U.S. FDA to phase out some animal antibiotics

(Reuters) — U.S. regulators have announced new guidelines that call on global pharmaceutical companies to phase out the use of some antibiotics meant to enhance growth in animals used for food.


The move hopes to stem a growing tide of bacterial resistance to the same drugs when they are prescribed for humans.


In guidance issued Dec. 11, the Food and Drug Administration asked global drug makers and animal health companies to voluntarily revise labels of medically important antibiotics to remove references to use in animal production.


“Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary,” the FDA said.


Critics said the voluntary guidelines give drug makers too much discretion in policing their own use of antibiotics. 


Democratic lawmaker Louise Slaughter called the FDA move an inadequate response to the overuse of antibiotics “with no mechanism for enforcement and no metric for success.”


Her view was echoed by consumer and environmental advocacy groups.


“Our fear … is that there will be no reduction in antibiotic use as companies will either ignore the plan altogether or simply switch from using antibiotics for routine growth promotion to using the same antibiotics for routine disease prevention,” said Steven Roach, senior analyst with advocacy group Keep Antibiotics Working.


The FDA said it had already re-ceived support for the new measures from Zoetis and Elanco, a unit of Eli Lilly that sells a large percentage of the products that will eventually be phased out. 


Elanco said it would voluntarily narrow use of antibiotics used to treat both humans and animals “only to therapeutic purposes of treating, controlling and preventing diseases in animals under the supervision of a veterinarian.”


It would become illegal for antibiotics to be used for agricultural production once companies remove it from drug labels, said deputy FDA commissioner Michael Taylor.


The program is meant to be voluntary, but Taylor said the FDA would be able to take regulatory action against companies that fail to comply.


The FDA’s “final guidance” also brings the drugs under oversight of veterinarians by changing their over-the-counter status.


The FDA said it will require animal pharmaceutical companies to notify the agency within three months of their intent to adopt its strategy. 


The companies would then have three years to complete the transition process. 


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