Manufacturers of antibiotics used in food-producing animals must now provide their estimated sales, by species, of the drugs they sell and distribute for that purpose, according to a final rule from the Food and Drug Administration.
Drugmakers are required to begin complying with the new reporting requirements when submitting their reports for this year.
But some advocates question whether the new requirement, which asks manufacturers to report only slightly more information than they do in their current overall estimates, is specific enough.
“This is a modest improvement ... but we need more and better data of on-farm use of antibiotics, including the purpose of use,” said Avinash Kar, an attorney with the Natural Resources Defense Council.
Experts say the widespread use of antibiotics in livestock has contributed to an increase in the number of antimicrobial-resistant pathogens over the past two decades.
An estimated 70% of medically important antibiotics are sold for food animals, according to the Pew Charitable Trusts. Some farmers include antibiotics in animal feed and drinking water to stave off infection, while others use it to boost weight.
The FDA began taking steps several years ago to curb non-medical use of antibiotics. In 2013, it issued guidelines requiring drug companies to voluntarily remove any animal-growth references from their labeling for medicines deemed medically important to humans.
But an advisory panel told the White House—which has launched a campaign to stop antimicrobial resistant diseases—that the FDA did not clearly define appropriate antibiotic use in food-producing animals.
Despite scrutiny on the issue, the FDA reported in 2014 that more than 16,000 tons of antibiotics approved for use in livestock were sold and distributed in the U.S. that year, a 22% increase since 2009.
Drugmakers urged the FDA to reconsider its final ruling.
In a statement, the trade organization Animal Health Institute expressed concern that the regulations would result in “inaccurate representation of the data that will be misleading and not contribute to sound decision-making.”
An estimated 2 million infections in the U.S. each year are related to antibiotic resistance, according to the Centers for Disease Control and Prevention, resulting in an estimated 23,000 deaths and $20 billion in annual healthcare expenditures.
