Approval and Withdrawal of New Antibiotics and Other Antiinfectives in the U.S., 1980-2009
Boston University School of Law
John H Powers
George Washington University
Ohio State University
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
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 Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes.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, resistanceAccepted Paper Series
Date posted: September 18, 2013 ; Last revised: February 26, 2014
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