LAUSR

Regulatory guidelines are in place across the world to ensure that approval of antibiotics is consistent with current scientific understanding of quality, efficacy and safety including minimizing the risk of the development of antibiotic resistance. We suggest the regulatory process is fit for purpose and does indeed approve products that are safe for use with regard to development of antibiotic resistance. However, we maintain that in order to preserve the longevity of antibiotics, treatment should be based on an established diagnosis and normally only antibiotics authorized for the diagnosed indication and indicated bacteria are used. Furthermore, susceptibility testing should be carried out whenever possible. Despite a general acceptance that antibiotic resistance is a significant issue, antibiotics can still receive a marketing authorization without a sponsor having to generate a clinical breakpoint. The consequence of this is that for many antibiotics we have no measure of what is resistant and what is susceptible at the approved dose. We argue that the time is right for all approvals of new or existing antibiotics to have independently agreed clinical breakpoints, as part of the regulatory process, without which talk of resistance is somewhat meaningless. This is relevant not only for novel antibiotics but also for generic compounds.