Kevin Outterson

Kevin Outterson

Professor of Law

Austin B. Fletcher Professor of Law
Executive Director of CARB-X

University of Reading, Rotary Scholar
BS, Northwestern University
JD, Northwestern University
LLM, University of Cambridge


Biography

Kevin Outterson, J.D., LL.M., is Professor of Law and Austin B. Fletcher Professor of Law at Boston University, where he co-directs the Health Law Program (ranked #5 in the country by U.S. News & World Report) and leads the Social Innovation on Drug Resistance program. He is also the founding Executive Director and Principal Investigator of Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a global non-profit partnership funded by the U.S., U.K., and German governments, Wellcome and the Bill & Melinda Gates Foundation. Its mission is to accelerate a diverse portfolio of innovative antibacterial products toward clinical development and regulatory approval. The CARB-X portfolio is the world’s most scientifically diverse, early development pipeline of new antibacterial therapeutics, diagnostics, and prevention. CARB-X is the only global partnership that includes prevention, diagnosis, and treatment of life-threatening bacterial infections. CARB-X has been awarded over $800 million in grants with Professor Outterson as Principal Investigator.

Professor Outterson’s primary areas of expertise are the law and economics of antimicrobial resistance, particularly push and pull incentives for antimicrobials. Professor Outterson has participated in many major reports and initiatives on antibacterial research and development. He served on the Advisory Panel for the Longitude Prize that offers an award for inventors creating affordable and rapid diagnostics to help clinicians identify effective antibiotics to treat drug-resistant bacteria. Professor Outterson received the 2015 Leadership Award by the Alliance for the Prudent Use of Antibiotics for his research and advocacy work.

Professor Outterson publishes in legal and peer-reviewed medical and health policy journals, including Yale Journal of Health Policy, Law and Ethics; Cardozo Law Review; University of Pittsburgh Law Review; Kansas Law Review; American Journal of Law & Medicine; New England Journal of Medicine; Health Affairs; The Lancet Infectious Diseases; Environmental Philosophy; The Medical Journal of Australia; Journal of Generic Medicines; Clinical Infectious Diseases; and Journal of Law, Medicine & Ethics.

Since 2000, Professor Outterson has published more than 90 peer-reviewed and legal articles. Examples of his recent publications related to antibiotic resistance include:

On behalf of The New England Journal of Medicine and other clients, Professor Outterson filed an amicus brief in the U.S. Supreme Court, supporting Vermont’s Prescription Confidentiality Law. His work was cited by Justice Breyer in Sorrell v. IMS Health Inc. A Boston University team led by Professors Outterson and Moncrieff filed four amicus briefs supporting the Affordable Care Act, which was heard by the Court in the spring of 2012.

He is past editor-in-chief of the Journal of Law, Medicine & Ethics; current faculty co-advisor to the American Journal of Law & Medicine; past chair of the Section on Law, Medicine & Health Care of the Association of American Law Schools; and the former President and member of the Board of the American Society of Law, Medicine & Ethics.

Before his academic career, Professor Outterson was a partner at two major U.S. law firms.

 

 

