Harvard Catalyst Profiles

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Aaron Seth Kesselheim, M.D.


Alice Hersh New Investigator Award
Chair's Research Award
2015 - 2016
Young Mentor Award
Research Leadership Award
Leonard M. Rosen Memorial Research Award
Power List 100: Masters of the Bench

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 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. With over a dozen faculty, post-docs, students, and other researchers, PORTAL is among the largest and most prolific independent academic research centers in the country focused on these topics. 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 has been funded by such organizations as Arnold Ventures, the Robert Wood Johnson Foundation, the FDA, the Edmond J. Safra Center for Ethics at Harvard University, AHRQ, 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, and modernizing clinical trials, and served as a consultant for the NIH, 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 two National Academies of Science, Engineering and Medicine committees (on opioid use and compounded bioidentical hormones). He is the Editor-in-Chief of the Journal of Law, Medicine, and Ethics.

Dr. Kesselheim also is a Research Associate in the Department of Health Policy and Management at the Harvard School of Public Health, and serves as a core faculty member in the Harvard Medical School Center for Bioethics and a supervisor for the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. In the Center for Bioethics, he co-teaches a course titled "Health Law, Policy, and Bioethics" for masters-level students each spring and organizes a popular monthly guest expert series called the Health Policy and Bioethics Consortium.

Since 2014, he has taught a popular course on Food and Drug Administration Law at Yale Law School, where he is the Sidley Austin-Robert D. McLean Visiting Professor of Law. In 2019, Dr. Kesselheim and his PORTAL colleagues developed a massive open online course with HarvardX called "FDA and Prescription Drugs: Current Controversies in Context" that has thusfar attracted over 10,000 participants worldwide.

FDA Premarket Approval Supplements and Medical Device Safety and Effectiveness
Summer, 03/01/13 - 12/21/13
Clinical and Regulatory Features of Drugs Not Initially Approved by the US Food and Drug Administration
Full Time/Year Long, 05/01/13 - 04/30/14
Technological innovations in medication packaging to improve patient adherence: a systematic review
Summer, 06/11/12 - 08/10/12
Clinical Equivalence of Generic and Brand-Name Drugs in Cardiovascular Disease: A Systematic Review and Meta-Analysis
Summer, 12/10/07 - 10/19/08
Promoting Medical Innovation: The Case of Coronary Artery Stents
Summer, 06/13/11 - 08/31/11

The research activities and funding listed below are automatically derived from NIH ExPORTER and other sources, which might result in incorrect or missing items. Faculty can login to make corrections and additions.
  1. U01FD004856 (KESSELHEIM, AARON SETH) Sep 15, 2013 - Sep 14, 2014
    Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
    Role: Principal Investigator
  2. K08HS018465 (KESSELHEIM, AARON SETH) Sep 30, 2009 - Jul 31, 2014
    Off-label prescribing: Comparative evidence, regulation, and utilization
    Role: Principal Investigator

Featured Content

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.
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PMC Citations indicate the number of times the publication was cited by articles in PubMed Central, and the Altmetric score represents citations in news articles and social media. (Note that publications are often cited in additional ways that are not shown here.) Fields are based on how the National Library of Medicine (NLM) classifies the publication's journal and might not represent the specific topic of the publication. Translation tags are based on the publication type and the MeSH terms NLM assigns to the publication. Some publications (especially newer ones and publications not in PubMed) might not yet be assigned Field or Translation tags.) Click a Field or Translation tag to filter the publications.
  1. Hey SP, Gerlach CV, Dunlap G, Prasad V, Kesselheim AS. The evidence landscape in precision medicine. Sci Transl Med. 2020 Apr 22; 12(540). PMID: 32321867.
  2. Vreman RA, Naci H, Goettsch WG, Mantel-Teeuwisse AK, Schneeweiss SG, Leufkens HGM, Kesselheim AS. Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe. Clin Pharmacol Ther. 2020 Apr 01. PMID: 32236959.
  3. Lin KJ, Dvorin E, Kesselheim AS. Prescribing systemic steroids for acute respiratory tract infections in United States outpatient settings: A nationwide population-based cohort study. PLoS Med. 2020 Mar; 17(3):e1003058. PMID: 32231363.
  4. Barenie RE, Gagne JJ, Kesselheim AS, Pawar A, Tong A, Luo J, Bateman BT. Rates and Costs of Dispensing Naloxone to Patients at High Risk for Opioid Overdose in the United States, 2014-2018. Drug Saf. 2020 Mar 16. PMID: 32180134.
  5. Rome BN, Kesselheim AS. Federal Spending on Off-Patent Drugs That Lack Generic Competition. J Gen Intern Med. 2020 Mar 06. PMID: 32144695.
  6. Sarpatwari A, LaPidus AK, Kesselheim AS. Revisiting the National Institutes of Health Fair Pricing Condition: Promoting the Affordability of Drugs Developed With Government Support. Ann Intern Med. 2020 Mar 03; 172(5):348-350. PMID: 31986528.
  7. Darrow JJ, Avorn J, Kesselheim AS. FDA Approval and Regulation of Pharmaceuticals, 1983-2018. JAMA. 2020 01 14; 323(2):164-176. PMID: 31935033.
  8. Jung EH, Sarpatwari A, Kesselheim AS. Novelty of Active Ingredients in High-Cost Brand-Name Drugs. J Gen Intern Med. 2020 Jan 02. PMID: 31898115.
  9. Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. Correction to: FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2019 Dec 05. PMID: 31808127.
  10. Feldman WB, Avorn J, Kesselheim AS. Potential Medicare Savings on Inhaler Prescriptions Through the Use of Negotiated Prices and a Defined Formulary. JAMA Intern Med. 2019 Dec 02. PMID: 31790541.
  11. Jung EH, Sarpatwari A, Kesselheim AS, Sinha MS. FDA and EMA Biosimilar Approvals. J Gen Intern Med. 2019 Dec 02. PMID: 31637641.
  12. Morten CJ, Kesselheim AS, Ross JS. The Supreme Court's Latest Ruling on Drug Liability and its Implications for Future Failure-to-Warn Litigation. J Law Med Ethics. 2019 Dec; 47(4):783-787. PMID: 31957583.
  13. Schwartz LM, Woloshin S, Lu Z, Ross KM, Tessema FA, Peter D, Kesselheim AS. Randomized Study of Providing Evidence Context to Mitigate Physician Misinterpretation Arising From Off-Label Drug Promotion. Circ Cardiovasc Qual Outcomes. 2019 Nov; 12(11):e006073. PMID: 31707825.
  14. Hwang TJ, Sinha MS, Dave CV, Kesselheim AS. Prescription Opioid Epidemic and Trends in the Clinical Development of New Pain Medications. Mayo Clin Proc. 2019 12; 94(12):2437-2443. PMID: 31685265.
  15. Fischer MA, Kesselheim AS, Lu Z, Ross KM, Tessema FA, Avorn J. Physician Perceptions of Step Therapy Prescribing Requirements. J Manag Care Spec Pharm. 2019 Nov; 25(11):1210-1224.