3 big animal drugmakers volunteer to change labels

Three of the largest U.S. makers of animal medications have agreed to change labeling of their antibiotics to remove uses for growth and production as the FDA continues efforts to fight super-resistant foodborne pathogens.

Eli Lilly ($LLY), Merck ($MRK) and Pfizer ($PFE), which has its animal health unit up for sale, are voluntarily making the changes to their FDA-approved labels, Michael Taylor, deputy commissioner for foods at the FDA, told Bloomberg.

Under new proposed guidelines, farmers and production agriculture companies will now need to get a veterinarian's prescription for all antibiotics to help ensure they are being used for medical uses and not for weight gain. Once they have them, however, they are not prevented from using them for off-label purposes. 

As the widespread use of antibiotics for production has grown, there has been an increase in pathogens that doctors can no longer treat using standard antibiotics. About 20,000 people have been sickened and 26 have died from these so-called "super bugs" because doctors could not find antibiotics that would quell them, Bloomberg reports.

The agency said it expects to issue final guidance on animal antibiotics at the end of the year and that it should take about three years for drug manufacturers to make the label changes. The FDA believes the voluntary approach can get faster results than mandating label changes but critics have raised doubts about the industry policing itself.

The FDA had put some limited restrictions on antibiotic use in animals in January but a federal judge last month ordered the FDA to follow through on a pledge to limit antibiotic use in livestock.

- read the Bloomberg story

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