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 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
- 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.
- Kesselheim AS, Murtagh L, Mello MM. The controversy over “pay-for-delay” settlements of disputes over pharmaceutical patents. New England Journal of Medicine 2011;365(15):1439-1445.
- Kesselheim AS. An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences. Milbank Quarterly 2011;89(3):450-502.
- Kesselheim AS, Myers JA, Avorn J. Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer. JAMA 2011;305:2320-2326.
- Kesselheim AS and Outterson MK. Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law & Ethics 2011;11:101-167.
- Kesselheim AS, Studdert DM, Mello MM. Whistle-blowers’ experiences in fraud litigation against pharmaceutical companies. New England Journal of Medicine 2010;362:1832-1839.
- Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. The clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2009;300:2514-2526.
- Kesselheim AS and Avorn J. Pharmaceutical promotion to physicians and First Amendment rights. New England Journal of Medicine 2008;358:1727-1732.
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
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
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: 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”