Kevin Outterson

Professor of Law

N. Neal Pike Scholar in Health and Disability Law

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

Areas of Interest
Health Law, Intellectual Property
Contact
  • Office Room 1402K
  • Phone 617-353-3103
Biography

Professor Kevin Outterson teaches health law and corporate law at Boston University, where he co-directs the Health Law Program, currently ranked #2 in the country by US News and World Report. He serves as the editor-in-chief of the Journal of Law, Medicine & Ethics; faculty co-advisor to the American Journal of Law & Medicine; past chair of the Section on Law, Medicine & Health Care of the AALS; and a member of the Board of the American Society of Law, Medicine & Ethics. Professor Outterson was recently named to the Advisory Panel for the Longitude Prize, which awards £10 million to address antibiotic resistance. Before teaching, Outterson was a partner at two major US law firms.

His research focuses on the organization and finance of the health sector. Areas of specialization include global pharmaceutical markets, particularly antibiotics and other antimicrobials that can degrade in usefulness over time through resistance. He received a grant from the European Union’s Innovative Medicines Initiative to study business models and incentives for antibiotic development, and he leads an interdisciplinary project on the legal ecology of antimicrobial resistance, funded in part by the Robert Wood Johnson Foundation program on public health law. He is an associate fellow at the Royal Institute of International Affairs at Chatham House, London, where he works on global solutions to antibiotic resistance, and an appointed member of the Antimicrobial Resistance Working Group at the Centers for Disease Control.

Professor Outterson has testified before President Obama’s Advisory Council on Combating Antibiotic Resistance, where he presented the results of a two-year study sponsored by the European Union on designing economic incentives for antibiotic development.

  • Click here for a BU Research interview about Professor Outterson’s work on antibiotic resistance.

Another significant body of work critiques access and equity issues created by global patent and drug regulation laws. Key texts in this debate include the WTO TRIPS Agreement and related trade agreements.

Professor Outterson publishes in both legal journals (Yale Journal of Health Policy, Law & Ethics; Cardozo Law Review; University of Pittsburgh Law Review; Kansas Law Review; American Journal of Law & Medicine) and peer-reviewed medical and health policy journals (New England Journal of Medicine; Health Affairs; Lancet Infectious Diseases; Environmental Philosophy; Medical Journal of Australia; Journal of Generic Medicines; Clinical Infectious Diseases; Journal of Law, Medicine & Ethics). He blogs on health policy issues at The Incidental Economist, one of the leading health economics blogs in the US.

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

His academic papers can be found on his SSRN page.

 

