Aaron S. Kesselheim, MD, JD, MPH
Brigham & Women’s Hospital
Department of Medicine
Division of Pharmacoepidemiology & Pharmacoeconomics
1620 Tremont Street, Suite 3030
Boston, MA 02120
Phone: 617-278-0930 | Fax: 617-232-8602
Aaron S. Kesselheim, M.D., J.D., M.P.H., is an Associate 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 has also investigated how other issues at the intersection of law and public health can affect the health care system, including health care fraud, expert testimony in malpractice cases, and insurance reimbursement practices. 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. 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 the Laura and John Arnold Foundation and the Harvard Program in Therapeutic Science. 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 on pharmaceutical policy, medical device regulation, generic drugs, and modernizing clinical trials, and served as a consultant for the NIH, FDA, Institute of Medicine, USPTO, and numerous state government offices. He has been a visiting scholar at the Yale School of Medicine and School of Management. In 2010, he received the prestigious Alice S. Hersh New Investigator Award from AcademyHealth, the leading professional organization for health services/policy research. The Hersh award is given annually to an outstanding health services researcher under age 40 in the US.
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 Visiting Associate Professor of Law at Yale Law School, where taught Food and Drug Administration Law in 2014-2015 and 2016-2017. In 2017-2018, his FDA Law and Policy course will be co-listed with the Yale School of Public Health and Yale Medical School.
Selected Publications (from >300) | Current PubMed Search Results
- Kesselheim AS, Rome BN, Sarpatwari A, Avorn J. Six-month market exclusivity extensions to promote research offer substantial returns for many drug makers. Health Affairs 2017;36(2):362-370.
- Sacks CA, Avorn J, Kesselheim AS. The failure of solanezumab—how the FDA saved taxpayers billions. New England Journal of Medicine 2017;376(18):1706-1708.
- Fralick M, Kesselheim AS. FDA approval of desmopressin for nocturia. JAMA 2017;317(20):2059-2060.
- Hey SP, Kesselheim AS. The FDA, Juno Therapeutics, and the ethical imperative of transparency. BMJ 2016;354:i4435.
- Kesselheim AS, Treasure CL, Joffe S. Biomarker-defined subsets of common diseases: policy and economic implications of Orphan Drug Act coverage. PLoS Medicine 2017;14(1):e1002190.
- Kesselheim AS, Avorn J, Sarpatwari A. The high cost of prescription drugs in the United States: origins and prospects for reform. JAMA 2016;316(8):858-871.
- Kesselheim AS, Hwang TJ. Breakthrough medical devices and the 21st Century Cures Act. Annals of Internal Medicine 2016;164(7):500-502.
- Kesselheim AS, Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ 2015;351:h4679.
- Kesselheim AS, Tan YT, Avorn J. The roles of academia, rare diseases, and repurposing in the development of the most transformative drugs. Health Affairs 2015;34:286-294.
- Kesselheim AS, Connolly JC, Rogers J, Avorn J. Despite mandatory disclaimers on dietary supplements, many consumers remains unaware or overlook the information. Health Affairs 2015;34(3):438-446
- Kesselheim AS, Darrow JJ. Hatch-Waxman turns 30: Do we need a redesigned approach for the modern era? Yale J Health Policy, Law and Ethics 2015;15(2):293-347.
- Sharfstein JM, Kesselheim AS. The safety of prescription drugs. JAMA 2015;314(3):233-234.
- Avorn J, Kesselheim AS. The 21st Century Cures Act — will it take us back in time? New England Journal of Medicine 2015;372(26):2473-5.
- Hwang TJ, Carpenter D, Kesselheim AS. Paying for innovation: reimbursement incentives for antibiotics. Science Translational Medicine 2015;7(276):276fs9.
- Darrow JJ, Sarpatwari A, Avorn J, Kesselheim AS. Practical, legal, and ethical issues in expanded access to investigational drugs. New England Journal of Medicine 2015;372(3):279-86.
- Rome BN, Kramer DB, Kesselheim AS. FDA approval of cardiac implantable electrical devices via original and supplement pre-market approval pathways, 1979-2012. JAMA 2014;311(4):385-91.
- Kesselheim AS, Cook-Deegan RM, Winickoff DE, Mello MM. Gene patenting – the Supreme Court finally speaks. New England Journal of Medicine 2013;369(9):869-75.
- Kesselheim AS, Bykov K, Avorn J, Tong A, Doherty M, Choudhry NK. Burdens of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies. Annals of Internal Medicine 2014;161(2):96-103.
- Kesselheim AS, Robertson CT, Myers JA, Rose SL, Gillet V, Ross KM, Glynn RJ, Joffe S, Avorn J. A randomized study of how physicians interpret research funding disclosures. New England Journal of Medicine 2012;367(12):1119-1127.
Selected News Features
New York Times (Apr 2017): Defiant, generic drug maker continues to raise prices
STAT News (Feb 2017): Q&A: 21st Century Cures Act may favor ‘speed over science’
Washington Post (Nov 2016): Congress set to vote on bill that promises to speed up drug approval
Science Magazine (Dec 2016): Under 21st Century Cures legislation, stem cell advocates expect regulatory short cuts
New York Times (Sept 2016): The lesson of EpiPens: why drug prices spike, again and again
New York Times (Sept 2015): F.D.A. nominee Califf’s ties to drug makers worry some
New York Times (May 2015): Company creates bioethics panel on trial drugs
New York Times (May 2015): Speedy drug approvals have become the rule, not the exception
Selected Awards and Recognitions
Harvard Medical School Young Mentor Award, 2015-2016
Brigham and Women’s Hospital Chair’s Research Award, 2014
CBS Evening News: Why some generic drug prices are skyrocketing
PRI’s The World/Forum at Harvard School of Public Health: Battling Drug-Resistant Superbugs: Can We Win?
Medpage Today: Big changes to heart devices OK’d without new data
New York Times website: How pharmaceutical companies sell A.D.H.D.
National Pharmaceutical Council: CER & academic detailing
STAT Signal podcast: The death of a child and a golden ticket for drug makers
PRI’s The World Science Friday with Ira Flatow: Why generic doesn’t mean cheap
British Medical Journal: High risk devices for rare conditions
Robert Wood Johnson Foundation Human Capital Project: Intellectual property and health care delivery
JournalWatch: FDA approval of colchicine
JournalWatch: Brand-name and generic drug bioequivalence
Relevant Blog Posts
Health Affairs (with Thomas Hwang): Taxing drug price spikes: assessing the impact
Health Affairs: Health Policy Brief: The FDA’s Sentinel Initiative [supervising editor]
Health Affairs (with Ameet Sarpatwari): To spur medical innovation, make corporate cheaters pay
Health Affairs (with Lara Maggs): The role of black-box warnings in safe prescribing practices
Health Affairs: Health Policy Brief: Biosimilars [supervising editor]
Irrelevant Additional Information
Harvard Lampoon editor
Co-author, book & lyrics, Hasty Pudding Theatricals 149 “Me and My Galaxy”