Kevin Outterson | Profiles RNS

Kevin Outterson, JD, LLM

Professor of Law and N. Neal Pike Scholar

Boston University School of Law

Dept of Health and Disability Law

LLM, University of Cambridge
JD, Northwestern University School of Law

Websites

	School of Law Faculty
	Public Relations - BU Experts

ORCID : 0000-0003-2513-3216

Research interests in pharmaceutical innovation, including the law & economics of antimicrobial resistance.

Associate Professor of Health Law, Ethics & Human Rights
Boston University School of Public Health
Health Law, Policy & Management
Center for Health Law, Ethics & Human Rights

Executive Director of CARB-X
Boston University School of Law
Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X)

BU Research

CARB-X Global Antibacterial Accelerator
10/06/2021 - 10/05/2024 (Multi-PI)
PI: Kevin Outterson, JD, LLM
Wellcome Trust

Accelerating the Development ofinnovative Preventive Approaches to Combat AMR
05/18/2018 - 05/31/2023 (PI)
Bill and Melinda Gates Foundation

VALUE-Dx
04/01/2019 - 03/31/2023 (Multi-PI)
PI: Kevin Outterson, JD, LLM
University of Antwerp European Commission

Accelerating the Development of innovative Preventive Approaches to Combat AMR
01/01/2019 - 12/31/2022 (PI)
The German Federal Ministry of Education and Research

RESTRICTED: Accelerating the Development of Innovative Preventive Approaches to Combat AMR
01/01/2019 - 12/31/2022 (PI)
The German Federal Ministry of Education and Research

WT CARB-X PD/Acc Costs Cost-Share
04/01/2017 - 12/31/2022 (PI)
Wellcome Trust

WT CARB-X Core Mgmt/Other Program Support
01/01/2019 - 07/31/2022 (PI)
Wellcome Trust

WT CARB-X Non Awardee Costs
04/01/2017 - 07/31/2022 (PI)
Wellcome Trust

CARB-X
08/01/2016 - 07/31/2022 (PI)
HHS/Assistant Secretary for Preparedness and Response
6 IDSEP160030-05-07

CARB-X/ UK GAMRIF
05/18/2018 - 03/31/2022 (PI)
Department of Health and Social Care

Title

Yr	Title	Project-Sub Proj	Pubs

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.

iCite Analysis Copy PMIDs To Clipboard

Outterson K, Orubu ESF, Rex J, Årdal C, Zaman MH. Patient Access in 14 High-Income Countries to New Antibacterials Approved by the US Food and Drug Administration, European Medicines Agency, Japanese Pharmaceuticals and Medical Devices Agency, or Health Canada, 2010-2020. Clin Infect Dis. 2022 Apr 09; 74(7):1183-1190. PMID: 34251436; PMCID: PMC8994582; DOI: 10.1093/cid/ciab612;

Rex JH, Outterson K. Antibacterial R&D at a Crossroads: We've Pushed as Hard as We Can … Now We Need to Start Pulling! Clin Infect Dis. 2021 12 06; 73(11):e4451-e4453. PMID: 32584949

Outterson K. Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines. Health Aff (Millwood). 2021 11; 40(11):1758-1765. PMID: 34724432

Nanayakkara AK, Boucher HW, Fowler VG, Jezek A, Outterson K, Greenberg DE. Antibiotic resistance in the patient with cancer: Escalating challenges and paths forward. CA Cancer J Clin. 2021 11; 71(6):488-504. PMID: 34546590

Colson AR, Morton A, Årdal C, Chalkidou K, Davies SC, Garrison LP, Jit M, Laxminarayan R, Megiddo I, Morel C, Nonvignon J, Outterson K, Rex JH, Sarker AR, Sculpher M, Woods B, Xiao Y. Antimicrobial Resistance: Is Health Technology Assessment Part of the Solution or Part of the Problem? Value Health. 2021 12; 24(12):1828-1834. PMID: 34838281

