Industry fighting expanded antibiotics reporting
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WASHINGTON, Aug. 19, 2015 - The Food and Drug Administration's plan to require reporting on animal antibiotic sales species by species is running into strong industry opposition.
Drugmakers now only report total sales for individual drugs. Breaking the sales data down by cattle, hogs, chickens and turkeys would help the government track how the drugs are being used and more easily target its actions to curb the spread of antibiotic-resistant bacteria, the FDA says.
In comments filed with FDA, industry groups say the data would be difficult to produce, misleading and would likely be used unfairly to target segments of the industry. They also objected to an agency proposal to allow the use of estimates when firm data is not available.
“Producers and veterinarians should not become 'targets' as a result of the release of information by FDA,” said the Animal Health Institute, which represents drugmakers. The group cited an article in which a food policy advocate is quoted as saying that the data would aid in knowing “where to apply pressure to the food industry.”
A leading manufacturer, Zoetis, said that once a product is sold it is difficult for companies to know how it is actually used. The American Feed Industry Association is challenging FDA's authority to even require species-specific data. The group says the 2008 law that mandated the reporting is clear on companies are supposed to include, and specific-specific sales data are not on the list.
The FDA proposal, released in May, is part of a broader Obama administration strategy to combat antibiotic resistance. The agency said that more actions will be proposed. While the species-specific data would provide a “fuller picture” of antibiotic use in livestock and poultry, “more detailed information is needed about on-farm use practices to adequately understand links between usage patterns and trends in resistance,” the agency said.
The deadline for comments on the plan was Tuesday.
Critics of farm usage of antibiotics praised the proposal, saying it would help scientists understand how antibiotic resistance develops, a point that the Government Accountability Office made in a 2011 report. However, that same GAO report quoted FDA officials as raising concerns about requiring species-by-species reporting, including that companies don't necessarily know how much of the drugs are used for which animals.
The Pew Charitable Trusts, which backs the FDA proposal, said the data would likely reveal shifts in antibiotic usage, noting that several major poultry producers have stopping using the antibiotics routinely.
The group said that even with the species-specific data it still wouldn't be clear how much of the drugs are being used for which purpose - growth promotion versus disease prevention or treatment.
The American Veterinary Medical Association, which is headed by Ron DeHaven, a former top official in the Agriculture Department, cautioned FDA that while the species-specific data would help in analyzing sales trends and the possible connection to antimicrobial resistance development, the data shouldn't be used alone.
“Use of sales data to estimate antimicrobial use has been shown to be extremely inaccurate, with the potential for serious misinterpretation,” DeHaven wrote in comments on the proposal.
The National Cattlemen's Beef Association told FDA that drugmakers would have to use “best guess ‘estimates'” of species usage in nearly all cases and that the estimates shouldn't be used in analyzing trends.
NCBA also said that reporting on use by cattle wouldn't distinguish between dairy cattle and beef cattle or between calves and feedlot animals, or between lactating and dry cows. “The different production classes within a species may all receive different amounts of antimicrobial drugs for a number of specific purposes,” NCBA said.
The FDA's latest annual report on antibiotic sales, issued in April, said that usage of medically important antibiotics in food animals rose 3 percent from 2012 through 2013. The year-over-year increase meant that sales of the drugs rose 20 percent from 2009 to 2013.
FDA is working with pharmaceutical makers to reduce the usage of the drugs on farm as part of a broader government-wide strategy to curb the spread of antibiotic resistant bacteria. Drug manufacturers have voluntarily agreed to phase out sales of medically important antibiotics for growth promotion in food animals. FDA, USDA, and the Centers for Disease Control and Prevention will be holding a public meeting Sept. 30 on possible approaches to collecting data on on-farm usage of antibiotics.