IDSA presented testimony to a US Food and Drug Administration (FDA) panel on April 28 to address the increasingly troublesome issue of antimicrobial resistance. FDA’s hearing is a promising sign that the agency is moving forward to address antimicrobial policy issues after years of delays.
In their testimony, John G. Bartlett, MD, FIDSA, chair of IDSA’s Antimicrobial Availability Task Force, Neil Fishman, MD, chair of the Society’s Antimicrobial Resistance Work Group, and Robert Guidos, IDSA’s director of public policy and government relations, warned of a potential impending health crisis due to decreases in research and development, impediments and uncertainty in FDA’s antibacterial drug review process, and the lack of federal funding and attention paid to this important medical/public health problem. They set forth numerous recommendations aimed at reducing the impact of antimicrobial resistance on the public and galvanizing the development of new products to address the increase in antibacterial resistant infections.
The Society called for reestablishing consistency, predictability, and timeliness in FDA’s antibacterial drug review process while providing economic and other incentives to spur the development of new antibacterial products. IDSA called upon FDA to commission a study to determine which incentives might work best.
IDSA also supports the creation of a strategic research plan for antimicrobial resistance to establish priorities and strengthen collaborations between FDA, the National Institutes of Health, the Centers for Disease Control and Prevention, the Departments of Agriculture, Veteran Affairs, and Defense, and the Environmental Protection Administration. IDSA also proposes improving data collection on clinical, veterinary, and human antibacterial use.
Improving surveillance efforts to detect and monitor the emergence of resistance is especially crucial given the diminishing numbers of antibacterial drugs, IDSA leaders said.
Other solutions proposed by the Society include educating physicians and patients about the appropriate use of antibacterial drugs and preventing antibiotics of critical consequence to human health from being used in agriculture, as well as developing better options for antibacterial drug use in animals and agriculture.
In December 2000, FDA’s Task Force on Antimicrobial Resistance issued a report containing priority recommendations the agency was to implement to address the antimicrobial resistance and pipeline problems. Few of these recommendations have been implemented to date. Such past inaction on FDA’s part has raised questions about the agency’s commitment to address the brewing antimicrobial resistance crisis—a problem that infectious diseases physicians believe should be a significant priority of the U.S. government.
"IDSA leaders hope that the hearing signals a turning point in FDA’s level of commitment and a demonstration of agency leaders’ desire to tackle these critical patient safety and public health problems," Guidos said. "To confirm this, FDA should act immediately to dedicate the resources and staff time necessary to implement the recommendations of its own task force as well as the recommendations that IDSA has proposed."
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