The scope and objective of GFI #152 remains the same as the original document published in 2003, but the regulator has stated that the current versionBetter aligns with today’s scientific knowledge and clinical practices in human medicine.
Guidance updates include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and an overhaul of the classification of antimicrobial drug classes as extremely important , very important or important depending on the new updated ranking criteria.
In the original GFI #152, the United States Food and Drug Administration (FDA) weighted its classification criteria on drugs used to treat enteric pathogens caused by foodborne illness. “With improved scientific knowledge of antimicrobial resistance and medical advances since 2003, the FDA now believes that the importance of a class of antimicrobials should be ranked according to their use in human medicine, regardless of mode of disease transmission. For this reason, the new criteria emphasize the drug’s usefulness for treating bacterial infections in humans, the severity of those infections, and the availability of alternative treatment options.
Other proposed changes, he continued, include new text to address antimicrobial drugs that are not medically important (NMIs) and updated exposure assessment tables based on a extensive collaboration with the US Department of Agriculture’s Food Safety Inspection Service (FSIS) and Economic Research Service (FSIS).ERS).
Regarding proposed revisions to GFI #152, the agency said it considered feedback from its 2020 concept paper and its public meeting on a potential approach to categorizing antimicrobial drugs based on their importance in human medicine.
The FDA accepts comments on the draft guidelines for 90 days.
US Farm Animal Antimicrobial Sales
This month, the agency’s Center for Veterinary Medicine (CVM) also released the latest data On antimicrobials sold or distributed in 2021 in the United States for use in farm animals.
The report shows that domestic sales and distribution of medically important antimicrobial drugs approved for use in farm animals decreased by less than 1% between 2020 and 2021.
Since the significant decline in sales volume in 2017, annual sales of medically important antimicrobials have remained at reduced levels. Compared to 2015, the peak year for sales, 2021 volumes are down 38%, the publication notes.
“These sales and distribution data only reflect the total amount of antimicrobial drugs entering the market and do not represent the amount or how these drugs are ultimately used. For example, veterinarians and animal producers may buy drugs in anticipation of their use, but never actually administer them to animals, or they may use them later. clarified the CVM.
US and Europe – a divergent political approach
Prolonged use of low-dose antibiotics in healthy animal feed creates ideal conditions for antibiotic-resistant strains of bacteria to grow, multiply and spread through the human population, the Defense Council said. Natural Resources (NRDC) in a statement. new information note. “In fact, the science It has long been clear that antibiotic resistant bacteria spread from farm animals to human populations, including directly via farmers and other workers handling these animals and indirectly via water, soil and air contaminated with bacteria as well as contaminated meat.said the US-based nonprofit environmental advocacy group.
The NRDC brief argues that the United States and Europe have taken divergent policy approaches to combat the spread of dangerous antibiotic-resistant bacteria, in particular to track and reduce antibiotic use in animal production.
“Over a decade, Europe’s explicit approach was to improve animal health and prevent disease by changing conditions and practices on farms, thereby avoiding the need for antibiotics. This approach coincides with the fact that almost all of the largest European livestock farmers reduce their intensity of antibiotic use by 50-60% between 2011 and 2020.
“European public health agencies, such as the European Medicines Agency (EMA), have played a crucial role in this reduction by creating systems that collect and report data on the sales and use of veterinary antibiotics. These data are essential for tracking antibiotic use rates and progress towards better antibiotic management. US policy makers should learn from Europe’s experience and successes in public health.
Usage reduction targets
The nonprofit group said it has long advocated three policies, modeled after those in Europe, that Congress or the FDA could implement without further delay.
One is about setting ambitious usage reduction targets. “The FDA should set a goal of reducing antibiotic use in livestock by 50 percent by 2025, compared to a 2010 baseline.”
The agency must also closely monitor the use of antibiotics in animal production, advocates said. “Rigorous monitoring of antibiotic use is essential to measure improvements in responsible antibiotic stewardship and progress towards national reduction targets. The public health need to rigorously track antibiotic use, particularly at the farm level, has been recognized in the United States for decades, but has never been acted upon. This should be fixed immediately. At the same time, the FDA should take immediate steps to estimate annual antibiotic use in all food-producing animals since 2009 based on weight-adjusted national sales. This approach is endorsed by the World Organization for Animal Health. Our analysis already provides this weighted sales data. Ideally, however, the FDA would make its own weight adjustments, reporting them each December with its annual sales summaries. Ultimately, public health goals will be better served if the United States joins other countries in reporting domestic sales and/or using data using measures that enable rather than obscure comparisons between countries or regions.
Additionally, the United States should end the use of antibiotics in healthy animals for disease prevention, the NRDC added. Some of Europe’s major livestock-producing countries have found that an essential step in curbing the overuse of antibiotics is to end their use in healthy animals for so-called preventive purposes. Since January 2022, these avoidable uses of antibiotics have become illegal throughout the EU, with a few exceptions. The new law is also in line with 2017 guidelines published by the World Health Organization (WHO).
Campaigners argue that the evidence from Europe, to date, backed by published scientific reviews commissioned by the WHO, underscores that the use of preventative antibiotics is not necessary for animal health. In fact, it can be prevented through improvements in farming and animal husbandry practices that help prevent disease from occurring in the first place, the organization said.
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