Abstract

http://ssrn.com/abstract=2326765
 


 



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


Kevin Outterson


Boston University School of Law

John H Powers


George Washington University

Enrique Seoane


Ohio State University

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

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

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 Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes.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

Number of Pages in PDF File: 10

Keywords: antibiotics, innovation, resistance

Accepted Paper Series





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Date posted: September 18, 2013 ; Last revised: February 26, 2014

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: http://ssrn.com/abstract=2326765

Contact Information

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
Ohio State University ( email )
500 W 12th Avenue
Columbus, OH 43210
United States
614 209 3907 (Phone)
HOME PAGE: http://www.pharmacy.ohio-state.edu/programs/padm/faculty/seoane/
Rosa Rodriguez-Monguio
University of Massachusetts ( email )
Amherst, MA 01003
United States
Aaron S. Kesselheim
Brigham and Women's Hospital/Harvard Medical School ( email )
1620 Tremont St
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 )
124 Mount Auburn Street
Suite 520N
Cambridge, MA 02138
United States

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