Kållberg C, Hudson J, Salvesen Blix H, Årdal C, Klein E, Lindbæk M, Outterson K, Røttingen JA, Laxminarayan R. The effect of generic market entry on antibiotic prescriptions in the United States. Nat Commun. 2021 05 18; 12(1):2937. PMID: 34006862; PMCID: PMC8131704; DOI: 10.1038/s41467-021-23049-4;

Boucher HW, File TM, Fowler VG, Jezek A, Rex JH, Outterson K. Antibiotic Development Incentives That Reflect Societal Value of Antibiotics. Clin Infect Dis. 2021 05 04; 72(9):e420-e421. PMID: 31999818

Puzniak L, Gupta V, Yu KC, Ye G, Outterson K. The impact of infections on reimbursement in 92 US hospitals, 2015-2018. Am J Infect Control. 2021 10; 49(10):1275-1280. PMID: 33891989

Kim W, Krause K, Zimmerman Z, Outterson K. Improving data sharing to increase the efficiency of antibiotic R&D. Nat Rev Drug Discov. 2021 01; 20(1):1-2. PMID: 33097914

Minssen T, Outterson K, Rogers Van Katwyk S, Batista PHD, Chandler CIR, Ciabuschi F, Harbarth S, Kesselheim AS, Laxminarayan R, Liddell K, Osterholm MT, Price L, Hoffman SJ. Social, cultural and economic aspects of antimicrobial resistance. Bull World Health Organ. 2020 Dec 01; 98(12):823-823A. PMID: 33293739; PMCID: PMC7716096; DOI: 10.2471/BLT.20.275875;

Showing 10 of 85 results. Show More

Morel CM, Alm RA, Årdal C, Bandera A, Bruno GM, Carrara E, Colombo GL, de Kraker MEA, Essack S, Frost I, Gonzalez-Zorn B, Goossens H, Guardabassi L, Harbarth S, Jørgensen PS, Kanj SS, Kostyanev T, Laxminarayan R, Leonard F, Hara GL, Mendelson M, Mikulska M, Mutters NT, Outterson K, Bano JR, Tacconelli E, Scudeller L. A one health framework to estimate the cost of antimicrobial resistance. Antimicrob Resist Infect Control. 2020 11 26; 9(1):187. PMID: 33243302; PMCID: PMC7689633; DOI: 10.1186/s13756-020-00822-6;

Kirchhelle C, Atkinson P, Broom A, Chuengsatiansup K, Ferreira JP, Fortané N, Frost I, Gradmann C, Hinchliffe S, Hoffman SJ, Lezaun J, Nayiga S, Outterson K, Podolsky SH, Raymond S, Roberts AP, Singer AC, So AD, Sringernyuang L, Tayler E, Rogers Van Katwyk S, Chandler CIR. Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy. BMJ Glob Health. 2020 09; 5(9). PMID: 32967980; PMCID: PMC7513567; DOI: 10.1136/bmjgh-2020-003091;

Outterson K, Rex JH. Evaluating for-profit public benefit corporations as an additional structure for antibiotic development and commercialization. Transl Res. 2020 06; 220:182-190. PMID: 32165059

Laxminarayan R, Van Boeckel T, Frost I, Kariuki S, Khan EA, Limmathurotsakul D, Larsson DGJ, Levy-Hara G, Mendelson M, Outterson K, Peacock SJ, Zhu YG. The Lancet Infectious Diseases Commission on antimicrobial resistance: 6 years later. Lancet Infect Dis. 2020 04; 20(4):e51-e60. PMID: 32059790

Årdal C, Balasegaram M, Laxminarayan R, McAdams D, Outterson K, Rex JH, Sumpradit N. Antibiotic development - economic, regulatory and societal challenges. Nat Rev Microbiol. 2020 05; 18(5):267-274. PMID: 31745330

Theuretzbacher U, Outterson K, Engel A, Karlén A. The global preclinical antibacterial pipeline. Nat Rev Microbiol. 2020 05; 18(5):275-285. PMID: 31745331; PMCID: PMC7223541; DOI: 10.1038/s41579-019-0288-0;

