FDA will strengthen controls over antibiotics in livestock, says Gottlieb

In the first days of 2017, the FDA instituted long-sought controls over farm use of antibiotics, with a ban on use of medically important antibiotics as a growth promoter in cattle, hogs and poultry. FDA commissioner Scott Gottlieb says the next two steps in promoting antimicrobial stewardship will be veterinary oversight of antibiotics injected into food-bearing animals and the setting of time limits on how long medically important antibiotics can be used in water supplies and feed rations for livestock.

The changes are part of the government’s efforts to preserve the efficacy of antibiotics in fighting disease and infections in humans. The CDC estimates at least 2 million Americans a year develop serious infections caused by antibiotic-resistant pathogens and at least 23,000 of them die as a result.

A pair of FDA “guidance” documents issued early this decade to drugmakers led to the ban on use of antibiotics to help livestock gain weight and required veterinarians to prescribe and oversee the use of medically important antibiotics for prevention or treatment of disease in food animals.

“And because of this work, about 95 percent of the total quantity of medically important antimicrobials sold or distributed for use in food-producing animals are now under veterinary oversight. This is significant public health progress,” said Gottlieb at Pew Charitable Trusts on Friday.

“One area of focus that we’re announcing today is our intention to work with the industry to bring the remaining 5 percent of medically important antimicrobials approved for use in animals, such as certain injectable antimicrobials, under veterinary oversight,” said Gottlieb. The FDA plans to release a draft strategy, probably in the form of a guidance document, by the Sept 30 end of fiscal 2019, “to assist industry in making needed changes.”

At least 40 percent of medically important antibiotics approved for use in livestock water and feed can be used for unlimited time for at least one “indication,” said Gottlieb. “That’s why the FDA is announcing today our plans to develop and implement a strategy to address this issue.” A guidance document on those medications will be issued by the end of fiscal 2020. “We recognized that stakeholder feedback will be crucial in finding a workable solution.

Guidance documents do not carry as much weight as an FDA regulation but are a strong indication to industry of the behavior the government expects. They do not take as long to produce as a formal regulation.

Livestock account for the majority of antibiotic consumption in the United States – as high as 80 percent by some estimates.

Gottlieb said FDA plans to enhance the National Antimicrobial Resistance Monitoring System. “We’re also working to further refine industry reporting of antimicrobial sales data. And we’re seeking to gain a better understanding of how these products are actually used on farms. This includes continuing to fund several pilot projects to help us better understand on-farm use. We plan to publish reports of this work,” he said.

Also on Friday, the FDA released its five-year plan to help veterinarians combat antibiotic resistance in the livestock industry.

In late 2017, the FDA said sale of antibiotics for livestock used had dropped by 10 percent in 2016 after seven years of increases since it began keeping records of the data. The 2016 data were the first to show sales for the major types of food animals 43 percent of sales were for cattle, 37 percent were for hogs, 9 percent for turkeys, 6 percent for chickens, and 4 percent for other species or unknown uses.

To read Gottlieb’s remarks at Pew, click here.

To read the five-year plan, click here.

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