Source: MEATINGPLACE, 10/6/16

The Pew Charitable Trusts said nearly one-third of labels for medically important antibiotics for food animals will not meet the Food and Drug Administration’s standards for judicious use even after the agency’s new guidelines are adopted.

The organization said its analysis found that more than 140 of 389 labels for medically important antibiotics are potentially problematic, while the remainder defines conditions for use in a manner consistent with judicious use standards. About three-quarters of the potentially problematic labels are for brand name or patented drugs.

FDA should announce a concrete plan and timeline for making all necessary label revision changes as quickly as possible, the organization said in its report.

“The focus should be not only on duration limits but also on all aspects of judicious use, including specifying clear dosages and revising questionable indications,” Pew said.

FDA’s new guidelines were published in December 2013 and will take effect Jan. 1, 2017. The guidance 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 the guidance is voluntary, animal drug companies already have agreed to comply.

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