FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"

Since Alexander Fleming has found the effect of Penicillin on bacteria in 1928, many further antibiotics or similar medicinal products were developed to treat patients who have infectious diseases. But approximately ten years after starting with industrial production of antibiotics, the first infectious organisms adapted to them, making the drugs less effective. According to CDC information, every year at least 2 million Americans become infected with bacteria that are resistant to antibiotics. And at least 23,000 die every year as a direct result of these infections. The WHO called it "an increasingly serious threat to global public health" and "A post-antibiotic era - in which common infections and minor injuries can kill - far from being an apocalyptic fantasy, is instead a very real possibility for the 21st Century."

Therefore, several countries started activities to reduce and control antibiotic / antimicrobial resistance. One part of these activities is the evaluation of microbiological data of antibacterial drugs.

Now the FDA published a Guidance for Industry "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation" to assist the concerned companies and institutions in the development, analysis, and presentation of microbiology data during antibacterial drug development. Additionally this document should reflect the current thinking what a microbiology development programme should include to support approval of antibacterial drugs as well as microbiology information collected after approval. The document comprises the following items:

A. Early Development Nonclinical Considerations
1. Antibacterial Spectrum of Activity
2. Mechanism of Action
3. Intracellular Antimicrobial Concentration Assessment
4. Resistance Studies

B. In Vitro Antimicrobial Susceptibility Test Methods During Drug Development
1. Early Clinical Development
2. Provisional Antibacterial Susceptibility Test Interpretive Criteria
3. Establishing In Vitro Antibacterial Susceptibility Test Interpretive Criteria
4. Quality Control Parameters

C. Other Considerations
1. First and Second Lists of Target Bacteria in Labeling
2. Antibacterial Interactions and Fixed Combination Studies
3. Additional Nonclinical Studies of Antibacterial Drugs
4. Animal Models of Infection
5. Microbiology Information Collected in Clinical Trials
6. Electronic Submission of Microbiology Information
7. Postmarketing Microbiology Information

Five appendices complete the guidance with information about bacterial isolate selection and studies of antibacterial activities, study reports of spectrum of activity and resistance and more.

For more details see the complete guideline "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation".

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