Van Katwyk SR, Balasegaram M, Boriello P, Farrar J, Giubilini A, Harrison M, Kieny MP, Kirchhelle C, Liu J, Outterson K, Pate MA, Poirier M, Røttingen JA, Savulescu J, Sugden R, Thamlikitkul V, Weldon I, Davies S, Hoffman SJ. A roadmap for sustainably governing the global antimicrobial commons. Lancet. 2019 11 16; 394(10211):1788-1789. PMID: 31741444

Outterson K. A shot in the arm for new antibiotics. Nat Biotechnol. 2019 10; 37(10):1110-1112. PMID: 31578512

Rex JH, Fernandez Lynch H, Cohen IG, Darrow JJ, Outterson K. Designing development programs for non-traditional antibacterial agents. Nat Commun. 2019 07 31; 10(1):3416. PMID: 31366924; PMCID: PMC6668399; DOI: 10.1038/s41467-019-11303-9;

Barlam TF, Morgan JR, Kaplan WA, Outterson K, Pelton SI. Disproportionate Exposure to Antibiotics in Children at Risk for Invasive Pneumococcal Disease: Potential for Emerging Resistance and Opportunity for Antibiotic Stewardship. J Pediatric Infect Dis Soc. 2019 Mar 28; 8(1):63-65.View Related Profiles.

Morgan, Jake
Outterson, Kevin
Pelton, Stephen
Barlam, Tamar
Kaplan, Warren

PMID: 28992176

Kållberg C, Årdal C, Salvesen Blix H, Klein E, M Martinez E, Lindbæk M, Outterson K, Røttingen JA, Laxminarayan R. Introduction and geographic availability of new antibiotics approved between 1999 and 2014. PLoS One. 2018; 13(10):e0205166. PMID: 30325963; PMCID: PMC6191083; DOI: 10.1371/journal.pone.0205166;

Bhatti T, Lum K, Holland S, Sassman S, Findlay D, Outterson K. A Perspective on Incentives for Novel Inpatient Antibiotics: No One-Size-Fits-All. J Law Med Ethics. 2018 06; 46(1_suppl):59-65. PMID: 30146959

Årdal C, Baraldi E, Theuretzbacher U, Outterson K, Plahte J, Ciabuschi F, Røttingen JA. Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations. J Pharm Policy Pract. 2018; 11:8. PMID: 29632669; PMCID: PMC5885303; DOI: 10.1186/s40545-018-0135-0;

Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, Ouellette M, Outterson K, Patel J, Cavaleri M, Cox EM, Houchens CR, Grayson ML, Hansen P, Singh N, Theuretzbacher U, Magrini N. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018 03; 18(3):318-327. PMID: 29276051

Theuretzbacher U, Savic M, Årdal C, Outterson K. Market watch: Innovation in the preclinical antibiotic pipeline. Nat Rev Drug Discov. 2017 11; 16(11):744-745. PMID: 28983100

Årdal C, Baraldi E, Ciabuschi F, Outterson K, Rex JH, Piddock LJV, Findlay D. To the G20: incentivising antibacterial research and development. Lancet Infect Dis. 2017 08; 17(8):799-801. PMID: 28689703

Deak D, Powers JH, Outterson K, Kesselheim AS. The Fight Against Multidrug-Resistant Bacteria. Ann Intern Med. 2017 01 03; 166(1):79. PMID: 28030672; DOI: 10.7326/L16-0582;

Outterson K, McDonnell A. Antimicrobial Resistance: The Authors Reply. Health Aff (Millwood). 2016 10 01; 35(10):1936. PMID: 27702975

Outterson K, Rex JH, Jinks T, Jackson P, Hallinan J, Karp S, Hung DT, Franceschi F, Merkeley T, Houchens C, Dixon DM, Kurilla MG, Aurigemma R, Larsen J. Accelerating global innovation to address antibacterial resistance: introducing CARB-X. Nat Rev Drug Discov. 2016 09; 15(9):589-90. PMID: 27469032; DOI: 10.1038/nrd.2016.155;

