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
Evidence Required for Drugs Granted Accelerated Approval-Reply.
Authors: Authors: Naci H, Kesselheim AS.
JAMA
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Will inter partes review speed US generic drug entry?
Authors: Authors: Darrow JJ, Beall RF, Kesselheim AS.
Nat Biotechnol
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Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
N Engl J Med
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The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
Authors: Authors: Hwang TJ, Darrow JJ, Kesselheim AS.
JAMA
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Trends in Pricing and Generic Competition Within the Oral Antibiotic Drug Market in the United States.
Authors: Authors: Alpern JD, Zhang L, Stauffer WM, Kesselheim AS.
Clin Infect Dis
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Determinants of Market Exclusivity for Prescription Drugs in the United States.
Authors: Authors: Kesselheim AS, Sinha MS, Avorn J.
JAMA Intern Med
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Strategies That Delay Market Entry of Generic Drugs.
Authors: Authors: Vokinger KN, Kesselheim AS, Avorn J, Sarpatwari A.
JAMA Intern Med
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The Price of Crossing the Border for Medications.
Authors: Authors: Fralick M, Avorn J, Kesselheim AS.
N Engl J Med
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The Price of Crossing the Border for Medications.
Authors: Authors: Fralick M, Avorn J, Kesselheim AS.
N Engl J Med
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Low-Dose Desmopressin Nasal Spray and FDA Approval-Reply.
Authors: Authors: Fralick M, Kesselheim AS.
JAMA
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Address: 
Brigham and Women's Hospital
Boston, MA 02120