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 created and 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. PORTAL has become one of the largest and most prolific independent research centers in the country that addresses these issues. In 2013, Dr. Kesselheim was selected as a Greenwall Faculty Scholar in Bioethics. Dr. Kesselheim’s work is also currently funded by Arnold Ventures, the Harvard-MIT Center for Regulatory Science, and the Engelberg Foundation. In the past, he has received research support from the Agency for Healthcare Research and Quality, the FDA, a Robert Wood Johnson Investigator Award in Health Policy Research, the Edmond J. Safra Center for Ethics at Harvard University, 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 a half-dozen times on pharmaceutical policy, medical device regulation, generic drugs, 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 appointed to committees for the National Academies of Science, Engineering, and Medicine on opioid prescribing and compounded bioidentical hormone therapy. He is the editor-in-chief of the Journal of Law, Medicine, and Ethics.
Dr. Kesselheim also serves as a faculty supervisor for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, a faculty member of the Harvard Center for Bioethics, and a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health.
He has been appointed a Sidley Austin-Robert D. McLean Visiting Professor of Law at Yale Law School, where he has taught a popular annual course on Food and Drug Administration Law since 2015. He is also a distinguished visitor at the Solomon Center for Health Law and Policy at Yale.
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 EdX education portal. To date, it has attracted over 10,000 participants from around the world.