Outterson K, Gopinathan U, Clift C, So AD, Morel CM, Røttingen JA. Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality. PLoS Med. 2016 Jun; 13(6):e1002043. PMID: 27299990; PMCID: PMC4907461; DOI: 10.1371/journal.pmed.1002043;

Deak D, Outterson K, Powers JH, Kesselheim AS. Progress in the Fight Against Multidrug-Resistant Bacteria? A Review of U.S. Food and Drug Administration-Approved Antibiotics, 2010-2015. Ann Intern Med. 2016 Sep 06; 165(5):363-72. PMID: 27239977; DOI: 10.7326/M16-0291;

Outterson K, McDonnell A. Funding Antibiotic Innovation With Vouchers: Recommendations On How To Strengthen A Flawed Incentive Policy. Health Aff (Millwood). 2016 May 01; 35(5):784-90. PMID: 27140983; DOI: 10.1377/hlthaff.2015.1139;

Rex JH, Outterson K. Antibiotic reimbursement in a model delinked from sales: a benchmark-based worldwide approach. Lancet Infect Dis. 2016 Apr; 16(4):500-5. PMID: 27036356; DOI: 10.1016/S1473-3099(15)00500-9;

Årdal C, Outterson K, Hoffman SJ, Ghafur A, Sharland M, Ranganathan N, Smith R, Zorzet A, Cohn J, Pittet D, Daulaire N, Morel C, Rizvi Z, Balasegaram M, Dar OA, Heymann DL, Holmes AH, Moore LS, Laxminarayan R, Mendelson M, Røttingen JA. International cooperation to improve access to and sustain effectiveness of antimicrobials. Lancet. 2016 Jan 16; 387(10015):296-307. PMID: 26603920; DOI: 10.1016/S0140-6736(15)00470-5;

Outterson K, Powers JH, Daniel GW, McClellan MB. Repairing the broken market for antibiotic innovation. Health Aff (Millwood). 2015 Feb; 34(2):277-85. PMID: 25646108; DOI: 10.1377/hlthaff.2014.1003;

Hoffman SJ, Outterson K, Røttingen JA, Cars O, Clift C, Rizvi Z, Rotberg F, Tomson G, Zorzet A. An international legal framework to address antimicrobial resistance. Bull World Health Organ. 2015 Feb 01; 93(2):66. PMID: 25883395; PMCID: PMC4339972; DOI: 10.2471/BLT.15.152710;

Hoffman SJ, Outterson K. INTRODUCTION: What Will It Take to Address the Global Threat of Antibiotic Resistance? J Law Med Ethics. 2015; 43 Suppl 3:6-11. PMID: 26243236; DOI: 10.1111/jlme.12267;

Hoffman SJ, Outterson K. What Will It Take to Address the Global Threat of Antibiotic Resistance? J Law Med Ethics. 2015; 43(2):363-8. PMID: 26242959; DOI: 10.1111/jlme.12253;

Outterson K. Clinical trial transparency--antidote to weaker off-label-promotion rules? N Engl J Med. 2014 Jul 3; 371(1):1-3. PMID: 24988551; DOI: 10.1056/NEJMp1402969;

Outterson K. The Drug Quality and Security Act--mind the gaps. N Engl J Med. 2014 Jan 9; 370(2):97-9. PMID: 24369048; DOI: 10.1056/NEJMp1314691;

Outterson K, Powers JH, Seoane-Vazquez E, Rodriguez-Monguio R, Kesselheim AS. Approval and withdrawal of new antibiotics and other antiinfectives in the U.S., 1980-2009. J Law Med Ethics. 2013; 41(3):688-96. PMID: 24088160; DOI: 10.1111/jlme.12079;

Outterson K. Regulating compounding pharmacies after NECC. N Engl J Med. 2012 Nov 22; 367(21):1969-72. PMID: 23134357; DOI: 10.1056/NEJMp1212667;

Outterson K. Punishing health care fraud--is the GSK settlement sufficient? N Engl J Med. 2012 Sep 20; 367(12):1082-5. PMID: 22970920

