Issue Date: May 16, 2016 | Web Date: May 11, 2016
FDA requires antibiotics sales data by species
Drug manufacturers are now required to estimate how much of the antibiotics they sell in the U.S. are used on four major species of food-producing farm animals. Under a rule finalized last week by the Food & Drug Administration, drugmakers must report annual sales data for antibiotics administered to cows, pigs, chickens, and turkeys.
FDA intends to use the data to examine the link between use of antibiotics in farm animals and the rise of antibiotic-resistant bacteria. Animal drugmakers were previously required to report annual sales data for antibiotics to FDA, but that information was not broken down by species.
“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,” says William T. Flynn, deputy director for science policy in FDA’s Center for Veterinary Medicine.
The animal health industry opposes the new requirements, arguing that drugmakers do not have accurate information on the use of their products on farms. If a product is labeled for use on more than one kind of animal, any attempt to estimate how much is used on each species “will be nothing more than a guess,” the Animal Health Institute, an industry group, told FDA last year.
Environmental and public health groups sought the new reporting requirements, but they too are urging FDA to obtain actual data rather than estimates. “Collecting data on how antibiotics are used on farms, which is currently missing, is an important step,” says Avinash Kar, an attorney with the environmental group Natural Resources Defense Council. It and other organizations are calling for FDA to set national targets for reducing the use of antibiotics in livestock.
FDA says that it is working with the Department of Agriculture and the Centers for Disease Control & Prevention to collect on-farm antibiotic use and resistance data as part of the Obama Administration’s National Strategy for Combating Antibiotic-Resistant Bacteria.
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