Publications
  1. Kevin Outterson et al., "International Cooperation to Improve Access to and Sustain Effectiveness of Antimicrobials," 387 Lancet 296 (Jan 16-22, 2016).
  2. Kevin Outterson, E. Jaczynska & J. Mestre-Ferrandiz, Business Model Options for Antibiotics: Learning from Other Industries, Chatham House Centre for Global Health Security & The Big Innovation Centre, (Feb 2015).
  3. Kevin Outterson et al., "An International Legal Framework to Address Antimicrobial Resistance," 93 Bulletin of the WHO 66 (Feb 2015).
  4. Kevin Outterson, John H. Powers III, Gregory W. Daniel & Mark B. McClellan, "Repairing the Broken Market for Antibiotic Innovation," 34 Health Affairs 277 (Feb 2015).
    SSRN
  5. Kevin Outterson, C. Clift, U. Gopinathan, C. Morel, J. A. Rottingen & A. D. So, Report from the Chatham House Working Group on New Antibiotic Business Models, Chatham House Centre for Global Health Security, (Mar 2015).
  6. Kevin Outterson & Steven J. Hoffman, "What Will It Take to Address the Global Threat of Antibiotic Resistance?" 43 Journal of Law, Medicine and Ethics 363 (2015).
    SSRN
  7. Kevin Outterson, AHLA Health Law Curriculum Manual, Kevin Outterson, ed., American Health Lawyers Association (2014).
    Publisher
  8. Kevin Outterson et al., Analytical Framework for Examining the Value of Antibacterial Products, US Department of Health & Human Services / ASPE, (Apr 15, 2014).
    SSRN | Publisher
  9. Kevin Outterson, "Clinical Trial Transparency - Antidote to Increased Off-label Promotion?" 371 New England Journal of Medicine 1 (2014).
  10. Kevin Outterson, "The Drug Quality and Security Act - Mind the Gaps," 370 New England Journal of Medicine 97 (2014).
  11. Kevin Outterson, John H. Powers III, Enrique Seoane-Vazquez, 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 688 (2013).
    SSRN
  12. Kevin Outterson, T. Pogge & A. Hollis, "Combatting Antibiotic Resistance Through the Health Impact Fund," in The Globalization of Health Care: Legal and Ethical Issues 318, Glenn I. Cohen, ed., Oxford University Press (2013).
  13. Kevin Outterson, N. Huberfield & E. W. Leonard, "Plunging into Endless Difficulties: Medicaid and Coercion in National Federation of Independent Business v. Sebelius," 93 Boston University Law Review 1 (2013).
    SSRN | HeinOnline (BU) | HeinOnline
  14. Kevin Outterson & C. B. Eisenberg, "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 243 (2012).
    BU
  15. Kevin Outterson, "All Pain, No GAIN: Need for Prudent Antimicrobial Use Provisions to Complement the GAIN Act," 30:1 APUA Clinical Newsletter 13 (2012).
    Publisher | BU
  16. Kevin Outterson, Amici Curiae Brief on Behalf of the Department of Health and Human Services, DHHS v. Florida, U.S. Supreme Court, No. 11-398 (Jan 13, 2012). [ACA litigation, minimum coverage provision]
    SSRN
  17. Kevin Outterson, Amici Curiae Brief on Behalf of the Department of Health and Human Services, Florida v. DHHS, U.S. Supreme Court, (Feb 17, 2012). [ACA litigation, Medicaid expansion]
    BU
  18. Kevin Outterson, T. Pogge & A. Hollis, "Combatting Antibiotic Resistance Through the Health Impact Fund," in The Globalization of Health Care: Legal and Ethical Issues , Glenn I. Cohen, ed., Oxford University Press (2012). BU
  19. Kevin Outterson & S. Speiser, "Deductions for Drug Ads? The Constitution Does Not Require Congress to Subsidize Direct-To-Consumer Prescription Drug Advertisements," 52 Santa Clara Law Review 453 (2012).
    BU
  20. Kevin Outterson, Evan Selinger & Kyle Whyte, "Poverty Tourism, Justice, and Policy: Can Ethical Ideals Form the Basis of New Regulations?" 14 Public Integrity 39 (2011-12).
    BU
  21. Kevin Outterson, "Regulating Compounding Pharmacies after NECC," 367 New England Journal of Medicine 1969 (Nov 22, 2012).
  22. Kevin Outterson, Blog Posts Incidental Economist (2011).
  23. Kevin Outterson & Austin Frakt, "After the Deluge: Health Reform Without an Individual Mandate," Kaiser Health News (Feb 24, 2011).
    Publisher
  24. Kevin Outterson, Amici Curiae Brief on Behalf of the New England Journal of Medicine, the Massachusetts Medical Society, the National Physicians Alliance, and the American Medical Students Association in Sorrell v. IMS Health Inc., U.S. Supreme Court, (Mar 1, 2011). [defending Vermont’s data mining law]
    SSRN
  25. Kevin Outterson & Olga Yevtukhova, "Germ Shed Management in the United States," in Antibiotic Policies: Controlling Hospital Acquired Infection 163, Ian M. Gould & Jos van der Meer, eds., Springer (2011). SSRN
