Animal health industry commits to FDA antibiotics guidance

By Sarah Gonzalez

© Copyright Agri-Pulse Communications, Inc.



WASHINGTON, March 12 2014 - The Animal Health Institute (AHI) and the Generic Animal Drug Alliance (GADA), the major representatives of the animal health industry, officially committed this week to FDA's newest voluntary guidelines on antibiotics use.

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AHI CEO Alexander Matthews said the guidelines, FDA's “Guidance 213”, would bring a “significant change in the way antibiotics are to be used in animal agriculture that we believe will avoid unintended consequences.”

Guidance 213, released last December, asks animal drug companies to voluntarily revise their product labeling. It requests companies to stop using antimicrobial drugs for growth promotion and directs them to change many drugs from “over the counter” to a status requiring veterinary oversight and consultation.

In a video accompanying an AHI statement, Richard Carnevale, vice president for regulatory, scientific and international affairs, said many companies and producers are already following FDA's recommendations.

 “Most of the antibiotics are used for treatment and control and prevention of disease, and very little [are] actually used strictly for growth promotion,” Carnevale said. AHI also says the FDA guidance directing veterinarians to use a more hands-on approach to prescribing antibiotics will also be redundant for many health care providers and producers.

Producers have “always had veterinarians,” Carnevale said. “Veterinarians do make the decisions. [The guidance] is just kind of essentially documenting what probably has been going on within the industry for many years.”

FDA suggests that animal health companies be given three years to implement the guidance. The agency must still issue a final rule on the proposed changes to the veterinary feed directive, which is used to ensure veterinarians oversee antibiotics use in feed.

AHI says the guidance should pacify public health officials, who have long argued that overuse of antibiotics in livestock rearing could build bacterial resistance and render the drugs ineffective, even for humans. But some livestock groups and their advocates say resistance won't make the jump to human populations.

According to analysis from veterinarian and former USDA Deputy Undersecretary for Food Safety Scott Hurd, 30 percent of the antibiotic varieties sold for use in livestock production are never used in human medicine, reducing the likelihood that animal antibiotic resistance can make the jump to human resistance.

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