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 Failure of Solanezumab - How the FDA Saved Taxpayers Billions.
Authors: Authors: Sacks CA, Avorn J, Kesselheim AS.
N Engl J Med
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Medicaid Expenditures and Estimated Rebates for Epinephrine Autoinjectors, 2012 to 2016.
Authors: Authors: Luo J, Kesselheim AS, Avorn J.
JAMA Intern Med
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Media Coverage of FDA Drug Safety Communications about Zolpidem: A Quantitative and Qualitative Analysis.
Authors: Authors: Woloshin S, Schwartz LM, Dejene S, Rausch P, Dal Pan GJ, Zhou EH, Kesselheim AS.
J Health Commun
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Periodic benefit-risk evaluation reports have substantial promise to guide patient care and should be made publicly available.
Authors: Authors: Fralick M, Kesselheim AS.
Pharmacoepidemiol Drug Saf
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Ensuring Access to Injectable Generic Drugs - The Case of Intravesical BCG for Bladder Cancer.
Authors: Authors: Davies BJ, Hwang TJ, Kesselheim AS.
N Engl J Med
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Three design aspects for high quality post-marketing cohort studies.
Authors: Authors: Fralick M, Kesselheim AS.
BMJ
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FDA Approval of Eteplirsen for Muscular Dystrophy-Reply.
Authors: Authors: Kesselheim AS, Avorn J.
JAMA
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Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.
Authors: Authors: Rathi VK, Wang B, Ross JS, Downing NS, Kesselheim AS, Gray ST.
Otolaryngol Head Neck Surg
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Strategies to improve the affordability of insulin in the USA.
Authors: Authors: Luo J, Kesselheim AS, Greene J, Lipska KJ.
Lancet Diabetes Endocrinol
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Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence.
Authors: Authors: Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS.
Drugs
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Address: 
Brigham and Women's Hospital
Boston, MA 02120