Aaron S. Kesselheim, MD, JD, MPH

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Director, Program on Regulation, Therapeutics and Law

Brigham & Women’s Hospital
Department of Medicine
Division of Pharmacoepidemiology & Pharmacoeconomics
1620 Tremont Street, Suite 4016
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

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

Brigham and Women’s Hospital Research Leadership Award, 2016

Harvard Medical School Young Mentor Award, 2015-2016

Brigham and Women’s Hospital Chair’s Research Award, 2014

Health Affairs “People and Places,” December 2011Alice S. Hersh New Investigator Award, 2010

Video Features

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.

AJMCtv: Comparative effectiveness research

National Pharmaceutical Council: CER & academic detailing

Podcasts/Radio Interviews

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

This Week in Health Law: Episode 26: Guest Aaron Kesselheim. EHR gag clauses, ACOs, the state of drug safety & price regulation & Kim Kardashian

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

NEJM Group Open Forum: Drug pricing: de-mystifying the power, politics, and practice behind today’s pharmaceutical economy

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”