Public health advocates concerned about how antibiotics used on farms impact increasing resistance, have long expressed the need for more on-the-ground data – particularly use by species. In May, the Food and Drug Administration proposed adding estimates of drug sales by animal species — cattle, swine, chickens or turkeys — to the summary of the information animal drug sponsors are required to report every year by the Animal Drug User Fee Act (ADUFA). The comment period for the proposed rule ended this week, and many groups support its finalization while also noting the need for on-farm use in addition to sales data. “While these data would not be precisely equivalent to on-farm usage data, they would nevertheless contribute to the overall understanding by FDA and other stakeholders of how these vitally important products are used,” state comments from The Pew Charitable Trusts. Such data would reflect changes made by poultry producers to shift away from routine antibiotics use and any changes due to implementation of FDA’s Guidance for Industry #213 and the Veterinary Feed Directive, according to Kathryn Talkington, director of Pew’s Antibiotic Resistance Project. But “still missing from current ADUFA data reports is a useful measure of the purpose of antimicrobial sales (i.e., growth promotion, disease treatment, control or prevention),” she added. Animal drug manufacturer Zoetis wrote that while it supports “the collection of useful data that will allow for the prudent and judicious use of medically important antimicrobial drugs in animals and people,” the proposed rule wouldn’t accomplish this goal and “should be withdrawn.” The company noted that distribution pathways are complex and once a drug is sold, it’s difficult to determine what animal it’s been given to. Sales and distribution data don’t take into account customer inventory either. “Sales and distribution data at a minimum greatly inflate any estimation of use and would introduce a major source of error into any estimation of final use for any particular year,” Zoetis wrote. Some other groups which came out in support of the rule included Center for Foodborne Illness Research & Prevention, Keep Antibiotics Working, the American Public Health Association, the Center for Science in the Public Interest, American Academy of Pediatrics, and the Humane Society of the United States. Also offered in support of the rule was a letter from more than 50 scientists who work on antibiotic resistance issues and a Pew-organized letter signed by more than 10,000 individual citizen advocates. It was announced on Thursday, Aug. 20, that FDA, in collaboration with the Department of Agriculture and the Centers for Disease Control and Prevention, will hold a public meeting on Sept. 30 to discuss possible approaches for collecting additional on-farm antimicrobial drug use and resistance data. “Listening to leading scientists and advocates will improve the FDA’s rule making,” said Rep. Louise Slaughter (D-NY) about the announcement. “I’m cautiously optimistic that this meeting will lead to collecting meaningful on-farm usage data and ultimately help to end the misuse of antibiotics that puts the public’s health at risk.” (To sign up for a free subscription to Food Safety News, click here.)
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