Huberfeld N, Leonard EW, Outterson K. Plunging into Endless Difficulties: Medicaid and Coercion in the Healthcare Cases. SSRN Electronic Journal. 2012. View Publication

Outterson K. Smoking and the First Amendment. N Engl J Med. 2011 Dec 22; 365(25):2351-3. PMID: 22149735; DOI: 10.1056/NEJMp1113011;

Outterson K. Higher First Amendment hurdles for public health regulation. N Engl J Med. 2011 Aug 18; 365(7):e13. PMID: 21812665; DOI: 10.1056/NEJMp1107614;

Outterson K, Pogge T, Hollis A. Combating Antibiotic Resistance Through the Health Impact Fund. SSRN Electronic Journal. 2011. View Publication
Frakt A, Outterson K. After the Deluge: Health Reform Without an Individual Mandate. 2011.
Selinger E, Outterson K, Whyte KP. Poverty Tourism, Justice and Policy. Public Integrity. 2011; 14(1). View Publication
Outterson K, Yevtukhova O. Germ Shed Management in the United States. 2011. View Publication

So AD, Gupta N, Brahmachari SK, Chopra I, Munos B, Nathan C, Outterson K, Paccaud JP, Payne DJ, Peeling RW, Spigelman M, Weigelt J. Towards new business models for R&D for novel antibiotics. Drug Resist Updat. 2011 Apr; 14(2):88-94. PMID: 21439891; DOI: 10.1016/j.drup.2011.01.006;

Outterson K, Orentlicher D, Robertson C, Pasquale FA. William H. Sorrell, Attorney General of Vermont, et al. v. IMS Health Inc., et al. - Amicus Brief in Support of Petitioners. SSRN Publication Journal. 2011. View Publication

Kesselheim AS, Outterson K. Improving antibiotic markets for long-term sustainability. Yale J Health Policy Law Ethics. 2011; 11(1):101-67. PMID: 21381513

Outterson K. Death from the Public Domain?. Texas Law Review. 2010; 87.
Whyte KP, Selinger E, Outterson K. Poverty Tourism and the Problem of Consent . Journal of Global Ethics. 2010; 7(3). View Publication

Outterson K, Powers JH, Gould IM, Kesselheim AS. Questions about the 10 x '20 Initiative. Clin Infect Dis. 2010 Sep 15; 51(6):751-2; author reply 754-5. PMID: 20731566; DOI: 10.1086/655955;

Kesselheim AS, Outterson K. Fighting antibiotic resistance: marrying new financial incentives to meeting public health goals. Health Aff (Millwood). 2010 Sep; 29(9):1689-96. PMID: 20820028; DOI: 10.1377/hlthaff.2009.0439;

Outterson K, Light DW. Blackwell Companions to Philosophy (Kuhse H, Singer P, eds.). A Companion to Bioethics, Second Edition. 2010; 417-429. View Publication
Outterson K. The Legal Ecology of Resistance: The Role of Antibiotic Resistance in Pharmaceutical Innovation. Cardozo Law Review. 2009.

Outterson K, Kesselheim AS. How Medicare could get better prices on prescription drugs. Health Aff (Millwood). 2009 Sep-Oct; 28(5):w832-41. PMID: 19643778; DOI: 10.1377/hlthaff.28.5.w832;

Outterson K, Selinger E. The Ethics of Poverty Tourism. Environmental Philosophy. 2009; 7(2):93-113. View Publication
Outterson K. Research Handbook on Intellectual Property Law and the WTO ( Carlos C, ed.). Disease-Based Limitations on Compulsory Licenses Under Articles 31 and 31 bis. 2009. View Publication
Outterson K. The End of Reparations Talk? - Reparations in an Obama World. Kansas Law Review. 2009; 57:935.
Outterson K. Import Safety: Regulatory Governance in the Global Economy (Coglianese C, Finkel A, Zaring S, eds.). Import Safety Rules And Generic Drug Markets. 2009. View Publication

