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
Variations in Patients' Perceptions and Use of Generic Drugs: Results of a National Survey.
Authors: Authors: Kesselheim AS, Gagne JJ, Franklin JM, Eddings W, Fulchino LA, Avorn J, Campbell EG.
J Gen Intern Med
View full abstract on Pubmed
The US Food and Drug Administration 515 Program Initiative: Addressing the Evidence Gap for Widely Used, High-Risk Cardiovascular Devices?
Authors: Authors: Rathi VK, Kesselheim AS, Ross JS.
JAMA Cardiol
View full abstract on Pubmed
Leveraging Novel and Existing Pathways to Approve New Therapeutics to Treat Serious Drug-Resistant Infections.
Authors: Authors: Hwang TJ, Kesselheim AS.
Am J Law Med
View full abstract on Pubmed
Brief Report: Utilization of the First Biosimilar Infliximab Since Its Approval in South Korea.
Authors: Authors: Kim SC, Choi NK, Lee J, Kwon KE, Eddings W, Sung YK, Ji Song H, Kesselheim AS, Solomon DH.
Arthritis Rheumatol
View full abstract on Pubmed
'Government Patent Use': A Legal Approach To Reducing Drug Spending.
Authors: Authors: Kapczynski A, Kesselheim AS.
Health Aff (Millwood)
View full abstract on Pubmed
Efficacy of the Priority Review Voucher Program.
Authors: Authors: Sarpatwari A, Kesselheim AS.
JAMA
View full abstract on Pubmed
Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation.
Authors: Authors: Kesselheim AS, Woloshin S, Eddings W, Franklin JM, Ross KM, Schwartz LM.
JAMA
View full abstract on Pubmed
Breakthrough Medical Devices and the 21st Century Cures Act.
Authors: Authors: Kesselheim AS, Hwang TJ.
Ann Intern Med
View full abstract on Pubmed
Drug Product Life-Cycle Management as Anticompetitive Behavior: The Case of Memantine.
Authors: Authors: Capati VC, Kesselheim AS.
J Manag Care Spec Pharm
View full abstract on Pubmed
An Uninformative Truth: The Logic of Amarin's Off-Label Promotion.
Authors: Authors: Hey SP, Kesselheim AS.
PLoS Med
View full abstract on Pubmed

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