After more than a year in the making, the US Food and Drug Administration issued a final rule that will require drug makers to report the amount of antibiotics that are sold for use in different types of food-producing livestock.
By collecting this data, the agency hopes to better understand exactly how the medicines are used by farms that raise hogs, cattle, chickens, or turkeys for human consumption. The rule goes into effect in 60 days, according to a notice published today in the Federal Register.
The FDA was urged by consumer groups and lawmakers to take this step over concerns about antibiotic resistance, which has been blamed for some 2 million illnesses and 23,000 deaths in the United States, according to the Centers for Disease Control and Prevention. About 70 percent of antibiotics used to treat Americans are also used in livestock, according to the Natural Resources Defense Council.
The issue centers on the extent to which antibiotics are given to food-producing livestock for preventing disease or promoting weight gain. Fattening livestock makes animals better suited for increased food production. But this tactic can also encourage unnecessary antibiotic use, which can be difficult to parse, since many antibiotics are approved for both promoting growth and preventing disease.
“If you can look at sales data by species, you can see what food producers are doing with antibiotics,” said Gail Hansen, a public health consultant who specializes in antibiotic resistance and infectious disease. “This isn’t a perfect plan, because sales data doesn’t exactly correlate with antibiotic use, but it can provide useful insight into trends.”
Until now, the FDA has not had access to specific information showing how antibiotics are used by food producers. An annual report issued by the agency tracks only total usage of different types of antibiotics in food-producing livestock. The latest report found a 4 percent gain from 2013 to 2014, and a 22 percent increase between 2009 and 2014 (see page 40). These figures only represent domestic use.
Meanwhile, the amount of antibiotics consumed by food-producing animals in the United States is expected to rise by about 20 percent between 2010 and 2030, according to a study published last year in the Proceedings of the National Academy of Sciences.
“This information will further enhance FDA’s ongoing activities related to slowing the development of antimicrobial resistance to help ensure that safe and effective antimicrobial new animal drugs will remain available for use in human and animal medicine,” said Dr. William Flynn, deputy director for science policy in the FDA’s Center for Veterinary Medicine, in a statement.
But an industry trade group wants the FDA to reconsider. The Animal Health Institute, which represents drug makers, said the companies are “disappointed… We believe this rule will result in an inaccurate representation of the data that will be misleading and not contribute to sound decision making.” The trade group already collects and publishes sales data, and supports funding for a US Department of Agriculture effort to collect such information.
Before the FDA released a draft version of the rules last year, the agency had been criticized for a voluntary plan to curb antibiotic use. The plan, which goes into effect later this year, requires drug makers to commit to remove any mention of antibiotics for promoting animal growth from their product labeling. The Animal Health Institute has said its members would comply with the rule.
Two years ago, several Democratic US senators had written the FDA over concerns the voluntary plan would do nothing to make it possible for agency to determine the extent to which improper use actually declines. That move was vigorously supported by several consumer groups, one of which expressed disappointment with the final FDA rule.
“While industry estimates of sales by species are better than nothing, they fall far short of what is needed to adequately monitor FDA’s efforts to combat antibiotic resistance” said Steve Roach, Food Safety Program Manager for Food Animal Concerns Trust and a spokesman for Keep Antibiotics Working, in a statement.
He argued the FDA effort will be “highly limited,” because data will come only from drug makers, which may not be aware of how antibiotics are used. The agency, he explained, will supplement its data with the Department of Agriculture surveys of farms, but he contended these have flaws because they do not collect data on the amounts of antibiotics used for all major food animal species.
Roach also noted that Congress has not provided sufficient funding for data collection, which may impede the ability of the FDA to successfully collect and interpret sales data during the initial stages of the effort.
“We’ve been waiting on this for years, and it’s disappointing that these changes to collect species-specific use of antibiotics are only being made as a result of growing public pressure,” said Congresswoman Louise Slaughter, a New York Democrat, in a statement. She also vowed to “push the FDA to quickly expand its efforts to on-farm surveillance so that new antibiotics remain effective and don’t go the way of current drugs.”