Outterson K. Introduction: pharmaceutical innovation: law & the public's health. J Law Med Ethics. 2009; 37(2):173-5. PMID: 19493064; DOI: 10.1111/j.1748-720X.2009.00363.x;

Outterson K. 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. Am J Law Med. 2009; 35(2-3):247-52. PMID: 19697748

Outterson K. Antibiotic Resistance and Antibiotic Development - Author’s Reply. Lancet Infectious Diseases. 2008; 8(4):212-214. View Publication

Outterson K. Should access to medicines and TRIPS flexibilities be limited to specific diseases? Am J Law Med. 2008; 34(2-3):279-301. PMID: 18697695

Outterson K, Kesselheim AS. Market-based licensing for HPV vaccines in developing countries. Health Aff (Millwood). 2008 Jan-Feb; 27(1):130-9. PMID: 18180488; DOI: 10.1377/hlthaff.27.1.130;

Outterson K, Samora JB, Keller-Cuda K. Will longer antimicrobial patents improve global public health? Lancet Infect Dis. 2007 Aug; 7(8):559-66. PMID: 17646029

Outterson K. Access to Global Disease Innovation. WHO Inter Governmental Working Group. 2006. View Publication
Outterson K, Smith R. Counterfeit Drugs: The Good, the Bad and the Ugly. Albany Law Journal of Science and Technology. 2006; 16(3):525.
Outterson K. The Power Of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing (Cohen J, Illingworth P, Schuklenk U, eds.). Fair Followers: Expanding Access To Generic Pharmaceuticals For Low- and Medium Income Populations. 2006.

Outterson K. Patent buy-outs for global disease innovations for low- and middle-income countries. Am J Law Med. 2006; 32(2-3):159-73. PMID: 16927608

Outterson K. Agony in the Antipodes: The Generic Drug Provisions of the Australia-USA Free Trade Agreement. Journal of Generic Medicines. 2005; 2(4):316-326. View Publication
Outterson K. The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Intellectual Property Law. University of Pittsburgh Law Review. 2005; 67:67-123. View Publication
Outterson K. US Senate Health, Education, Labor, & Pensions Committee Hearing on Drug Importation - Response to Dean Arnold. SSRN Electronic Journal. 2005. View Publication

Outterson K. Tragedy and remedy: reparations for disparities in black health. DePaul J Health Care Law. 2005; 9(1):735-91. PMID: 17061385

Outterson K. Nonrival Access to Pharmaceutical Knowledge. SSRN Electronic Journal. 2005. View Publication

Outterson K. Pharmaceutical arbitrage: balancing access and innovation in international prescription drug markets. Yale J Health Policy Law Ethics. 2005; 5(1):193-291. PMID: 15742578

Outterson K. The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Global Public Health . University of Pittsburgh Law Review . 2005; 67:67-123.
Outterson K. The Vanishing Public Domain: Antibiotic Resistance, Pharmaceutical Innovation and Intellectual Property Law. University of Pittsburgh Law Review . 2005; 67:67-123.
Outterson K. Resolving Dysfunctional Pharmaceutical Arbitrage and Counterfeiting through the Proposed Hubbard-Love R&D Treaty. SSRN Electronic Journal. 2004. View Publication
Outterson K. Slave taxes. Should America Pay?: Slavery and the Raging Debate over Reparations (Winbush R, ed.). 2003.

Outterson K, Butler JL. Disease management: legal strategies for the next generation of managed care. J Health Law. 1998; 31(3):291-314. PMID: 10620832

This graph shows the total number of publications by year, by first, middle/unknown, or last author.

Bar chart showing 85 publications over 21 distinct years, with a maximum of 9 publications in 2011

Bar chart showing 85 publications over 21 distinct years, with a maximum of 9 publications in 2011

Year	Publications
1998	1
2003	1
2004	1
2005	8
2006	4
2007	1
2008	3
2009	8
2010	5
2011	9
2012	3
2013	2
2014	1
2015	5
2016	6
2017	4
2018	3
2019	6
2020	5
2021	8
2022	1

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