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Published on: May 21, 2018
Antimicrobial drug development--the past, the present, and the future
1US Food and Drug Administration, Rockville, MD 20850, USA. POWERSJOH@cder.fda.gov
Summary
Antimicrobial resistance has been a persistent challenge since the 1940s, with limited new drug classes emerging. This review explores historical hurdles, economic factors, and regulatory solutions in antimicrobial development.
Area of Science:
- Microbiology
- Pharmacology
- Drug Development
Background:
- Antimicrobial resistance (AMR) emerged with early antimicrobial use in the 1940s.
- New antimicrobial classes were developed through the 1960s, but options for severe infections are now limited.
- Discovering novel antimicrobial classes has been challenging for over 40 years.
Observation:
- The current landscape of antimicrobial discovery is constrained by historical challenges.
- Economic realities within the pharmaceutical industry significantly influence antimicrobial development.
- Regulatory pathways and processes impact the availability of new antimicrobial agents.
Findings:
- This paper reviews the historical trajectory of antimicrobial drug development.
- It analyzes the persistent difficulties in identifying and developing new antimicrobial classes.
- The economic and regulatory environments are key determinants of the present state of antimicrobial R&D.
Implications:
- Understanding these challenges is crucial for addressing the global AMR crisis.
- Potential solutions, including streamlined regulatory processes by agencies like the US FDA, are discussed.
- Balancing innovation with public health protection is essential for future antimicrobial therapies.
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