January 23, 2018

PEW Criticizes Gaps in FDA’s Antibiotic Policy

PEW Charitable Trusts is criticizing the U.S. Food and Drug Administration’s policy on antibiotic use in food animals, saying there are gaps in the law that promote the growth of antibiotic resistant bacteria. The organization wants the FDA to remove indications for “feed efficiency” and “weight gain” from the labels of animal antibiotics and require vets to oversee the use of the drugs.

FDAFDA issued a new policy on antibiotic use in farm animals called Guidance for Industry #213 that was intended to reduce antibiotic misuse. They removed the use of sub-therapeutic additions of antibiotics for feed efficiency and weight gain, but kept the use for disease prevention.

PEW reviewed labels of all of the 287 antibiotic products identified by #213 and looked for overlap in the areas of growth promotion and disease prevention. They found that many antibiotics approved for disease prevention were also approved for growth promotion. It turns out that 66 of the 287 drugs used in at least one species of animal for disease prevention are well within the range of growth promotion doses, so #213 will not accomplish much.

More troubling, 29 of these 66 antibiotics are critically important to human medicine. The language in #213 is ambiguous enough so drug makers and farmers can use these loopholes on the product labels to continue to give antibiotics to these animals.

Veterinarian Dr. Gail Hansen, senior officer with the PEW Charitable Trust said in a statement, “even if Guidance #213 is fully implemented, we are concerned that dozens of products could still be added to animal feed or water throughout the animals’ lives in the absence of any threat from a specific bacterial disease. FDA’s policy is an important step, but there is more work to do, both to effectively eliminate growth promotion and to ensure that antibiotics are prescribed by veterinarians to prevent disease only under well-defined circumstances.”

PEW wants the FDA to establish a clear target for reduction of total antibiotic use in food animals. They also want to see a detailed plan and timeline for monitoring and publicly reporting antibiotics use in food animals, and a process and timeline for reviewing adequacy of disease prevention label claims.

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