The Department of Health and Human Services (HHS) has increased veterinary oversight of antibiotics and, with the Department of Agriculture (USDA), has made several improvements in collecting data on antibiotic use in food animals and resistance in bacteria since the Government Accountability Office (GAO) last conducted an audit in 2011, but, GAO said in a new audit report, while HHS’s Food and Drug Administration (FDA) issued a regulation and guidance for industry recommending changes to drug labels, “oversight gaps still exist.”
HHS and USDA are primarily responsible for ensuring food safety, including safe use of antibiotics in food animals.
“For example,” GAO reported, “changes to drug labels do not address long-term and open-ended use of antibiotics for disease prevention because some antibiotics do not define duration of use on their labels.”
FDA officials told GAO they are “seeking public comments on establishing durations of use on labels, but FDA has not clearly defined objectives for closing this gap, which is inconsistent with federal internal control standards.” And, “Without doing so, FDA will not know whether it is ensuring judicious use of antibiotics.”
“Moreover,” GAO said it found, “gaps in farm-specific data on antibiotic use and resistance that GAO found in 2011 remain.”
GAO said it “continues to believe HHS and USDA need to implement a joint on-farm data collection plan as previously recommended. In addition, FDA and USDA’s Animal and Plant Health Inspection Service (APHIS) do not have metrics to assess the impact of actions they have taken, which is inconsistent with leading practices for performance measurement. Without metrics, FDA and APHIS cannot assess the effects of actions taken to manage the use of antibiotics.”
The World Health Organization (WHO) has stated that antibiotic resistance is one of the biggest threats to global health. The Centers for Disease Control and Prevention (CDC) has estimated that antibiotic-resistant bacteria cause at least 2 million human illnesses in the United States each year, and that there is strong evidence some resistance in bacteria is caused by antibiotic use in food animals (cattle, poultry and swine).
CDC has reported more than two million Americans a year are infected with bacteria resistant infections, resulting in 23,000 deaths annually. Those numbers could increase exponentially over the next several decades.
“The rise of antibiotic resistance is a global health crisis, and governments now recognize it as one of the greatest challenges for public health today. It is reaching dangerously high levels in all parts of the world,” Dr. Margaret Chan, WHO Director-General, said in 2015.
The threat of antibiotic-resistant infections is both imminent and deadly. WHO issued a report in 2014 warning that the world is on the cusp of a post-antibiotic era in which even common infections and illnesses can kill.
A WHO multi-country survey revealed people are confused about the rising threat of antibiotic resistance to public health and are unclear about how to prevent it from growing.
Only a quarter of the 133 countries that responded to a WHO survey have national plans to preserve antimicrobial medicines like antibiotics. The WHO report, Worldwide Country Situation Analysis: Response to Antimicrobial Resistance, which outlines the survey findings, revealed that while much activity is underway and many governments are committed to addressing the problem, there are major gaps in actions needed across all six WHO regions to prevent the misuse of antibiotics and reduce spread of antimicrobial resistance.
“This is the single greatest challenge in infectious diseases today,” said WHO Assistant Director-General for Health Security Dr. Keiji Fukuda. “All types of microbes—including many viruses and parasites—are becoming resistant to medicines. Of particularly urgent concern is the development of bacteria that are progressively lesstreatable by available antibiotics. This is happening in all parts of the world, so all countries must do their part to tackle this global threat.”
Issued a year after WHO’s first report on the extent of antimicrobial resistance globally, which warned of a "post-antibiotic era," the survey was the first to capture governments’ own assessments of their response to resistance to antimicrobial medicines used to treat conditions such as bloodstream infections, pneumonia, tuberculosis, malaria and HIV. It summarized current practices and structures aimed to address the issue, and shows there are significant areas for improvement.
“While there is a lot to be encouraged by, much more work needs to be done to combat one of the most serious global health threats of our time,” Fukuda said. “Scientists, medical practitioners and other authorities including WHO have been sounding the warning of the potentially catastrophic impact of ignoring antibiotic resistance. Today, we welcome what has been achieved so far, but much more needs to be done to avoid losing the ability to practice medicine and treat both common and serious illnesses.”
Homeland Security Today reported last year that a Department of Defense report confirmed the first case of a drug-resistant superbug in a person in the United States. The DOD researchers said the discovery “heralds the emergence of truly pan-drug resistant bacteria.”
Homeland Security Today also reported in 2008 that antibiotic resistant infections will be a serious problem during a large-scale pandemic.
According to the GAO’s latest report, it reviewed three selected countries and the European Union (EU) which have taken various actions to manage use of antibiotics in food animals, including strengthening oversight of veterinarians’ and producers’ use of antibiotics, collecting farm-specific data, and setting targets to reduce antibiotic use. The Netherlands has primarily relied on a public-private partnership, whereas Canada, Denmark and the EU have relied on government policies and regulations to strengthen oversight and collect farm-specific data. Since taking these actions, the use or sales of antibiotics in food animals decreased and data collection improved, according to foreign officials and data reports GAO reviewed.”
However, GAO disclosed, “some US federal officials and stakeholders believe that similar US actions are not feasible because of production differences and other factors.”
GAO reported, “HHS and USDA officials said they have not conducted on-farm investigations during foodborne illness outbreaks including those from antibiotic-resistant bacteria in animal products. In 2014, USDA agencies established a memorandum of understanding to assess the root cause of foodborne illness outbreaks. However, in 2015 in the agencies’ first use of the memorandum, there was no consensus among stakeholders on whether to conduct foodborne illness investigations on farms and the memorandum does not include a framework to make this determination, similar to a decision matrix used in other investigations. According to a directive issued by USDA’s Food Safety and Inspection Service, foodborne illness investigations shall include identifying contributing factors and recommending actions or new policies to prevent future occurrences. Developing a framework, in coordination with HHS’s CDC and other stakeholders, would help USDA identify factors that contribute to or cause foodborne illness outbreaks, including those from antibiotic-resistant bacteria in animal products.
GAO made six recommendations, including that HHS address oversightgaps, HHS and USDA develop metrics for assessing progress in achieving goals, and USDA develop a framework with HHS to decide when to conduct on-farm investigations.
USDA agreed with GAO’s recommendations, but HHS “neither agreed nor disagreed” with GAO’s recommendations.
