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

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 Our data demonstrates that many of the new molecular entity (NME) antibiotics introduced in the last 3 decades were withdrawn from the market, at more than triple the rate of other drug classes.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