FDA Task Force on Antimicrobial Resistance: Key Recommendations and Report.

摘要

Antibiotic resistance (AR) is a growing problem that has recently been identified as a major public health threat and priority by several expert committees, including those of the Institute of Medicine, the American Society for Microbiology, as well as by the U.S. Office of Technology Assessment. The continuing emergence of difficult to treat or untreatable nosocomial pathogens such as multidrug resistant Klebsiella, vancomycin resistant enterococci (VRE), and Staphylococcus aureus with intermediate susceptibility to vancomycin and other glycopeptide antibiotics (GISA) threaten the lives of hospitalized individuals and those with chronic conditions and add considerably to health care costs. Even more disconcerting, common community acquired and food borne infections of humans, including those due to pathogens such as Streptococcus pneumoniae, S. aureus, Salmonella and Campylobacter species, Mycobacterium tuberculosis, Neisseria gonorrhoeae and HIV-all show trends toward increasing resistance to standard available therapies. Resistant organisms and their genes cross national and regulatory boundaries involving foods, animals, and humans. FDA has key roles in helping facilitate the development of drugs, vaccines, devices and diagnostics as well as their safe and effective use. This document presents the major results of the Task Forces deliberations and represents the Agencys current thinking about how it can best address the antimicrobial resistance problem.