Legal and Regulatory Approaches

ISSUE: The Centers for Disease Control and Prevention (CDC) cannot mandate states to reform laws regarding reporting, but must rely on education, persuasion, and invitation.

OPTIONS:

  • Exploring whether increased resistance and rapid diminution of effectiveness of existing antibiotics might justify awarding greater authority to the CDC to monitor and enforce legal duties regarding resistance, and consideration of the means by which this might be accomplished.

  • Considering ways to integrate issues of resistance into formulary development processes.

ISSUE: Some existing products seem to have activity against resistant pathogens, but since this efficacy has not been documented, such indications do not appear in their labeling.

OPTIONS:

  • Developing alternative ways to define efficacy—for example, surrogate markers, in vitro technologies, and animal models—to address the lack of well defined populations for clinical trials.

  • Exploring the possibility of congressional authorization to extend patents for such products, and the relevance of recent legislation adding six months of exclusivity when the Department of Health and Human Services requests pediatric studies of an existing product, with the recognition that this topic is complex and difficult.

ISSUE: There is ambiguity as to whether requests for registration of antibiotics for use on agricultural products that are exported are governed by the environmental clauses or the food safety requirements of the North American Free Trade Agreement and/or the General Agreements on Tariffs and Trade. Nor does antibiotic resistance appear to be incorporated explicitly into discussions of food safety and the regulation and monitoring of imports.

OPTION: Collaborative dialogue, perhaps led by the World Health Organization and including representation from the World Trade Organization, European Union, and U.S. Departments of State and of Commerce.



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