Jonathan Darrow
Jonathan Darrow, SJD, LLM, JD, MBA, BS
Assistant Professor of Medicine, Harvard Medical School
Faculty Member of the Center for Bioethics
Member, HMS Center for Bioethics

Jonathan J. Darrow, SJD, LLM, JD, MBA, BS, is an Assistant Professor at Harvard Medical School, where he focuses on the intersection of law, innovation, and pharmaceuticals. He received his research doctorate (SJD) in pharmaceutical policy from Harvard University, where he completed an LL.M. program in intellectual property (waived), as well as degrees in genetics (BS), law (JD), and business (MBA) from Cornell University, Duke University, and Boston College. He has served as a senior law clerk at the U.S. Court of Appeals for the Federal Circuit, worked in private law practice at Cooley LLP and Wiley Rein LLP, taught on the faculties of four universities and for the World Intellectual Property Organization, authored several law textbooks, supported the intellectual property divisions of WHO and WTO, and lectured widely on issues of innovation, intellectual property, and FDA regulation. His areas of bioethical interest include patient autonomy as part of pharmaceutical selection and use, disclosure of drug efficacy information in advertisements, physician and regulator conflicts of interest, and trade-offs that occur when insurance coverage is mandated for high-cost but low-value products.

Publications View
Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines.
Authors: Authors: Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ.
J Clin Oncol
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Precision Medicines Have Faster Approvals Based On Fewer And Smaller Trials Than Other Medicines.
Authors: Authors: Pregelj L, Hwang TJ, Hine DC, Siegel EB, Barnard RT, Darrow JJ, Kesselheim AS.
Health Aff (Millwood)
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The FDA Breakthrough-Drug Designation - Four Years of Experience.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
N Engl J Med
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The Regulatory Accountability Act of 2017 - Implications for FDA Regulation and Public Health.
Authors: Authors: Darrow JJ, Fuse Brown EC, Kesselheim AS.
N Engl J Med
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Pharmaceutical Advertising in Medical Journals: Revisiting a Long-Standing Relationship.
Authors: Authors: Sinha MS, Kesselheim AS, Darrow JJ.
Chest
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Will inter partes review speed US generic drug entry?
Authors: Authors: Darrow JJ, Beall RF, Kesselheim AS.
Nat Biotechnol
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Speed, Safety, and Industry Funding - From PDUFA I to PDUFA VI.
Authors: Authors: Darrow JJ, Avorn J, Kesselheim AS.
N Engl J Med
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The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
Authors: Authors: Hwang TJ, Darrow JJ, Kesselheim AS.
JAMA
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A New Approach to Treat Childhood Leukemia: Novartis' CAR-T Therapy.
Authors: Authors: Tessema FA, Darrow JJ.
J Law Med Ethics
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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.
Authors: Authors: Kesselheim AS, Wang B, Franklin JM, Darrow JJ.
BMJ
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