FDA launches new method for antibiotic prescription
pharmafile | December 14, 2017 | News story | Medical Communications | antibiotic resistance, biotech, drugs, pharma, pharmaceutical
The fight against the growth of antibiotic resistance has become a major talking point internationally in recent years and the FDA has announced its own method to aid the effort.
It has launched a website that will provide health care professionals (HCPs) with the most recent information on bacterial and fungal infections responsiveness to specific forms of treatment. The initiative was called for as part of the 21st Century Cures Act, passed with bipartisan support at the end of last year.
The repository of information on antibiotics will not only allow HCPs to check against the treatment they should use for particular infections but will also allow a streamlining of labels.
In previous methods of updating the label for treatments, the manufacturer would have to apply to the FDA for it to be updated on a case-by-case basis.
This then would allow antimicrobial susceptibility tests (ASTs) manufacturers to update its testing criteria for the drug. ASTs are used by physicians to determine the appropriate treatment for a particular infection. The tests determine whether bacteria or fungi are responding to certain treatments, dependent on certain criteria – otherwise known as breakpoints.
These steps necessitated changes to label every time efficacy changed or expanded, whereas now drug labels will simply point HCPs towards the FDA’s new website.
FDA Commissioner Scott Gottlieb said of the innovation: “When you’re treating critically ill patients, you want as much information as possible about the pathogen your patient is fighting and the susceptibility of that pathogen to various treatments. Prescribing a drug that’s only going to be met with resistance from the bacteria or fungus it’s intended to treat doesn’t help that patient, and it has broader public health consequences that cannot be ignored. Under the old approach, it took too long to update each individual drug’s labelling with information needed for susceptibility testing and it was clear a more centralized approach was needed. Our new tool is aimed at making this process more efficient and informed.”
The broader public health mentioned by Gottlieb is the rise in resistance to certain antibiotics – treating patients with antibiotics or antifungals that are unlikely to be effective only increases the likelihood of mutation to develop further resistance.
However, offering more information to doctors is only part of the battle – another is antibiotic use in animals. Only last week the FDA revealed that it had recorded the first decline in year-to-year sales of antibiotics for use in livestock. In total, sales fell by 14% to record the lowest levels since 2009.
Ben Hargreaves
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