  26. Kevin Outterson, "Higher First Amendment Hurdles for Public Health Regulation," 365 New England Journal of Medicine e13 (2011).
  27. Kevin Outterson & Aaron S. Kesselheim, "Improving Antibiotic Markets for Long Term Sustainability," 11 Yale Journal of Health Policy, Law & Ethics 101 (2011).
    SSRN
  28. Kevin Outterson, Kyle Whyte & Evan Selinger, "Poverty Tourism and the Problem of Consent," 7 Journal of Global Ethics 337 (2011).
    SSRN
  29. Kevin Outterson, "Smoking and the First Amendment," 365 New England Journal of Medicine 2351 (2011).
  30. Kevin Outterson, A. D. So et al., "Towards New Business Models for R&D for Novel Antibiotics," 14 Drug Resistance Updates 88 (2011).
  31. 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 673, Carlos Correa, ed., Edward Elgar Pub (2010). SSRN
  32. Kevin Outterson & Evan Selinger, "The Ethics of Poverty Tourism," 7:2 Environmental Philosophy 93 (2010).
    SSRN
  33. Kevin Outterson & Aaron S. Kesselheim, "Fighting Antibiotic Resistance: Marrying New Financial Incentives To Meeting Public Health Goals," 29 Health Affairs 1689 (2010).
    SSRN
  34. Kevin Outterson, "The Legal Ecology of Resistance: The Role of Antibiotic Resistance in Pharmaceutical Innovation," 31 Cardozo Law Review 613 (2010).
    SSRN
  35. Kevin Outterson, John H. Powers III, Ian M. Gould & Aaron S. Kesselheim, "Questions About the 10 x '20 Initiative," 51 Clinical Infectious Diseases 751 (2010).
  36. Kevin Outterson & Aaron S. Kesselheim, "Superbugs Call for Super Changes in Drug Sale Rules," Boston Globe A11 (Nov. 15, 2010).
  37. Kevin Outterson, Pharmaceutical Innovation: Law & the Public's Health v.37:2 Journal of Law, Medicine & Ethics, editor (2009).
  38. Access to HPV Vaccines: Human Rights and Global Health, 35:2 & 3, Kevin Outterson & Frances Miller, eds., American Journal of Law and Medicine (2009).
  39. Kevin Outterson, Amici Curiae Brief on Behalf of the New England Journal of Medicine, the Vermont Medical Society, the Massachusetts Medical Society, the New Hampshire Medical Society, the National Physicians Alliance, and the American Medical Students Association, in IMS, 2nd Circuit, (2009).
    SSRN
  40. Kevin Outterson, Comments on the Physician Payment Sunshine Act of 2009, Submission to the U.S. Senate Committee on Aging, (Jan. 26, 2009).
  41. Kevin Outterson, "Death from the Public Domain?" 87 Texas Law Review See Also 45 (2009).
    SSRN | Publisher
  42. Kevin Outterson, "Drug & Device Provisions in House Bill 3962," 15 PhRMA Pricing and Reimbursement 1 (Dec. 2009).
  43. Kevin Outterson, "The End of Reparations Talk? - Reparations in an Obama World," 57 Kansas Law Review 935 (2009).
    SSRN
  44. 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 & Medicine 247 (2009).
    Westlaw | Lexis Advance | HeinOnline (BU) | HeinOnline
  45. Kevin Outterson & Paige Goodwin, "From Comparative Effectiveness to Cost Effectiveness?" 14 PhRMA Pricing and Reimbursement 126 (May 2009).
  46. Kevin Outterson & Donald Light, "Global Pharmaceutical Markets," in A Companion to Bioethics 417, 2d ed., H. Kuhse & P. Singer, eds., Blackwell (2009). SSRN
  47. Kevin Outterson & Aaron S. Kesselheim, "How Medicare Could Get Better Prices on Prescription Drugs," 28 Health Affairs W832 (2009).
    Publisher
  48. Kevin Outterson, "Import Safety Rules And Generic Drug Markets," in Import Safety: Regulatory Governance in the Global Economy 110, C. Coglianese, A. Finkel & D. Zaring, eds., University of Pennsylvania Press (2009). SSRN
  49. Kevin Outterson, "Introduction: Pharmaceutical Innovation: Law & the Public's Health," in Symposium Pharmaceutical Innovation: Law & the Public's Health, 37 Journal of Law, Medicine & Ethics 173 (2009).
    Lexis Advance
  50. Kevin Outterson, Priority Watch List Treatment for Thailand and Brazil Under Section 182 of the Trade Act of 1974, submission to the United States Trade Representative, Docket USTR-2009-0001 (Feb. 17, 2009).
  51. Kevin Outterson, "Antibiotic Resistance and Antibiotic Development - Author's Reply," 8 Lancet Infectious Diseases 212 (2008).
    Publisher
  52. Kevin Outterson & Aaron S. Kesselheim, "Market-Based Licenses for HPV Vaccines in Developing Countries," 27 Health Affairs 130 (2008).
    Publisher
  53. Kevin Outterson, "Should Access to Medicines and TRIPS Flexibilities Be Limited to Specific Diseases?" 34 American Journal of Law and Medicine 279 (2008).
    SSRN
  54. Kevin Outterson & Paige Goodwin, "FDA Act Creates New Incentives for Tropical Diseases, Orphan Antibiotics," 12 PhRMA Pricing and Reimbursement 350 (2007).
