FDA’s “Strategic Approach for Combatting AMR”
On Sep 14th, the USA Food and Drug Administration Commissioner, Dr Scott Gottlieb, outlined the FDA’s ‘Strategic Approach for Combatting AMR’. If you have a spare 98 minutes, you can find the full announcement here. The FDA, and equivalent bodies in other countries, are highly influential because they are closely involved at every stage of antimicrobial use – from pre-market development, to clinical trials, through to post-market safety and surveillance. They are also important in supplementing the activity of national action plans as well as non-government organisations. The FDA recognised that solving the AMR problem requires a multi-disciplinary approach, and highlighted four key areas that will guide their strategy into 2019.
1. Economic – “Push” incentives to encourage new and alternative antimicrobial development, including greater funding and shortened time to clinical trials; but also, “pull” incentives to attract more investment into the field. An interesting suggestion is the implementation of subscription fees for developers of antimicrobials with high clinical value, thereby decoupling the worth of the product from its sales volume.
2. Stewardship – “We can’t count on outracing drug resistance, but we can use stewardship and science to slow its pace”. Pleasingly, it was recognised that, as well as providing guidance in the application of antimicrobials in human health, veterinary and agricultural settings are also important. This aspect also includes support for the development of technology to assist with diagnostics through detection of biomarkers to guide appropriate use of antimicrobials.
3. Surveillance – Particulalry to help determine “when” microbes develop resistance. There is a recognition that all manner of datasets are collected and communicated differently, making any holistic assessment difficult. The FDA suggested a standardised, centralised information system to guide decision making and knowledge dissemination.
4. Regulation – Specifically, how to appropriately manage public-private partnerships. The FDA would like to achieve an annual list of regulatory science initiatives specific for antimicrobial products. This includes “new efforts to create drug development tools or standards for use by industry to better meet patient needs”.