Annals of the New York Academy of Sciences
-
Ann. N. Y. Acad. Sci. · Sep 2014
ReviewThe risk/benefit of predicting a post-antibiotic era: is the alarm working?
There have been concerns about antimicrobial resistance since the first widespread use of antibiotics in humans. More recently, this concern has grown and become the focus of clinical, scientific, and political activity. In part, the political interest is a consequence of publicizing a bleak picture of a post-antibiotic world. ⋯ Many governments now use a risk assessment approach to identify security concerns, based on reasonable worst-case scenarios. There is no doubt that for effective policy-based action to occur, antimicrobial resistance needs to be seen as a national and international security priority, particularly as the major cost of inaction will mostly be felt in the future. We conclude that presenting the evidence in a manner that is used to encourage prioritization of security policy is not only justified, it is essential to drive action in this area.
-
Ann. N. Y. Acad. Sci. · Sep 2014
ReviewThe evolution of the regulatory framework for antibacterial agents.
The rising tide of antibacterial resistance and the lack of a diverse, vibrant pipeline of novel antibacterial agents is a global crisis that impairs our ability to treat life-threatening infections. The recent introduction of a tiered approach to the regulatory framework in this area offers one path to resolving some of the challenges. ⋯ There are limitations to these pathways, and they are not easy to implement, but making reliable noninferiority-based approaches available is critical to reinvigorating the global antibiotic pipeline. With the recognition of these ideas by key regulatory authorities in recent guidance, the next challenges in this area will focus on interpretive breakpoints, the extent of data in the prescribing information, ensuring that multiple agents can be progressed, and the challenge of the antibiotic business model.