FDA rule would expand data reporting regs for animal antibiotics

The Food and Drug Administration (FDA) proposed a new rule Tuesday that would require animal drug manufacturers to track how much of their antibiotics sold are for chicken, cattle, pigs, turkeys and other food-producing animals.

The rule aims to combat antibiotic resistant bacteria that can form in animals and be transferred to humans. Though the Animal Drug User Fee Amendments  (ADUFA) of 2008 requires animal drug manufacturers to report annual sales, they are not currently required to submit sales or distribution data by particular species.

The rule would make reporting by species a requirement and improve the timeliness of reports by forcing the FDA to publish its annual summary report of antimicrobial sales and distribution by Dec. 31 of the following year.


Though nearly a decade late, advocates say any effort to close the information gap is welcome.

“Had leadership acted sooner, we’d already be collecting species-level data by now, which is essential to help us measure the success of FDA’s voluntary guidance to industry,” Susan Vaughn Grooters, policy analyst for Keep Antibiotics Working, said in a news release.

In response to FDA’s proposed rule, on which the public has 90 comment, Rep. Louise Slaughter (D-N.Y.) reintroduced a bill to give the public better information on how antibiotics are being used in animals raised for human consumption. 

The Delivering Antimicrobial Transparency in Animals or DATA Act would codify FDA’s reporting rule for antibiotic use by species and force drug manufacturers to report the reasons why the drugs are being used. 

 Slaughter said 80 percent of antibiotics in the U.S. are used on healthy farm animals

"Knowing how much of the drugs are being used in cattle or pork or poultry will be helpful in identifying the problem areas, but it won’t change the fact that we are frittering away one of our most precious resources for human health,” she said in a news release. “I will continue to call on the FDA to make all the changes necessary to meet their mandate of protecting the public health."

FDA said more information is needed about on-farm use practices to adequately understand links between the patterns of antibiotic usage and antibiotic resistant bacteria.