Pew calls for antibiotic label refinements

Pew said in its 12-page report that it had reviewed the labels of all currently approved medically important antibiotics for food animals.

The Pew Charitable Trusts issued a report Oct. 4 criticizing the Food & Drug Administration and the animal health industry for some antibiotic drug product labels that it says are not consistent with judicious use principles as established under FDA policy.

Pew said in its 12-page report that it had reviewed the labels of all currently approved medically important antibiotics for food animals in the U.S. and found that nearly 30% of the labels investigated didn’t limit the duration of use and 25% didn’t give dosages that took into account the animal’s weight.

In total, Pew researchers reviewed 389 labels for medically important antibiotics given to animals and found 140 that didn’t follow FDA’s judicious use standards.

FDA’s Guidance for Industry #213—a policy designed to ensure the judicious use of antibiotics that are medically important to humans in the production of food animals—will take effect Jan. 1, 2017. The guidance, which was published in December 2013, asks animal drug companies to make two changes for antibiotics shared by humans and animals: remove indications for promoting growth from the labels of antibiotic products and require veterinarians to oversee the addition of these drugs to feed and water for any reason.

Although Guidance #213 is voluntary, animal drug companies have agreed to comply, and producers and veterinarians will have to follow the revised labels. Once implemented, the policy will change the way medically important antibiotics are used on farms.

“Animal agriculture – including farmers, veterinarians, feed mills and animal health companies – is currently working to implement significant changes in the way antibiotics are used to keep food animals healthy. These changes build on animal agriculture’s decades-long history of innovation and continuous improvement undertaken to ensure antibiotic stewardship, including the design of modern production systems, which have helped reduce the need for many antibiotics. Under a new FDA policy, which goes into effect Jan. 1, 2017, antibiotics similar to those used in human medicine will be used in food animals only to fight disease under the supervision of a veterinarian,” said the Animal Ag Alliance in response to the Pew report.

“This regulatory change proactively addresses issues raised in the Pew report by ensuring that a licensed veterinarian must order and oversee the use of a medically important antibiotic administered through feed or water. All remaining legally approved uses of these antibiotics will be therapeutic, targeted, uses – meaning only for the prevention, control or treatment of disease. The FDA-approved label for each product – which must be followed exactly by both veterinarians and farmers — designates a specific disease or pathogen to be targeted when the product is used therapeutically.

“The farm’s veterinarian will be charged with deciding if that specific disease or pathogen is present and threatens the health of the animal or group of animals. The duration of use should be dictated by the disease threat; we cannot tie the hands of veterinarians by removing their ability to make medical decisions appropriate to all situations. Treating and preventing disease is critical to both human and animal health, and it is inhumane and unethical to ask farmers and veterinarians to allow animals to suffer when it is clear disease threats exist and could be managed with the responsible preventative use of antibiotics,” said Animal Ag Alliance.

FDA has indicated that it's already considering a proposal that would discourage the open-ended use of certain antibiotics on farms. In a Federal Register notice published Sept. 13, the agency asked for comments on whether to limit certain drugs not covered by existing guidance.

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