Harvard Catalyst Profiles

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Aaron Seth Kesselheim, M.D.

Other Positions

Alice Hersh New Investigator Award
Chair's Research Award
2015 - 2016
Young Mentor Award
Research Leadership Award
Leonard M. Rosen Memorial Research Award
Power List 100: Masters of the Bench

Aaron S. Kesselheim, M.D., J.D., M.P.H., 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. He graduated from Harvard College and received his postgraduate training at the University of Pennsylvania School of Medicine and Law School, and most recently at the Harvard School of Public Health. He is Board Certified in Internal Medicine, and serves as a primary care physician at the Phyllis Jen Center for Primary Care at BWH. His research focuses on the effects of intellectual property laws and regulatory policies on pharmaceutical development, the drug approval process, and the costs, availability, and use of prescription drugs both domestically and in resource-poor settings. He is a member of the New York State Bar and is a Patent Attorney.

Within the Division, Dr. Kesselheim leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research core focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. With over a dozen faculty, post-docs, students, and other researchers, PORTAL is among the largest and most prolific independent academic research centers in the country focused on these topics. In 2013, Dr. Kesselheim was named a Greenwall Faculty Scholar in Bioethics by the Greenwall Foundation, which supports innovative empirical research in bioethics. Dr. Kesselheim’s work has been funded by such organizations as Arnold Ventures, the Robert Wood Johnson Foundation, the FDA, the Edmond J. Safra Center for Ethics at Harvard University, AHRQ, Pew Charitable Trusts, and the Harvard Clinical and Translational Science Center.

Dr. Kesselheim has received wide recognition for his work. In 2012, he was named to the Perspectives Advisory Board of the New England Journal of Medicine. He has testified before Congress on pharmaceutical policy, medical device regulation, and modernizing clinical trials, and served as a consultant for the NIH, USPTO, and numerous state government offices. He is a member of the FDA Peripheral and Central Nervous System Advisory Committee and has been selected to two National Academies of Science, Engineering and Medicine committees (on opioid use and compounded bioidentical hormones). He is the Editor-in-Chief of the Journal of Law, Medicine, and Ethics.

Dr. Kesselheim also is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health, and serves as a core faculty member in the Harvard Medical School Center for Bioethics and a supervisor for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In the Center for Bioethics, he co-teaches a course titled "Health Law, Policy, and Bioethics" for masters-level students each spring and organizes a popular monthly guest expert series called the Health Policy and Bioethics Consortium.

Since 2014, he has taught a popular course on Food and Drug Administration Law at Yale Law School, where he is the Sidley Austin-Robert D. McLean Visiting Professor of Law. In 2019, Dr. Kesselheim and his PORTAL colleagues developed a massive open online course with HarvardX called "FDA and Prescription Drugs: Current Controversies in Context" that has thusfar attracted over 10,000 participants worldwide.

FDA Premarket Approval Supplements and Medical Device Safety and Effectiveness
Summer, 03/01/13 - 12/21/13
Clinical and Regulatory Features of Drugs Not Initially Approved by the US Food and Drug Administration
Full Time/Year Long, 05/01/13 - 04/30/14
Technological innovations in medication packaging to improve patient adherence: a systematic review
Summer, 06/11/12 - 08/10/12
Clinical Equivalence of Generic and Brand-Name Drugs in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Summer, 12/10/07 - 10/19/08
Promoting Medical Innovation: The Case of Coronary Artery Stents
Summer, 06/13/11 - 08/31/11

The research activities and funding listed below are automatically derived from NIH ExPORTER and other sources, which might result in incorrect or missing items. Faculty can login to make corrections and additions.
  1. U01FD004856 (KESSELHEIM, AARON SETH) Sep 15, 2013 - Mar 31, 2015
    Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
    Role: Principal Investigator
  2. K08HS018465 (KESSELHEIM, AARON SETH) Sep 30, 2009 - Jul 31, 2014
    Off-label prescribing: Comparative evidence, regulation, and utilization
    Role: Principal Investigator

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Funded by the NIH National Center for Advancing Translational Sciences through its Clinical and Translational Science Awards Program, grant number UL1TR002541.