Aaron S. Kesselheim, MD, JD, MPH

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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 FDA and the Harvard Program in Therapeutic Science.  In the past, he has received research support from the Agency for Healthcare Research and Quality, 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.

In the 2014-2015 academic year, he was a Visiting Associate Professor of Law at Yale Law School, where taught Food and Drug Administration Law.

Selected Publications | Current PubMed Search Results

News Features

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

New York Times (July 2014): Rapid price increases for some generic drugs catch users by surprise

Washington Post (July 2014): FDA has free speech, safety issues to weigh in review of ‘off-label’ marketing rules

New York Times (April 2014): The device maker’s shortcut

USA Today (January 2014): Not all FDA-approved drugs get the same level of testing

New York Times (December 2013): The selling of Attention Deficit Disorder

New York Times (October 2013): For med students, love from the drug rep

New York Times (May 2013): Doctors’ lucrative industry ties

Boston Globe (May 2013): 1 in 4 Mass. physicians received industry gifts

New York Times (Jan 2013): Patients may end pill use if color is altered

CNN (Jan 2013): Don’t judge that generic pill by its color

Boston Magazine (Dec 2012): What’s on your doctor’s mind?

Robert Wood Johnson Human Capital (Oct 2012): Fair and transparent drug company practices needed to protect consumers

New York Times (Oct 2012): Are doctors too wary of drug companies?

AMA News (Oct 2012): Doctors cast skeptical eye on pharma-backed studies

Boston Globe (Sept 2012): Physicians give less credence to studies funded by the pharmaceutical industry

The Economist (Apr 2012): Fraud investigations against drug companies

Rochester Democrat and Chronicle (Jan 2012): Battle over generic drugs leaves doctors, drug companies at odds

New Jersey Star-Ledger (Dec 2011): Effect of fraud prosecutions on off-label drug use

Time Magazine (Nov 2011): Lipitor vs. Crestor

New York Times (Jul 2011): Pills morph as patients try to cope

Selected Awards and Recognitions

Yale School of Management Visiting Scholar, October 2012

Robert Wood Johnson Foundation spotlight “Breaking Ground in New Research” series, January 2012

Health Affairs “People and Places,” December 2011

ASLME Member Spotlight, October 2011

Alice S. Hersh New Investigator Award, 2010

University of Pennsylvania School of Medicine Young Alumnus of the Year, 2008

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

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: 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 Ameet Sarpatwari): Ensuring timely approval of generic drugs

Health Affairs (with Lara Maggs): The short-term and long-term outlook of drug coupons

Health Affairs (with Lara Maggs): The role of black-box warnings in safe prescribing practices

Health Affairs: Health Policy Brief: Biosimilars [supervising editor]

Health Affairs (with Nathan Shiu): FTC v. Actavis: the Supreme Court issues a reversal on reverse payments

Pharmalot (by Harlan Krumholz): A suggestion to restore faith in pharma studies

PLoS (by Jessica Wapner): Industry’s influence 

Scientific American (by Jalees Rehman): Can the source of funding for medical research affect the results?

Robert Wood Johnson Foundation Human Capital Project: Pharmaceutical marketing to medical students

Irrelevant Additional Information

Harvard Lampoon editor

Co-author, book & lyrics, Hasty Pudding Theatricals 149 “Me and My Galaxy”