Boston University School of Law

Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009

Journal of Law, Medicine and Ethics, p. 688, Fall 2013
Boston University School of Law Working Paper
13-47
(September 30, 2013)


Kevin Outterson
Boston University School of Law

John H. Powers
George Washington University

Enrique Seoane
Ohio State University

Rosa Rodriquez-Monguio
University of Massachusetts

Aaron S. Kesselheim
Brigham and Women's Hospital / Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics

 

Abstract

Concerns about a dearth of antibiotic innovation have spurred calls for incentives to speed the development of new antibiotics. Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes. Adjusted for these withdrawals, the net introduction of NME antibiotics is not as troubling of a trend. The reduction in NME antibiotics was partially offset by a surge in the introduction of NME antiretrovirals for HIV/AIDS and other drug classes (such as cardiovascular drugs) posted similar declines.

These data suggest that the reasons for changes in antibiotic innovation are complex and policymakers should be focused on the clinical quality of the new drugs, not just the raw number of introductions.

 

Keywords: antibiotics, innovation, resistance

 

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Kevin Outterson Contact Information
Email: mko@bu.edu

Boston University School of Law
765 Commonwealth Ave
Boston, MA 02215 USA
Phone: (617) 353-3103

John H. Powers Contact Information
Email: powersjohn@mail.nih.gov

George Washington University

2121 I Street NW
Washington, DC 20052

Enrique Seoane Contact Information
Email: Enrique.Seoane-Vazquez@mcphs.edu

Ohio State University

500 W 12th Avenue
Columbus, OH 43210
United States
614 209 3907 (Phone)

Rosa Rodriguez-Monguio Contact Information
Email: rmonguio@schoolph.umass.edu

University of Massachusetts
Amherst, Massachusetts

Aaron S. Kesselheim Contact Information
Email: akesselheim@partners.org

Brigham and Women's Hospital / Harvard Medical School; Harvard University - Edmond J. Safra Center for Ethics


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