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Policy issues concerning antimicrobials: problems with the regulatory process governing their introduction.
Hospital Formulary
|April 10, 1985
Summary
Governmental approval for new antimicrobials is lengthy and cumbersome. A specialized review process is needed due to unique antimicrobial characteristics, proposing modifications to pre- and postmarketing strategies.
Area of Science:
- Pharmacology
- Regulatory Science
- Infectious Diseases
Background:
- Current drug approval processes are criticized for being lengthy and cumbersome by clinicians, industry, and observers.
- Existing regulatory frameworks may not be fully suitable for the unique nature of antimicrobial drugs.
Purpose of the Study:
- To highlight the inadequacy of current governmental regulatory processes for antimicrobial drug approval.
- To propose modifications for the pre- and postmarketing approval of antimicrobials.
Main Methods:
- Analysis of existing drug approval processes.
- Identification of qualitative differences between antimicrobials and other drugs.
- Formulation of proposed changes to regulatory procedures.
Main Results:
- The current drug approval process is deemed inappropriate for antimicrobials.
- Antimicrobials possess unique characteristics necessitating a tailored review process.
Conclusions:
- A specialized regulatory review, distinct from that for other drugs, is essential for antimicrobials.
- Modifications to both pre- and postmarketing approval stages are recommended to improve efficiency and appropriateness.