This article represents the views of the author and not necessarily those of the U.S. Food and Drug Administration.
Antimicrobial drug development – the past, the present, and the future
Version of Record online: 11 NOV 2004
Clinical Microbiology and Infection
Volume 10, Issue Supplement s4, pages 23–31, November 2004
How to Cite
Powers, J. H. (2004), Antimicrobial drug development – the past, the present, and the future. Clinical Microbiology and Infection, 10: 23–31. doi: 10.1111/j.1465-0691.2004.1007.x
- Issue online: 11 NOV 2004
- Version of Record online: 11 NOV 2004
- Antimicrobial resistance;
- drug development;
- drug design;
- clinical trials
Antimicrobial resistance has been an issue since the introduction into clinical use of the first agents in the 1940s. Although the discovery and development of new classes of antimicrobials through the 1960s presented an array of treatment options, these options for some serious and life-threatening infectious diseases may now be more limited. This paper examines the history of antimicrobial development, showing how the challenges in discovering new classes of drugs have been with us for the last 40 years. The present state of antimicrobial discovery and development is shaped by these challenges as well as by the economic realities of the pharmaceutical industry. This paper also discusses some of the regulatory considerations in antimicrobial drug development, and presents some potential solutions to the challenges inherent in antimicrobial drug development, including steps taken by the US Food and Drug Administration to streamline the drug review process for antimicrobial agents while maintaining the standards necessary to protect and promote the health of the public.