Designing Development Programs for Non-Traditional Antibacterial Agents

Nature Communications (2019) 10:3416 DOI: 10.1038/s41467-019-11303-9

Boston Univ. School of Law, Public Law Research Paper No. #19-17 (2019)

11 Pages Posted: 24 Sep 2019

See all articles by John H. Rex

John H. Rex

F2G Limited

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania

I. Glenn Cohen

Harvard Law School

Jonathan J. Darrow

Harvard Medical School

Kevin Outterson

Boston University School of Law

Date Written: 2019

Abstract

In the face of rising rates of antibacterial resistance, many responses are being pursued in parallel, including ‘non-traditional’ antibacterial agents (agents that are not small-molecule drugs and/or do not act by directly targeting bacterial components necessary for bacterial growth). In this Perspective, we argue that the distinction between traditional and nontraditional agents has only limited relevance for regulatory purposes. Rather, most agents in both categories can and should be developed using standard measures of clinical efficacy demonstrated with non-inferiority or superiority trial designs according to existing regulatory frameworks. There may, however, be products with non-traditional goals focused on population-level benefits that would benefit from extension of current paradigms. Discussion of such potential paradigms should be undertaken by the development community.

Keywords: antibacterial resistance, antibacterial agents

JEL Classification: I15, I18, I19

Suggested Citation

Rex, John H. and Lynch, Holly Fernandez and Cohen, I. Glenn and Darrow, Jonathan J. and Outterson, Kevin, Designing Development Programs for Non-Traditional Antibacterial Agents (2019). Nature Communications (2019) 10:3416 DOI: 10.1038/s41467-019-11303-9, Boston Univ. School of Law, Public Law Research Paper No. #19-17 (2019), Available at SSRN: https://ssrn.com/abstract=3458531 or http://dx.doi.org/10.2139/ssrn.3458531

John H. Rex

F2G Limited ( email )

Chesire
United Kingdom

Holly Fernandez Lynch

Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania ( email )

423 Guardian Drive
Philadelphia, PA 19104
United States

I. Glenn Cohen

Harvard Law School ( email )

1525 Massachusetts Avenue
Griswold Hall 503
Cambridge, 02138
United States

Jonathan J. Darrow

Harvard Medical School ( email )

25 Shattuck St
Boston, MA 02115
United States

Kevin Outterson (Contact Author)

Boston University School of Law ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States

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