Aaron S. Kesselheim, MD, JD, MPH

Aaron S. Kesselheim is a professor of medicine at Harvard Medical School and the Director of the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics in the Department of Medicine at Brigham and Women’s Hospital. 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 around the world. PORTAL, which he founded in 2012, has become among the largest and most prolific academic groups in the US doing work in this area. He was found to be the second-most cited health law scholar in Web of Science from 2013-2017.

Dr. Kesselheim has testified before Congress numerous times on issues such as pharmaceutical policy, medical device regulation, and modernizing clinical trials. 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 consensus committees. He is a member of the Perspectives Advisory Board of the New England Journal of Medicine and the editor-in-chief of the Journal of Law, Medicine, and Ethics. He is the Sidley Austin-Robert D. McLean Visiting Professor of Law at Yale Law School, where he has taught x an annual course on “FDA Law and Policy” (now also at the Yale School of Public Health)  since 2014; he also serves as core faculty at the HMS Center for Bioethics, where he co-teaches a course on “Health Law and Bioethics” and organizes a popular monthly health policy and bioethics consortium seminar series. In 2019, Dr. Kesselheim and his PORTAL colleagues developed a massive open online course (MOOC) 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 12,000 participants from around the world.

For more information, visit: https://www.portalresearch.org/aaron-kesselheim.html

Access to drugs and devices that have limited supporting data: ethical implications for patients and physicians

Grant Cycle: 2012-2013

The FDA faces increasing pressure to approve promising new drugs and medical devices for conditions with no effective treatment in an expeditious manner, even if the detailed evidence of efficacy and safety is not available. Dr. Kesselheim will study the experience with orphan drugs and expanded access programs as a way to analyze how to balance unclear efficacy and unknown risks.