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Development of drugs for antimicrobial-resistant pathogens
1Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA. powersjoh@cder.fda.gov
Current Opinion in Infectious Diseases
|November 19, 2003
Summary
Antimicrobial resistance is a growing concern, necessitating new drug development and responsible use of existing antimicrobial agents. Balancing innovation with prudent stewardship is key to preserving drug effectiveness against resistant pathogens.
Area of Science:
- Microbiology
- Infectious Diseases
- Pharmacology
Background:
- Antimicrobial resistance (AMR) has been linked to antimicrobial use for over 50 years.
- Multidrug-resistant organisms pose significant treatment challenges due to limited therapeutic options.
- Pharmaceutical companies are reducing investment in the development of new antimicrobial agents.
Purpose of the Study:
- To review initiatives aimed at addressing antimicrobial resistance.
- To highlight strategies for developing new antimicrobial drugs and promoting appropriate use of existing ones.
Main Methods:
- Review of US Food and Drug Administration (FDA) initiatives for identifying priority pathogens.
- Examination of streamlined drug development processes for antimicrobial agents.
- Analysis of federal agency programs for clinician and public education on antimicrobial stewardship.
Main Results:
- The FDA is identifying critical pathogens and facilitating antimicrobial drug development.
- Federal agencies are implementing educational programs to promote appropriate antimicrobial use.
- There is a recognized need to balance the development of novel antimicrobial agents with the preservation of current therapies.
Conclusions:
- Addressing antimicrobial resistance requires a dual approach: fostering new drug innovation and ensuring prudent use of existing antimicrobial agents.
- Striking a balance between promoting new antimicrobial development and preserving the efficacy of current drugs is essential for public health.
- Effective antimicrobial stewardship programs are vital to combat the growing threat of multidrug-resistant organisms.