Publications

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  • Kevin Outterson, Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines 40 Health Affairs (2021)
    Scholarly Commons
  • Kevin Outterson, Laura Puzniak, Vikas Gupta, Kalvin C. Yu & Gang Ye, The Impact of Infections on Reimbursement in 92 US Hospitals, 2015-2018 49 American Journal of Infection Control (2021)
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  • Amila Nanayakkara, Helen Boucher, Vance Fowler, Amanda Jezek, Kevin Outterson & David Greenberg, Antibiotic resistance in the patient with cancer: Escalating challenges and paths forward 71 CA: A Cancer Journal for Clinicians (2021)
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  • Abigail Colson, Alec Morton, Christine Årdal, Kalipso Chalkidou, Sally Davies, Louis Garrison, Mark Jit, Ramanan Laxminarayan, Itamar Megiddo, Chantal Morel, Justice Nonvignon, Kevin Outterson, John Rex, Abdur Razzaque Sarker, Mark Sculpher, Beth Woods & Yue Xiao, Antimicrobial Resistance: Is Health Technology Assessment Part of the Solution or Part of the Problem? 24 Value in Health (2021)
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  • Kevin Outterson, Ebiowei S F Orubu, Muhammad H. Zaman, John Rex & Christine Ardal, Patient access in fourteen high-income countries to new antibacterials approved by the FDA, EMA, PMDA, or Health Canada, 2010-2020 Clinical Infectious Diseases (2021)
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  • Cecilia Kållberg, Jemma Hudson, Hege Salvesen Blix, Christine Årdal, Eili Klein, Morten Lindbæk, John-Arne Røttingen, Ramanan Laxminarayan & Kevin Outterson, The Effect of Generic Market Entry on Antibiotic Prescriptions in the United States 12 Nature Communications (2021)
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  • Helen Boucher, Thomas M. File, Vance Fowler, Amanda Jezek, John Rex & Kevin Outterson, Antibiotic Development Incentives That Reflect Societal Value of Antibiotics 72 Clinical Infectious Diseases (2021)
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  • John H. Rex & Kevin Outterson, Antibacterial R & D at a crossroads: We've pushed as hard as we can...now we need to start pulling! 73 Clinical Infectious Diseases (2021)
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  • Chantal Morel, Richard Alm, Christine Ardal, Alessandra Bandera, Giacomo Bruno, Elena Carrara, Giorgio Colombo, Marlieke de Kraker, Sabiha Essack, Isabel Frost, Bruno Gonzalez-Zorn, Herman Goossens, Luca Guardabassi, Stephan Harbarth, Peter Jørgensen, Souha Kanj, Tomislav Kostyanev, Ramanan Laxminarayan, Finola Leonard, Gabriel Levy Hara, Marc Mendelson, Malgorzata Mikulska, Nico Mutters, Kevin Outterson, Jesus Rodriguez Baňo, Evelina Tacconelli & Luigia Scudeller, A one health framework to estimate the cost of antimicrobial resistance 9 Antimicrobial Resistance & Infection Control (2020)
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  • Wes Kim, Kevin Krause, Zak Zimmerman & Kevin Outterson, Improving Data Sharing to Increase the Efficiency of Antibiotic 20 Nature Reviews Drug Discovery (2020)
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  • Kevin Outterson, Claas Kirchhelle, Paul Atkinson, Alex Broom, Komatra Chuengsatiansup, Jorge Pinto Ferreira, Nicolas Fortané, Isabel Frost, Christoph Gradmann, Stephen Hinchliffe, Steven J. Hoffman, Javier Lezaun, Susan Nayiga, Scott H. Podolsky, Stephanie Raymond, Adam P. Roberts, Andrew C. Singer, Anthony D. So, Luechai Sringernyuang, Elizabeth Tayler, Susan Rogers Van Katwyk & Clare I. R. Chandler, Setting the Standard: Multidisciplinary Hallmarks for Structural, Equitable and Tracked Antibiotic Policy 5 BMJ Global Health (2020)
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  • Kevin Outterson & John H. Rex, Evaluating for-profit public benefit corporations as an additional structure for antibiotic development and commercialization 220 Translational Research (2020)
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  • Ramanan Laxminarayan, Thomas Van Boeckel, Isabel Frost, Samuel Kariuki, Ejaz Ahmed Khan, Direk Limmathurotsakul, D G. Joakim Larsson, Gabriel Levy-Hara, Marc Mendelson, Kevin Outterson, Sharon J. Peacock & Yong-Guan Zhu, The Lancet Infectious Diseases Commission on antimicrobial resistance: 6 years later 20 The Lancet Infectious Diseases (2020)
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  • Kevin Outterson, Christine Årdal, Manica Balasegaram, Ramanan Laxminarayan, David McAdams, John Rex & Nithima Sumpradit, Antibiotic development & economic, regulatory and societal challenges 18 Nature Reviews Microbiology (2020)
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  • Kevin Outterson, John Rex, Holly Fernandez Lynch, I. Glen Cohen & Jonathan Darrow, Designing Development Programs for Non-Traditional Antibacterial Agents 10 Nature Communications (2019)
