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

10 Pages Posted: 18 Sep 2013 Last revised: 8 Aug 2015

Kevin Outterson

Boston University School of Law

John H Powers

George Washington University

Enrique Seoane

Director International Center for Pharmaceutical Economics and Policy

Rosa Rodriguez-Monguio

University of Massachusetts

Aaron S. Kesselheim

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

Date Written: September 16, 2013

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 Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes.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

Suggested Citation

Outterson, Kevin and Powers, John H and Seoane, Enrique and Rodriguez-Monguio, Rosa and Kesselheim, Aaron S., Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009 (September 16, 2013). Journal of Law, Medicine and Ethics, p. 688, Fall 2013; Boston Univ. School of Law, Law and Economics Research Paper No. 13-47. Available at SSRN: https://ssrn.com/abstract=2326765

Kevin Outterson (Contact Author)

Boston University School of Law ( email )

765 Commonwealth Avenue
Boston, MA 02215
United States

John H Powers

George Washington University ( email )

2121 I Street NW
Washington, DC 20052
United States

Enrique Seoane-Vazquez

Director International Center for Pharmaceutical Economics and Policy ( email )

179 Longwood Avenue
Boston, MA 02115
United States

Rosa Rodriguez-Monguio

University of Massachusetts ( email )

Department of Operations and Information Managemen
Amherst, MA 01003
United States

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

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Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.drugepi.org/portal

Harvard University - Edmond J. Safra Center for Ethics ( email )

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Suite 520N
Cambridge, MA 02138
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