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

Authors

Kevin Outterson, Boston Univeristy School of LawFollow
John H. Powers, George Washington University
Enrique Seoane, International Center for Pharmaceutical Economics and Policy
Rosa Rodriguez-Monguio, University of Massachusetts Amherst
Aaron S. Kesselheim, Brigham and Women's Hospital/Harvard Medical SchoolFollow

Author granted license

Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International

Document Type

Article

Publication Date

Fall 2013

ISSN

1748-720X

Publisher

Sage

Language

en-US

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 Our data demonstrates that many of the new molecular entity (NME) antibioticsintroduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes.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

Comments

Boston University School of Law, Law and Economics Research Paper No. 13-47

Recommended Citation

Kevin Outterson, John H. Powers, Enrique Seoane, Rosa Rodriguez-Monguio & Aaron S. Kesselheim, Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009 , in 41 Journal of Law, Medicine and Ethics 688 (2013).
Available at: https://scholarship.law.bu.edu/faculty_scholarship/6