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  • Kevin Outterson, The global preclinical antibacterial pipeline 18 Nature Reviews Microbiology (2019)
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  • Kevin Outterson, Disproportionate Exposure to Antibiotics in Children at Risk for Invasive Pneumococcal Disease: Potential for Emerging Resistance and Opportunity for Antibiotic Stewardship 8 Journal of the Pediatric Infectious Diseases Society (2019)
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  • Cecilia Kållberg, Christine Årdal, Hege Salvesen Blix, Eili Klein, Elena Martinez, Morten Lindbæk, Kevin Outterson, John-Arne Røttingen & Ramanan Laxminarayan, Introduction and Geographic Availability of New Antibiotics Approved Between 1999 and 2014 13 PLoS ONE (2018)
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  • Kevin Outterson, Christine Ardal, Enrico Baraldi, Ursula Theuretzbacher, Francesco Ciabuschi, Jens Plahte & John-Arne Røttingen, Insights into Early Stage of Antibiotic Development in Small and Medium-Sized Enterprises: A Survey of Targets, Costs, and Durations 11 Journal of Pharmaceutical Policy and Practice (2018)
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  • Evelina Tacconelli, Elena Carrara, Alessia Savoldi, Stephan Harbarth, Marc Mendelson, Dominique L. Monnet, Celine Pulcini, Gunnar Kahlmeter, Jan Kluytmans, Yehuda Carmeli, Marc Ouellette, Kevin Outterson, Jean Patel, Marco Cavaleri, Edward M. Cox, Chris R. Houchens, M Lindsay Grayson, Paul Hansen, Nalini Singh, Ursula Theuretzbacher, Nicola Magrini & WHO Pathogens Priority List Working Group, Discovery, Research, and Development of New Antibiotics: The WHO Priority List of Antibiotic-Resistant Bacteria and Tuberculosis 18 The Lancet: Infectious Diseases (2018)
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  • Kevin Outterson, A Perspective on Incentives for Novel Inpatient Antibiotics: No One-Size-Fits-All 46 Journal of Law, Medicine & Ethics (2018)
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  • Nicole Huberfeld, Elizabeth Weeks Leonard & Kevin Outterson, The Law of American Health Care, 2nd ed. (2018)
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  • Nicole Huberfeld & Kevin Outterson, Teaching the Law of American Health Care 61 St. Louis University Law Journal (2017)
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  • Kevin Outterson, Unni Gopinathan, Charles Clift, Anthony So, Chantal Morel & John-Arne Røttingen, Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality 13 PLOS Medicine (2016)
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  • Kevin Outterson & Anthony McDonnell, Funding Antibiotic Innovation with Vouchers: Recommendations on How to Strengthen A Flawed Incentive Policy 35 Health Affairs (2016)
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  • Kevin Outterson & John Rex, Antibiotic Reimbursement in a Model Delinked from Sales: A Benchmark-based Worldwide Approach 16 The Lancet Infectious Diseases (2016)
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  • Kevin Outterson, Christine Ardal, Steven Hoffman, Abdul Ghafur, Mike Sharland, Nisha Ranganathan, Richard Smith, Anna Zorzet, Jennifer Cohn, Didier Pittet, Nils Daulaire, Chantal Morel, Zain Rizvi, Manica Balasegaram, Osman Dar, David Heymann, Alison Holmes, Luke Moore, Ramanan Laxminarayan, Marc Mendelson & John-Arne Røttingen, International Cooperation to Improve Access to and Sustain Effectiveness of Antimicrobials 387 The Lancet (2016)
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  • Nicole Huberfeld, Elizabeth Weeks Leonard & Kevin Outterson, The Law of American Health Care (2016)
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  • Kevin Outterson, Progress in the Fight Against Multidrug Resistant Bacteria?: A Review of FDA-Approved Antibiotics 2010-2015 165 Annals of Internal Medicine (2016)
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  • Kevin Outterson & Steven J. Hoffman, What Will It Take to Address the Global Threat of Antibiotic Resistance? 43 Journal of Law, Medicine and Ethics (2015)
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  • Kevin Outterson, Ella Jaczynska & Jorge Mestre-Ferrandiz, Business Model Options for Antibiotics: Learning from Other Industries (2015)
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  • Kevin Outterson, John H. Powers, Gregory W. Daniel & Mark B. McClellan, Repairing the Broken Market for Antibiotic Innovation 34 Health Affairs (2015)
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  • Kevin Outterson, Aylin Sertkaya, John T. Eyraud, Anna Birkenback, Calvin Franz, Nyssa Ackerley & Valerie Overton, Analytical Framework for Examining the Value of Antibacterial Products (2014)
