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Antimicrobial drug development--the past, the present, and the future

J H Powers1

  • 1US Food and Drug Administration, Rockville, MD 20850, USA. POWERSJOH@cder.fda.gov

Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases
|November 4, 2004
PubMed

Insights

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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