Harvard Catalyst Profiles

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Aaron Seth Kesselheim, M.D.

Title
Institution
Department
Address
Phone
Fax

Biography
2010
Alice Hersh New Investigator Award
2014
Chair's Research Award
2015 - 2016
Young Mentor Award
2016
Research Leadership Award

Overview
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, 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 co-director of the Harvard-MIT Center for Regulatory Science, 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.

Since 2014, he has been the Irving S Ribicoff Visiting Associate Professor of Law at Yale Law School, where he teaches a popular course on Food and Drug Administration 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 attracted over 6000 participants worldwide.

Mentoring
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

Research
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
    FDA
    Assessing Clinical Equivalence for Generic Drugs Approved By Innovative Methods
    Role: Principal Investigator
  2. K08HS018465 (KESSELHEIM, AARON SETH) Sep 30, 2009 - Jul 31, 2014
    AHRQ
    Off-label prescribing: Comparative evidence, regulation, and utilization
    Role: Principal Investigator

Bibliographic
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. Dave CV, Brill G, Kesselheim AS. Changes in Price for Generic Drugs in the USA, 2008-2016. J Gen Intern Med. 2019 May 07. PMID: 31065948.
    Citations:    
  2. Bollyky T, Kesselheim AS. Pharmaceutical Protections in U.S. Trade Deals - What Do Americans Get in Return? N Engl J Med. 2019 May 23; 380(21):1993-1995. PMID: 31042823.
    Citations:    
  3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly JG, Fischer MA, Kesselheim AS, Gagne JJ. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019 Mar; 16(3):e1002763. PMID: 30865626.
    Citations:    
  4. Bourgeois FT, Graham DA, Kesselheim AS, Randolph AG. Cost Implications of Escalating Intravenous Acetaminophen Use in Children. JAMA Pediatr. 2019 Mar 11. PMID: 30855654.
    Citations:    
  5. Hwang TJ, Bourgeois FT, Franklin JM, Kesselheim AS. Impact Of The Priority Review Voucher Program On Drug Development For Rare Pediatric Diseases. Health Aff (Millwood). 2019 Feb; 38(2):313-319. PMID: 30715972.
    Citations:    
  6. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Internal Medicine Physicians' Financial Relationships with Industry: An Updated National Estimate. J Gen Intern Med. 2019 Feb; 34(2):195-197. PMID: 30291605.
    Citations:    Fields:    
  7. Darrow JJ, Beall RF, Kesselheim AS. The Generic Drug Industry Embraces a Faster, Cheaper Pathway for Challenging Patents. Appl Health Econ Health Policy. 2019 Feb; 17(1):47-54. PMID: 30141133.
    Citations:    Fields:    
  8. Kesselheim AS, Woloshin S, Lu Z, Tessema FA, Ross KM, Schwartz LM. Physicians' Perspectives on FDA Approval Standards and Off-Label Drug Marketing. JAMA Intern Med. 2019 Jan 22. PMID: 30667474.
    Citations:    Fields:    
  9. Sarpatwari A, Gagne JJ, Lu Z, Campbell EG, Carman WJ, Enger CL, Dutcher SK, Jiang W, Kesselheim AS. A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications. J Gen Intern Med. 2019 Mar; 34(3):420-428. PMID: 30632102.
    Citations:    Fields:    
  10. Rogers JR, Sarpatwari A, Desai RJ, Bohn JM, Khan NF, Kesselheim AS, Fischer MA, Gagne JJ, Connolly JG. Effect of Lawyer-Submitted Reports on Signals of Disproportional Reporting in the Food and Drug Administration's Adverse Event Reporting System. Drug Saf. 2019 01; 42(1):85-93. PMID: 30066315.
    Citations:    Fields:    
  11. Sarpatwari A, Barenie R, Curfman G, Darrow JJ, Kesselheim AS. The US Biosimilar Market: Stunted Growth and Possible Reforms. Clin Pharmacol Ther. 2019 Jan; 105(1):92-100. PMID: 30415479.
    Citations:    Fields:    
  12. Mundkur ML, Franklin J, Huybrechts KF, Fischer MA, Kesselheim AS, Linder JA, Landon J, Patorno E. Changes in Outpatient Use of Antibiotics by Adults in the United States, 2006-2015. Drug Saf. 2018 12; 41(12):1333-1342. PMID: 29987757.
    Citations:    Fields:    
