Regulatory Focus™ > News Articles > FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

FDA Guidance on Veterinary Antibiotic Use Prompts Compliance, Criticism

Posted 12 April 2012 | By Alexander Gaffney, RAC 

Shortly after the US Food and Drug Administration (FDA) released new rules to curtail the "injudicious" use of antibiotics in food-producing animals, three pharmaceutical manufacturers said they were agreeing to change the labeling on their veterinary antibiotics to exclude indications for food-producing animals, reports Bloomberg.

FDA Deputy Commissioner for Foods Michael Taylor said he has assurances from Pfizer Inc., Eli Lilly & Co. and Merck & Co.-three of the largest veterinary pharmaceutical manufacturers in the world-to voluntarily implement labeling changes, said Bloomberg.

FDA's voluntary guidances are in response to concerns that the over-use of antibiotics are causing drug-resistance in bacteria, negating the effectiveness of the antibiotics.

The guidance does not prevent veterinarians from using the antibiotics as they have before-something the National Cattlemen's Beef Association implied would continue to some extent-but does actively discourage its use, reports Bloomberg.

Consumer groups have said the guidance is a symbolic move that is destined to fail.

"This is an ineffective response to the real and sobering threat of rising antibiotic resistance, which threatens human health," said Avinash Kar of the Natural Resources Defense Council (NRDC), whose organization successfully sued FDA last month to force the agency to ban antibiotics in animal feed.

In a statement on NRDC's website, Kar further called the guidances an "empty gesture," saying they do not meet the standards for compliance set by the group's earlier court victory over FDA.

"Once again, FDA is pretending to act while barely acting at all," concluded Kar.

Read more:

Bloomberg - Superbug Rise Spurs Rule for Animal Antibiotics

NRDC - FDA Offers Make-Believe Solution to Antibiotic Resistance

Regulatory Focus - FDA Releases New Guidance To Voluntarily Limit Many Uses of Antibiotics in Animals

Regulatory Focus - Judge Orders FDA To Remove Antibiotics from Animal Feed

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