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  • Kevin Outterson, The Drug Quality and Security Act - Mind the Gaps 370 New England Journal of Medicine (2014)
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  • Kevin Outterson, AHLA Health Law Curriculum Manual (2014)
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  • Kevin Outterson, Clinical Trial Transparency - Antidote to Increased Off-label Promotion? 371 New England Journal of Medicine (2014)
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  • Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio & Aaron S. Kesselheim, Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009 41 Journal of Law, Medicine and Ethics (2013)
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  • Kevin Outterson, Nicole Huberfeld & Elizabeth Weeks Leonard, Plunging into Endless Difficulties: Medicaid and Coercion in National Federation of Independent Business v. Sebelius 93 Boston University Law Review (2013)
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  • Kevin Outterson, All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act 30 APUA Clinical Newsletter (2012)
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  • Brief Amici Curiae of Prescription Policy Choices, Professors of Law, and Professors of Health Policy in Support of Petitioners on the Minimum Coverage Provision in Department of Health & Human Services v. State of Florida
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  • Kevin Outterson, Agents Without Principals: Regulating the Duty of Loyalty for Non Profit Corporations Through the Intermediate Sanctions Tax Regulations 5 Pepperdine Journal of Business Entrepreneurship & the Law (2012)
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  • Kevin Outterson & Shoshana Speiser, Deductions for Drug Ads? The Constitution Does Not Require Congress to Subsidize Direct-To-Consumer Prescription Drug Advertisements 52 Santa Clara Law Review (2012)
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  • Kevin Outterson, Regulating Compounding Pharmacies after NECC 367 New England Journal of Medicine (2012)
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  • Kevin Outterson, Thomas Pogge & Aidan Hollis, Combating Antibiotic Resistance Through the Health Impact Fund, in No. 11-30 Boston University School of Law, Law and Economics Research Paper (2011)
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  • Kevin Outterson, Evan Selinger & Kyle Whyte, Poverty Tourism, Justice and Policy No. 11-21 Boston University School of Law, Law and Economics Research Paper (2011)
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  • Kevin Outterson, Smoking and the First Amendment 365 New England Journal of Medicine (2011)
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  • Kevin Outterson, Improving Antibiotic Markets for Long Term Sustainability 11 Yale Journal of Health Policy, Law & Ethics (2011)
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  • Kevin Outterson, Higher First Amendment Hurdles for Public Health Regulation 365 New England Journal of Medicine (2011)
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  • Kevin Outterson, Towards New Business Models for R&D for Novel Antibiotics 14 Drug Resistance Updates (2011)
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  • Kevin Outterson, Poverty Tourism and the Problem of Consent 7 Journal of Global Ethics (2011)
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  • Kevin Outterson, Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals 29 Health Affairs (2010)
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  • Kevin Outterson, The Ethics of Poverty Tourism 7 Environmental Philosophy (2010)
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  • Kevin Outterson, The Legal Ecology of Resistance: The Role of Antibiotic Resistance in Pharmaceutical Innovation 31 Cardozo Law Review (2010)
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  • Kevin Outterson, Disease-Based Limitations on Compulsory Licenses Under Articles 31 and 31bis, in Research Handbook on the Protection of Intellectual Property Under WTO Rules (Carlos M. Correa,2010)
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  • Kevin Outterson, Will HPV Vaccines Prevent Cervical Cancers Among Poor Women of Color?: Global Health Policy at the Intersection of Human Rights and Intellectual Property Law 35 American Journal of Law & Medicine (2009)
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  • Kevin Outterson, The End of Reparations Talk? - Reparations in an Obama World 57 Kansas Law Review (2009)
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  • Kevin Outterson, Introduction: Pharmaceutical Innovation: Law & the Public's Health 37 Journal of Law, Medicine & Ethics (2009)
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  • Kevin Outterson, Import Safety Rules And Generic Drug Markets, in Import Safety: Regulatory Governance in the Global Economy (Cary Coglianese, Adam M. Finkel, David Zaring,2009)
