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
Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study.
Authors: Authors: Mostaghim SR, Gagne JJ, Kesselheim AS.
BMJ
View full abstract on Pubmed
Influence, integrity, and the FDA: An ethical framework.
Authors: Authors: Hey SP, Cohen IG, Adashi EY, Kesselheim AS.
Science
View full abstract on Pubmed
Outcomes-Based Pharmaceutical Contracts: An Answer to High U.S. Drug Spending?
Authors: Authors: Seeley E, Kesselheim AS.
Issue Brief (Commonw Fund)
View full abstract on Pubmed
Value-Based Pricing and State Reform of Prescription Drug Costs.
Authors: Authors: Hwang TJ, Kesselheim AS, Sarpatwari A.
JAMA
View full abstract on Pubmed
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Authors: Authors: Naci H, Smalley KR, Kesselheim AS.
JAMA
View full abstract on Pubmed
Both Urgency and Balance Needed in Addressing Opioid Epidemic: A Report From the National Academies of Sciences, Engineering, and Medicine.
Authors: Authors: Bonnie RJ, Kesselheim AS, Clark DJ.
JAMA
View full abstract on Pubmed
Effect of US Food and Drug Administration's Cardiovascular Safety Guidance on Diabetes Drug Development.
Authors: Authors: Hwang TJ, Franklin JM, Kesselheim AS.
Clin Pharmacol Ther
View full abstract on Pubmed
High Generic Drug Prices and Market Competition: A Retrospective Cohort Study.
Authors: Authors: Dave CV, Kesselheim AS, Fox ER, Qiu P, Hartzema A.
Ann Intern Med
View full abstract on Pubmed
Challenges in the Development of Novel Cardiovascular Therapies.
Authors: Authors: Hwang TJ, Kesselheim AS.
Clin Pharmacol Ther
View full abstract on Pubmed
The Price of Crossing the Border for Medications.
Authors: Authors: Fralick M, Avorn J, Kesselheim AS.
N Engl J Med
View full abstract on Pubmed

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