  13. Sinha MS, Najafzadeh M, Rajasingh EK, Love J, Kesselheim AS. Labeling Changes and Costs for Clinical Trials Performed Under the US Food and Drug Administration Pediatric Exclusivity Extension, 2007 to 2012. JAMA Intern Med. 2018 Nov 01; 178(11):1458-1466. PMID: 30264138.
    Citations:    
  14. Feldman WB, Hey SP, Kesselheim AS. A Systematic Review Of The Food And Drug Administration's 'Exception From Informed Consent' Pathway. Health Aff (Millwood). 2018 10; 37(10):1605-1614. PMID: 30273035.
    Citations:    Fields:    
  15. Gyawali B, Kesselheim AS. Reinforcing the social compromise of accelerated approval. Nat Rev Clin Oncol. 2018 10; 15(10):596-597. PMID: 29970919.
    Citations:    Fields:    
  16. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007 - Assessing Its Effects a Decade Later. N Engl J Med. 2018 Sep 20; 379(12):1097-1099. PMID: 30231220.
    Citations:    Fields:    
  17. Hernandez I, Sampathkumar S, Good CB, Kesselheim AS, Shrank WH. Changes in Drug Pricing After Drug Shortages in the United States. Ann Intern Med. 2018 Sep 18. PMID: 30242373.
    Citations:    Fields:    
  18. Sacks CA, Lee CC, Kesselheim AS, Avorn J. Medicare Spending on Brand-name Combination Medications vs Their Generic Constituents. JAMA. 2018 08 21; 320(7):650-656. PMID: 30140875.
    Citations:    Fields:    
  19. Beall RF, Darrow JJ, Kesselheim AS. Patent term restoration for top-selling drugs in the United States. Drug Discov Today. 2019 01; 24(1):20-25. PMID: 30055271.
    Citations:    Fields:    
  20. Sacks CA, Kesselheim AS, Fralick M. The Shortage of Normal Saline in the Wake of Hurricane Maria. JAMA Intern Med. 2018 07 01; 178(7):885-886. PMID: 29799949.
    Citations:    Fields:    
  21. Sarpatwari A, Avorn J, Kesselheim AS. An Incomplete Prescription: President Trump's Plan to Address High Drug Prices. JAMA. 2018 06 19; 319(23):2373-2374. PMID: 29800027.
    Citations: 1     Fields:    
  22. Beall RF, Darrow JJ, Kesselheim AS. A Method for Approximating Future Entry of Generic Drugs. Value Health. 2018 12; 21(12):1382-1389. PMID: 30502781.
    Citations:    Fields:    Translation:Humans
  23. Wang A, Kesselheim AS. Government Patent Use to Address the Rising Cost of Naloxone: 28 U.S.C. § 1498 and Evzio. J Law Med Ethics. 2018 06; 46(2):472-484. PMID: 30146993.
    Citations:    Fields:    
  24. Fralick M, Avorn J, Franklin JM, Bartsch E, Abdurrob A, Kesselheim AS. Application and Impact of Run-In Studies for the Evaluation of Statin Efficacy and Safety. J Gen Intern Med. 2018 06; 33(6):792-794. PMID: 29520746.
    Citations:    Fields:    
  25. Sinha MS, Kesselheim AS. The next forum for unraveling FDA off-label marketing rules: State and federal legislatures. PLoS Med. 2018 05; 15(5):e1002564. PMID: 29738523.
    Citations:    Fields:    
  26. Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS. Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines. Health Aff (Millwood). 2018 05; 37(5):724-731. PMID: 29733717.
    Citations:    Fields:    Translation:Humans
  27. Sarpatwari A, Beall RF, Abdurrob A, He M, Kesselheim AS. Evaluating The Impact Of The Orphan Drug Act's Seven-Year Market Exclusivity Period. Health Aff (Millwood). 2018 05; 37(5):732-737. PMID: 29733729.
    Citations:    Fields:    Translation:Humans
  28. Luo J, Kesselheim AS. Delayed Generic Market Saturation After Patent Expiration-A Billion-Dollar Problem. JAMA Intern Med. 2018 05 01; 178(5):721-722. PMID: 29801126.
    Citations:    Fields:    
  29. Sinha MS, Jain N, Hwang T, Kesselheim AS. Expansion of the Priority Review Voucher Program Under the 21st Century Cures Act: Implications for Innovation and Public Health. Am J Law Med. 2018 May; 44(2-3):329-341. PMID: 30106661.
    Citations:    Fields:    
  30. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 Jun 20; 36(18):1805-1812. PMID: 29688832.
    Citations: 1     Fields:    
  31. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation - Four Years of Experience. N Engl J Med. 2018 04 12; 378(15):1444-1453. PMID: 29641970.
    Citations: 1     Fields:    Translation:Humans