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  • Kevin Outterson, Death from the Public Domain? 87 Texas Law Review (2009)
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  • Kevin Outterson, Pharmaceutical Innovation: Law & the Public's Health 37 Journal of Law, Medicine & Ethics (2009)
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  • Kevin Outterson, Foreword – Will HPV Vaccines Prevent Cervical Cancers Among Poor Women of Color?: Global Health Policy at the Intersection of Human Rights and Intellectual Property Law 35 American Journal of Law & Medicin (2009)
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  • Kevin Outterson & Donald W. Light, Global Pharmaceutical Markets, in A Companion to Bioethics (Helga Kuhse and Peter Singer,2009)
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  • Kevin Outterson, How Medicare Could Get Better Prices on Prescription Drugs 28 Health Affairs (2009)
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  • Kevin Outterson, Market-Based Licenses for HPV Vaccines in Developing Countries 27 Health Affairs (2008)
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  • Kevin Outterson, Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases? 34 American Journal of Law and Medicine (2008)
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  • Kevin Outterson, International Pharmaceutical Issues, in The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech (2007)
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  • Kevin Outterson, Will Longer Antimicrobial Patents Improve Global Public Health? 7 Lancet Infectious Diseases (2007)
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  • Kevin Outterson, Counterfeit Drugs: The Good, the Bad, and the Ugly 16 Albany Law Journal of Science & Technology (2006)
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  • Kevin Outterson, Fair Followers: Expanding Access to Generic Pharmaceuticals for Low- and Medium-Income Populations, in he Power of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing (Jillian Clare Cohen, Patricia Illingworth, Udo Schüklenk,2006)
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  • Kevin Outterson, Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries 32 American Journal of Law & Medicine (2006)
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  • Kevin Outterson, Tragedy & Remedy: Reparations for Disparities in Black Health 9 DePaul Journal of Health Care Law (2005)
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  • Kevin Outterson, The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Global Public Health 67 University of Pittsburgh Law Review (2005)
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  • Kevin Outterson, Agony in the Antipodes: The Generic Drug Provisions of the Australia-U.S. Free Trade Agreement 2 Journal of Generic Medicines (2005)
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  • Kevin Outterson, Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets 5 Yale Journal of Health Policy, Law & Ethics (2005)
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  • Kevin Outterson, Free Trade Against Free Riders? 9 Pharma Pricing & Reimbursement (2004)
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  • Kevin Outterson, Prohibition of the Slave Trade (1807), in Major Acts of Congress (2004)
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  • Kevin Outterson, Medicare Act (1965), in Major Acts of Congress (2004)
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  • Kevin Outterson, Slave Taxes, in Should America Pay?: Slavery and the Raging Debate over Reparations (Raymond A. Winbush,2003)
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  • Kevin Outterson, Health Care, Technology and Federalism 103 West Virginia Law Review (2001)
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  • Kevin Outterson, GP Corporatisation: Lessons Learned from the U.S. Experience 175 Medical Journal of Australia (2001)
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  • Kevin Outterson & Jennifer L. Butler, Disease Management: Legal Strategies for the Next Generation of Managed Care 31 Journal of Health Law (1998)
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  • Chi K. Cheung & Kevin Outterson, Revenue Procedure 91-12: The IRS Launches an Information-Gathering Offensive Against International Transportation Operations 91 Tax Notes International (1991)
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  • Kevin Outterson, Taxation Without Premeditation: An Economic Analysis of the Structure, Regulation and Strangulation of the Private Activity Bond Market 6 Boston University Journal of Tax Law (1988)
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In the Media

