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 FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later.
Authors: Authors: Avorn J, Kesselheim A, Sarpatwari A.
N Engl J Med
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The Tax Cuts and Jobs Act of 2017 and the Pharmaceutical Industry.
Authors: Authors: Sinha MS, Kesselheim AS.
J Law Med Ethics
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Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents.
Authors: Authors: Sacks CA, Lee CC, Kesselheim AS, Avorn J.
JAMA
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The Shortage of Normal Saline in the Wake of Hurricane Maria.
Authors: Authors: Sacks CA, Kesselheim AS, Fralick M.
JAMA Intern Med
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Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
Authors: Authors: Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.
J Clin Oncol
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An Incomplete Prescription: President Trump's Plan to Address High Drug Prices.
Authors: Authors: Sarpatwari A, Avorn J, Kesselheim AS.
JAMA
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Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio.
Authors: Authors: Wang A, Kesselheim AS.
J Law Med Ethics
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Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmacists' Substitution Beliefs and Practices.
Authors: Authors: Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, Jiang W, Campbell EG, Kesselheim AS.
Clin Pharmacol Ther
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Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety.
Authors: Authors: Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS.
J Gen Intern Med
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U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.
Authors: Authors: Lee TT, Kesselheim AS.
Ann Intern Med
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Address: 
Brigham and Women's Hospital
Boston, MA 02120