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US agency seeks voluntary restrictions on animal antibiotics

Spurred by long-running concerns about the rise of resistant strains of microbes, the US Food and Drug Administration (FDA) announced on 11 April a multi-pronged initiative to cut back on the use of antibiotics in US farm animals — but, because the measures are voluntary, sceptics say the initiative lacks the punch of robust regulation.

Farm animals receive an estimated 70% of all antimicrobials administered in the United States, but the drugs are often used in ways that go beyond ordinary infection risk. For example, antibiotics are often mixed into feed to help the animals’ growth and digestion and to improve disease resistance. The FDA first acknowledged that such ‘overuse’ contributes significantly to drug resistance in bacteria and other microbes in 1977, but since then, antibiotic use has increased steadily, with little regulatory action.

“We know that the widespread use of antibiotics can contribute to antimicrobial resistance, which has public-health consequences,” Michael Taylor, the FDA deputy commissioner for foods, told reporters at a telephone news briefing. “This guidance establishes a strategic framework for phasing out growth and production uses and phasing in veterinary consultation and oversight.”

The FDA’s initiative amounts to three “guidance” documents for farmers and animal producers, pharmaceutical companies and veterinarians. Under these guidelines, producers of livestock and poultry will use only certain antibiotics for therapeutic purposes, and pharmaceutical companies will remove growth and production uses from those drug labels. The guidelines also call on independent veterinarians to step in as watchdogs to ensure that the right drugs are used “judiciously” and “efficiently” to treat and prevent diseases.

Taylor said the FDA wants to accomplish all of the above in three years.

Critics see the measure as an ineffective response, because the initiative is a voluntary effort instead of a formal ban. “These are still just recommendations,” says Avinash Kar, a San Francisco, California-based attorney with the Natural Resource Defense Council, an environmental advocacy group. “This does not require the industry to do anything.”

The FDA says that they went with a voluntary effort to save time and money. “With the willingness of drug companies and others in the animal-production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely on a cumbersome regulatory process, which could take decades and millions of dollars,” said Taylor.

Implementation may prove problematic in rural areas with few local vets. “We know that change will be more challenging for small-scale and geographically remote animal producers, and we won’t forget about the special needs of those communities,” said Taylor.

But, even if drug companies go along with the initiative, it contains loopholes: many of the drugs in question are used for both growth and therapeutics, points out Richard Wood, chairman of the coalition Keep Antibiotics Working, so it’s unclear whether these guidelines will produce a significant reduction in their use. Wood is also concerned with how the guidelines address new uses for antibiotics and wonders whether the process may take longer if companies don’t cooperate to meet the FDA’s three-year goal.

“Their process will take three years to accomplish if everybody cooperates, and then after three years they may have to go after the violators probably one by one,” says Wood. “The FDA is wagging a regulatory stick but who knows how effective that will be.”

The announcement comes on the  heels of new FDA rules restricting the use of two antibiotic drugs in the cephalosporin family, which went into effect last week.  Meanwhile, on 23 March a federal court ordered the FDA to do something to reduce the use of tetracycline and penicillin in farm animals.


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