Development of drugs for antimicrobial-resistant pathogens.
OBJECTIVE
Clinicians have noted an association between antimicrobial resistance and antimicrobial use since the introduction of these agents over 50 years ago. The problem of resistance becomes more pressing, however, when organisms acquire resistance mechanisms to multiple antimicrobial agents. Treatment options are limited for some multidrug-resistant organisms. Antimicrobial resistance is a driving force for the need for new antimicrobial agents, especially for these multidrug-resistant pathogens. At the same time, large pharmaceutical companies have indicated that they are devoting fewer resources to antimicrobial drug development.


RESULTS
This article will review initiatives by the US Food and Drug Administration to identify problem pathogens for which drug development is of most public health importance, and to streamline the drug development process for antimicrobial agents. This article will also touch upon initiatives by federal agencies to implement programs to educate clinicians and the public on the appropriate use of antimicrobial agents to preserve the usefulness of currently marketed drugs.


CONCLUSIONS
The most effective way to address the issues of antimicrobial resistance appears to be striking a balance between promoting new drug development and the prudent use of older agents to preserve the usefulness of currently marketed products.
Powers
John H
JH
Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA. powersjoh@cder.fda.gov
D015195:Drug Design; D004345:Drug Industry; D004352:Drug Resistance, Microbial; D018432:Drug Resistance, Multiple