  32. Lee TT, Kesselheim AS. U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks. Ann Intern Med. 2018 May 15; 168(10):730-732. PMID: 29632953.
    Citations:    Fields:    
  33. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 03; 361:k1180. PMID: 29615391.
    Citations: 3     Fields:    Translation:Humans
  34. Jung E, Zettler PJ, Kesselheim AS. Prevalence of Publicly Available Expanded Access Policies. Clin Pharmacol Ther. 2018 Nov; 104(5):1016-1021. PMID: 29271014.
    Citations:    Fields:    
  35. Gupta R, Bollyky TJ, Cohen M, Ross JS, Kesselheim AS. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study. BMJ. 2018 03 19; 360:k831. PMID: 29555641.
    Citations:    Fields:    Translation:Humans
  36. Lee TT, Kesselheim AS, Kapczynski A. Legal Challenges to State Drug Pricing Laws. JAMA. 2018 03 06; 319(9):865-866. PMID: 29435585.
    Citations:    Fields:    
  37. Gagne JJ, Polinski JM, Jiang W, Dutcher SK, Xie J, Lii J, Fulchino LA, Kesselheim AS. Correction to: Outcomes Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence. Drugs. 2018 03; 78(4):523-524. PMID: 29520639.
    Citations:    Fields:    
  38. Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits? BMJ. 2018 02 22; 360:k587. PMID: 29472192.
    Citations: 1     Fields:    Translation:Humans
  39. Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS. Application and impact of run-in studies. J Gen Intern Med. 2018 May; 33(5):759-763. PMID: 29450684.
    Citations:    Fields:    
  40. Bothwell LE, Avorn J, Khan NF, Kesselheim AS. Adaptive design clinical trials: a review of the literature and ClinicalTrials.gov. BMJ Open. 2018 02 10; 8(2):e018320. PMID: 29440155.
    Citations: 2     Fields:    Translation:Humans
  41. Hey SP, Weijer C, Taljaard M, Kesselheim AS. Research ethics for emerging trial designs: does equipoise need to adapt? BMJ. 2018 01 25; 360:k226. PMID: 29371211.
    Citations:    Fields:    
  42. Sinha MS, Freifeld CC, Brownstein JS, Donneyong MM, Rausch P, Lappin BM, Zhou EH, Dal Pan GJ, Pawar AM, Hwang TJ, Avorn J, Kesselheim AS. Social Media Impact of the Food and Drug Administration's Drug Safety Communication Messaging About Zolpidem: Mixed-Methods Analysis. JMIR Public Health Surveill. 2018 Jan 05; 4(1):e1. PMID: 29305342.
    Citations:    
  43. Sinha MS, Kesselheim AS, Darrow JJ. Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship. Chest. 2018 01; 153(1):9-11. PMID: 29307432.
    Citations:    Fields:    
  44. Fralick M, Kesselheim AS, Avorn J, Schneeweiss S. Use of Health Care Databases to Support Supplemental Indications of Approved Medications. JAMA Intern Med. 2018 01 01; 178(1):55-63. PMID: 29159410.
    Citations: 3     Fields:    
  45. Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 12 28; 377(26):2597-2598. PMID: 29281576.
    Citations:    Fields:    
  46. Naci H, Kesselheim AS. Evidence Required for Drugs Granted Accelerated Approval-Reply. JAMA. 2017 12 26; 318(24):2493-2494. PMID: 29279923.
    Citations:    Fields:    Translation:Humans
  47. Darrow JJ, Fuse Brown EC, Kesselheim AS. The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health. N Engl J Med. 2018 Feb 01; 378(5):412-414. PMID: 29261363.
    Citations:    Fields:    Translation:PHPublic Health
  48. Sommers BD, Kesselheim AS. Massachusetts' Proposed Medicaid Reforms - Cheaper Drugs and Better Coverage? N Engl J Med. 2018 Jan 11; 378(2):109-111. PMID: 29236573.
    Citations:    Fields:    Translation:Humans
  49. Darrow JJ, Beall RF, Kesselheim AS. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 12 08; 35(12):1139-1141. PMID: 29220017.
    Citations:    Fields:    
  50. Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI. N Engl J Med. 2017 12 07; 377(23):2278-2286. PMID: 29211663.
    Citations:    Fields:    
  51. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016. JAMA. 2017 12 05; 318(21):2137-2138. PMID: 29209711.
    Citations: 1     Fields:    
  52. Sarpatwari A, Lee MP, Gagne JJ, Lu Z, Dutcher SK, Jiang W, Campbell EG, Kesselheim AS. Generic Versions of Narrow Therapeutic Index Drugs: A National Survey of Pharmaci