A year after the U.S. Food and Drug Administration released its Guidance for Industry #213, analysis by the Pew Charitable Trusts finds that gaps in the animal antibiotics policy could allow for some drugs to be used at the same rate.
In order to reduce antibiotic misuse and address the increase in antibiotic-resistant bacteria, FDA released Guidance #213 asking drug makers to remove indications for “feed efficiency” and “weight gain” from antibiotics labels and requiring veterinarians to oversee any addition of antibiotics to feed and water.
The agency released the policy in December 2013 and it’s expected to be fully implemented by the end of 2016.
For their report released Wednesday, Pew reviewed labels of the 287 antibiotic products affected by Guidance #213. They compared the dosage for “growth promotion” and “disease prevention” approved for each drug.
Half had no overlapping dosages. Of the labels with overlapping growth-promotion and disease-prevention dosages, 66 of them can be used in at least one species of livestock (chickens, turkeys, pigs, or cattle) for disease prevention at the same levels as the promotion doses and without a limit on duration.
FDA classifies 29 of these 66 antibiotics as critically important in human medicine and 37 as highly important.
There were 13 additional labels with overlapping dosages but with duration limits, and four that only partially overlapped.
The analysis gives weight to concerns voiced by public health advocates over the past year that, while drug companies comply with the guidance, farmers could still give their animals certain antibiotics at the same rate but call it “disease prevention” instead of “growth promotion.”
“We are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease,” said Gail Hansen, a senior officer with Pew’s human health and industrial farming project.
Laura Rogers, director of Pew’s campaign on human health and industrial farming, emphasized that many producers are serious about reducing antibiotic overuse and that “our analysis isn’t focused on what companies will or won’t do, we’re focused on the policy, and we’re concerned about the gaps we find on that side.”
But the Animal Health Institute (AHI), which represents the veterinary pharmaceutical industry, argued that the Pew report is wrong.
“There is no loophole,” the organization said in a statement. “Of those approved applications with growth promotion claims, only 17 also have prevention claims on their product labels, and in none of those 17 instances are the dose and duration of use the same for the growth claim and prevention claim.”
Disease prevention is important for both human and veterinary medicine, AHI said, and approved disease prevention claims are “targeted … and veterinarians can only specify their use when there is evidence for the disease or bacterium.”
In its report, Pew recommends that FDA take additional steps for detailed monitoring of antibiotic use, establish a target for reduction of use, and develop a process and timeline for reviewing the adequacy of disease-prevention label claims.
“FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances,” Hansen said.