Aaron Seth Kesselheim
Aaron Seth Kesselheim, M.D.
Professor of Medicine

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.

Publications View
Fool Me Twice? The Reemergence of Rofecoxib and the Orphan Drug Act.
Authors: Authors: Lee TT, Solomon DH, Kesselheim AS.
Ann Intern Med
View full abstract on Pubmed
Variation in Prescription Drug Prices by Retail Pharmacy Type: A National Cross-sectional Study.
Authors: Authors: Luo J, Kulldorff M, Sarpatwari A, Pawar A, Kesselheim AS.
Ann Intern Med
View full abstract on Pubmed
Changes in Price for Generic Drugs in the USA, 2008-2016.
Authors: Authors: Dave CV, Brill G, Kesselheim AS.
J Gen Intern Med
View full abstract on Pubmed
Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey.
Authors: Authors: Kesselheim AS, Sinha MS, Rausch P, Lu Z, Tessema FA, Lappin BM, Zhou EH, Dal Pan GJ, Zwanziger L, Ramanadham A, Loughlin A, Enger C, Avorn J, Campbell EG.
J Law Med Ethics
View full abstract on Pubmed
Challenges and Opportunities for Biomarker Validation.
Authors: Authors: Hey SP, D'Andrea E, Jung EH, Tessema F, Luo J, Gyawali B, Kesselheim AS.
J Law Med Ethics
View full abstract on Pubmed
Potential Medicare Savings From Generic Substitution and Therapeutic Interchange of ACE Inhibitors and Angiotensin-II-Receptor Blockers.
Authors: Authors: Growdon ME, Sacks CA, Kesselheim AS, Avorn J.
JAMA Intern Med
View full abstract on Pubmed
Assessing the Justification, Funding, Success, and Survival Outcomes of Randomized Noninferiority Trials of Cancer Drugs: A Systematic Review and Pooled Analysis.
Authors: Authors: Gyawali B, Tessema FA, Jung EH, Kesselheim AS.
JAMA Netw Open
View full abstract on Pubmed
Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis.
Authors: Authors: Li DG, Najafzadeh M, Kesselheim AS, Mostaghimi A.
BMJ
View full abstract on Pubmed
Impact of State Laws Restricting Opioid Duration on Characteristics of New Opioid Prescriptions.
Authors: Authors: Dave CV, Patorno E, Franklin JM, Huybrechts K, Sarpatwari A, Kesselheim AS, Bateman BT.
J Gen Intern Med
View full abstract on Pubmed
Multimodal Analysis of FDA Drug Safety Communications: Lessons from Zolpidem.
Authors: Authors: Kesselheim AS, Sinha MS, Campbell EG, Schneeweiss S, Rausch P, Lappin BM, Zhou EH, Avorn J, Dal Pan GJ.
Drug Saf
View full abstract on Pubmed

Address: 
Brigham and Women's Hospital
Boston, MA 02120