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  • USA Today November 15, 2022

    A Superbug Killed My Daughter at 25. Here’s How Congress Can Save Others.

    Kevin Outterson provides an insight.
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  • Superbugs Unplugged November 2, 2022

    King of Analogies: Kevin Outterson

    Kevin Outterson is interviewed on a podcast.
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  • Financial Times October 26, 2022

    Drugmakers Eye Government Money to Combat Antibiotic Resistance

    Kevin Outterson is quoted.
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  • Bloomberg September 19, 2022

    Should I Be Worried about Resistance to Antibiotics?

    Kevin Outterson is quoted.
    read more

  • Axios

    Superbugs Are a “Second Punch” after Pandemic

    Kevin Outterson is quoted.
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  • Association of Health Care Journalists September 12, 2022

    How Is The U.S. Preparing for the “Second Punch” of Antibiotic Resistance?

    Kevin Outterson is quoted.
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  • Bio News August 15, 2022

    AMR Could Be Worse Than The COVID-19 Pandemic, Experts Say

    Kevin Outterson is quoted.
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  • The Atlanta Journal-Constitution

    As Big Pharma Loses Interest in New Antibiotics, Infections Are Only Growing Stronger

    Kevin Outterson is quoted.
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  • Kaiser Health News July 15, 2022

    As Big Pharma Loses Interest in New Antibiotics, Infections Are Only Growing Stronger

    Kevin Outterson is quoted.
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  • Healthy Policy Watch July 12, 2022

    WHO Issues Urgent Call to Develop New Vaccines to Tackle Drug-Resistant Bacteria

    Kevin Outterson is quoted.
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  • Center for Global Development June 30, 2022

    A Grand Bargain for Antimicrobial Procurement: Leveraging Purchasing Systems to Address AMR

    Kevin Outterson speaks on a panel.
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  • Healthcare Weekly June 10, 2022

    HHS Promises up to $300 Million Over 10 Years to Fight Antibiotic-Resistant Bacteria

    Kevin Outterson is quoted.
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  • Bloomberg May 24, 2022

    A Better Way to Fund The Fight Against Superbugs

    Kevin Outterson is quoted.
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  • Homeland Preparedness News May 23, 2022

    HHS to Invest Up to $300M over Next 10 Years into CARB-X Efforts to Combat Antimicrobial Resistant Infections

    Kevin Outterson is quoted.
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  • Boston Business Journal May 20, 2022

    The Battle Against Bugs

    Kevin Outterson is quoted.
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Courses

Corporations: LAW JD 816

4 credits

Course about the legal structure and characteristics of business corporations. Topics include the promotion and formation of corporations; the distribution of power between management and shareholders; the limitations on management powers imposed by state law fiduciary duties and federal securities laws; shareholder derivative suits; capital structure and financing of corporations; and fundamental changes in corporate structure, such as mergers and sales of assets. The course serves as a prerequisite to advanced courses. PREREQUISITE: Business Fundamentals. GRADING NOTICE: The CR/NC/H option is not offered in Professor Tung's section.

FALL 2022: LAW JD 816 A1 , Sep 7th to Dec 7th 2022
Days Start End Credits Instructors Bldg Room
Mon,Wed 2:10 pm 4:10 pm 4 Scott Hirst LAW 103
FALL 2022: LAW JD 816 M1 , Sep 7th to Dec 7th 2022
Days Start End Credits Instructors Bldg Room
Mon,Wed 10:40 am 12:40 pm 4 Pierluigi Matera LAW 103
FALL 2022: LAW JD 816 T1 , Sep 6th to Dec 8th 2022
Days Start End Credits Instructors Bldg Room
Tue,Thu 2:10 pm 4:10 pm 4 Frederick Tung LAW 414
SPRG 2023: LAW JD 816 A1 , Jan 18th to Apr 26th 2023
Days Start End Credits Instructors Bldg Room
Mon,Wed 2:10 pm 4:10 pm 4 Kevin Outterson LAW 414