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, 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 co-director of the Harvard-MIT Center for Regulatory Science, 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.
Since 2014, he has been the Irving S Ribicoff Visiting Associate Professor of Law at Yale Law School, where he teaches a popular course on Food and Drug Administration 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 attracted over 6000 participants worldwide.