  55. Kevin Outterson, "International Pharmaceutical Issues," in The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech 441, American Health Lawyers Association (2007).
  56. Kevin Outterson, J. B. Samora & K. Keller-Cuda, "Will Longer Antimicrobial Patents Improve Global Public Health?" 7 Lancet Infectious Diseases 559 (2007).
    SSRN
  57. Kevin Outterson, Access to Global Disease Innovation, submission to WHO Intergovernmental Working Group, (2006).
    SSRN
  58. Kevin Outterson & Ryan Smith, "Counterfeit Drugs: The Good, the Bad, and the Ugly," 16 Albany Law Journal of Science & Technology 525 (2006).
    SSRN
  59. Kevin Outterson, "Fair Followers: Expanding Access to Generic Pharmaceuticals for Low- and Medium-Income Populations," in The Power of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing 164, Jillian Clare Cohen, Patricia Illingworth & Udo Schuklenk, eds., University of Michigan/Pluto Press (2006). Portuguese translation: 'Fair Followers': Expandindo o Acesso a Medicamentos Genericos para a Populacao de Baixa e Media Renda (2007).SSRN
  60. Kevin Outterson & Ilona Volker, "New Legislative Trends Threaten the Way Health Information Companies Operate," 11 PhRMA Pricing and Reimbursement 324 (2006).
  61. Kevin Outterson, "Patent Buy-Outs for Global Disease Innovations for Low- and Middle-Income Countries," 32 American Journal of Law & Medicine 159 (2006).
    SSRN
  62. Kevin Outterson, "Agony in the Antipodes: The Generic Drug Provisions in the Australia - US Free Trade Agreement," 2 Journal of Generic Medicines 316 (2005).
    SSRN
  63. Kevin Outterson, "Pharmaceutical Arbitrage: Balancing Access and Innovation in International Prescription Drug Markets," 5 Yale Journal of Health Policy, Law & Ethics 193 (2005).
    SSRN
  64. Kevin Outterson, "Tragedy & Remedy: Reparations for Disparities in Black Health," 9 DePaul Journal of Health Care Law 735 (2005).
    SSRN
  65. Kevin Outterson, "The Transparency Revolution in PhRMA Pricing," 10 PhRMA Pricing and Reimbursement 4 (2005).
  66. Kevin Outterson, "The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Global Public Health," 67 University of Pittsburgh Law Review 67 (2005).
    SSRN
  67. Kevin Outterson, "Free Trade Against Free Riders?" 9 PhRMA Pricing and Reimbursement 254 (2004).
    SSRN
  68. Kevin Outterson, "Free Trade in Pharmaceuticals," 181 Medical Journal of Australia 260 (2004).
    Publisher
  69. Kevin Outterson, "Medicare Act (1965)," in Major Acts of Congress, Brian K. Landsberg, ed., MacMillan, 264 (2004).
  70. Kevin Outterson, "More Questions Than Answers: A Quick Response to the USTR Press Release on the AUSFTA," www.citizenstrade.org (2004).
    Publisher
  71. Kevin Outterson, "Pharma Under George III," 9 PhRMA Pricing and Reimbursement 352 (2004).
  72. Kevin Outterson, "Prohibition of the Slave Trade (1807)," in Major Acts of Congress, Brian K. Landsberg, ed., MacMillan, 138 (2004).
  73. Kevin Outterson, "Rapid Response to Editorial," British Medical Journal (Jun 23, 2004). Commenting on: P. Drahos & D. Henry, "The Free Trade Agreement Between Australia and the United States," 328 British Medical Journal 1271 (May 2004).
    Publisher
  74. Kevin Outterson, Amicus Brief on Behalf of Respondents in Gratz v. Bollinger and Grutter v. Bollinger on behalf of the National Coalition of Blacks for Reparations in America and the National Conference of Black Lawyers, U.S. Supreme Court, (Feb. 14, 2003). [the Michigan affirmative action cases]
  75. Kevin Outterson, "Slave Taxes," in Should America Pay?: Slavery and the Raging Debate over Reparations 135, Raymond Winbush, ed., Harper Collins (2003). Reprinted in Studies in the History of Tax Law 263, John Tiley, ed., Hart Publishing (2004).
  76. Kevin Outterson, "GP Corporatisation: Lessons Learned from the U.S. Experience," 175:8 Medical Journal of Australia 426 (2001).
  77. Kevin Outterson, "Health Care, Technology and Federalism," 103 West Virginia Law Review 503 (2000-01).
    Westlaw | Lexis Advance | HeinOnline (BU) | HeinOnline
  78. Kevin Outterson & Jennifer L. Butler, "Disease Management: Legal Strategies for the Next Generation of Managed Care," 31 Journal of Health Law 291 (1998). Updated and republished as Disease Management and Gainsharing: The Next Generation of Managed Care, with Claire F. Miley & Jennifer L. Butler, 2d ed., AHLA Monograph (1999).
  79. Kevin Outterson & Cheung, "Revenue Procedure 91-12: The IRS Launches an Information-Gathering Offensive Against International Transportation Operations," 91 Tax Notes International 71 (1991).
  80. 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 1 (1988).
    HeinOnline (BU) | HeinOnline
Courses

