Stroup TS, Cipriani A.
Lancet
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Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support.
Authors: Authors: Sarpatwari A, LaPidus AK, Kesselheim AS.
Ann Intern Med
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Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary.
Authors: Authors: Feldman WB, Avorn J, Kesselheim AS.
JAMA Intern Med
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New drug approvals in oncology.
Authors: Authors: Kurzrock R, Kantarjian HM, Kesselheim AS, Sigal EV.
Nat Rev Clin Oncol
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Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study.
Authors: Authors: Lin KJ, Dvorin E, Kesselheim AS.
PLoS Med
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FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
JAMA
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US Food and Drug Administration Recommendations on the Use of Surrogate Measures as End Points in New Anti-infective Drug Approvals.
Authors: Authors: Hey SP, Kesselheim AS, Patel P, Mehrotra P, Powers JH.
JAMA Intern Med
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Incentivizing Antibiotic Development: Why Isn't the Generating Antibiotic Incentives Now (GAIN) Act Working?
Authors: Authors: Darrow JJ, Kesselheim AS.
Open Forum Infect Dis
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Correction to: FDA and EMA Biosimilar Approvals.
Authors: Authors: Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS.
J Gen Intern Med
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The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation.
Authors: Authors: Morten CJ, Kesselheim AS, Ross JS.
J Law Med Ethics
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Address: 
Brigham and Women's Hospital
Boston, MA 02120