Aaron Seth Kesselheim, M.D.

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 founded and leads the Program On Regulation, Therapeutics, And Law (PORTAL), an interdisciplinary research center focusing on intersections among prescription drugs and medical devices, patient health outcomes, and regulatory practices and the law. 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 is also currently funded by Arnold Ventures and the Harvard-MIT Center for Regulatory Science. In the past, he has received research support from the Edmond J. Safra Center for Ethics at Harvard University, AHRQ, Pew Charitable Trusts, a Robert Wood Johnson Investigator Award, the Commonwealth Fund, 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, FDA, 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 2 National Academies of Science, Engineering and Medicine consensus committees on the opioid epidemic and compounded bioidentical hormone use. He is the editor-in-chief of the Journal of Law, Medicine, and Ethics.
Dr. Kesselheim serves as a core faculty member in the Harvard Medical School Center for Bioethics. In the Center for Bioethics, he co-teaches a course titled "Health Law, Policy, and Bioethics" for masters-level students each spring. He also organizes the year-long “Health Policy and Bioethics Consortium,” which brings together international experts on a variety of cutting edge topics.
He is the Irving S. Ribicoff Visiting Professor of Law at Yale Law School, where he has taught since 2014 an annual course on Food and Drug Administration Law. In 2019, Dr. Kesselheim and his PORTAL colleagues developed a massive open online course called “FDA and Prescription Drugs: Current Controversies in Context” that was made freely available via the HarvardX education portal. To date, it has attracted over 6000 participants from around the world.