0 credits

Introduction to Business Fundamentals is an online, self-paced, asynchronous program forming a required part of the JD curriculum. The curriculum consists of modules covering business basics, corporate finance and financial accounting, including the following subjects: capital markets; the basics of financial reporting; balance sheets; income statements and cash flow; business forms and organizations; financing organizations; discounting; and calculating risk, return and valuation. Assessment is based on multiple choice exams. Students may opt-out of the course if they score an 84% or better on the pre-course exam. A score of 70% or better on the post-course exam, following successful completion of the course, is necessary to meet the requirement. GRADING NOTICE: This course awards no credits and is graded P/F. It is a graduation requirement for JD students who will be graduating with the Class of 2017 or later. Students may enroll in the program for the fall, spring or summer semesters, but should complete the course by the conclusion of the fall semester of the 3L year.

FALL 2015: LAW JD 605 OL , Aug 31st to Dec 4th 2015
Days Start End Credits Instructors Bldg
ARR TBD TBD 0 Kevin Outterson
SPRG 2016: LAW JD 605 OL , Jan 11th to Apr 20th 2016
Days Start End Credits Instructors Bldg
ARR TBD TBD 0 Kevin Outterson
FALL 2016: LAW JD 605 OL , Sep 6th to Jan 13th 2016
Days Start End Credits Instructors Bldg
ARR TBD TBD 0 David I. Walker
SPRG 2017: LAW JD 605 OL , Jan 17th to Apr 26th 2017
Days Start End Credits Instructors Bldg
ARR TBD TBD 0 David I. Walker

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. GRADING NOTICE: The CR/NC/H option is not offered in Professor Walker or Professor Tung's sections.

FALL 2015: LAW JD 816 A1 , Aug 31st to Dec 2nd 2015
Days Start End Credits Instructors Bldg
Mon,Wed 8:30 am 10:30 am 4 Kevin Outterson LAW
FALL 2015: LAW JD 816 M1 , Sep 1st to Dec 3rd 2015
Days Start End Credits Instructors Bldg
Tue,Thu 8:30 am 10:30 am 4 Stephen G. Marks LAW
SPRG 2016: LAW JD 816 M1 , Jan 12th to Apr 19th 2016
Days Start End Credits Instructors Bldg
Tue,Thu 10:40 am 12:40 pm 4 Stephen G. Marks LAW
FALL 2016: LAW JD 816 A1 , Sep 6th to Dec 8th 2016
Days Start End Credits Instructors Bldg
Tue,Thu 2:10 pm 4:10 pm 4 Stephen G. Marks
FALL 2016: LAW JD 816 W1 , Sep 7th to Dec 7th 2016
Days Start End Credits Instructors Bldg
Mon,Wed 8:30 am 10:30 am 4 David I. Walker
SPRG 2017: LAW JD 816 M1 , Jan 18th to Apr 26th 2017
Days Start End Credits Instructors Bldg
Mon,Wed 10:40 am 12:40 pm 4 Stephen G. Marks

4 credits

This class introduces the significant laws regulating the US health care sector, particularly the finance, organization and delivery of health care through our blended system of public & private insurance. Health law offers a privileged role to experts, particularly physicians, but simultaneously recognizes that health professionals and institutions are prone to decision making that generates enormous agency costs. These laws are generally responsible for the growth of health law as a recognized specialization in legal practice, while health care represents nearly one fifth of US economic activity. We also discuss health policy in the context of cost, quality and access, with some international comparisons. Some of the work in the class will be assigned in teams with class presentations. A final examination will be offered.

FALL 2016: LAW JD 856 A1 , Sep 7th to Dec 7th 2016
Days Start End Credits Instructors Bldg
Mon,Wed 8:30 am 10:30 am 4 Kevin Outterson
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