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FDA Moves to Curtail Agricultural Antibiotic Use

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The federal government is turning to the farm in an effort to combat the rise of antibiotic-resistant bacteria.

The Food and Drug Administration has asked animal pharmaceutical companies to remove indications allowing some antibiotics to be routinely used as growth promoters for food animals. If drug companies comply, these medications would be used only to prevent or treat disease in flocks and herds – a move the agency said would significantly reduce the development of antibiotic-resistant bacteria.

The completely voluntary recommendation gives companies 3 years to phase in the changes – plenty of time to allow for "an orderly and minimally disruptive transition," according to the document.

Only antibiotics deemed "medically important" to humans are covered under the recommendation. However, these include a wide variety of commonly prescribed medications.

© Scott Leigh/istockphoto.com

New recommendations on antibiotics for farm animals could limit the acceleration of antibiotic resistance, FDA officials said.

The recommendation requires that animal pharmaceutical manufactures notify the FDA within 3 months of their intent to comply. After 3 months, the FDA will publicly post a list of companies that don’t sign on to the process. If enough has not been done by the 3-year mark, the FDA may seek to legally ban the drugs’ use as growth promoters.

"If ... we determine that adequate progress has not been made, we will consider whether further action under the existing provisions of the Federal Food, Drug, and Cosmetics Act may be appropriate," the statement says.

The FDA also wants veterinarians to shoulder the responsibility for clinically responsible use of these antibiotics. Currently, many of the drugs are available over the counter.

The recommendation may be a fine first step, but it probably won’t be enough, according to Dr. Jeff Duchin, chief of communicable disease, epidemiology, and immunization at the Seattle and King County Public Health Department.

"It’s a potential step in the right direction," Dr. Duchin said in an interview. "We really think it’s the right idea but we are skeptical about the utility of a voluntary approach. It’s very important to make sure the FDA assesses this to see that it’s working, and moves aggressively to a regulatory approach if it doesn’t."

Such a federally mandated approach has been effective in several European countries, including Denmark, which banned the use of growth-promoting antibiotics in 1998. At the time of the ban, Denmark had one of the world’s lowest levels of animal antibiotic use, while the United States had the highest level (60 mg/kg of meat produced vs. 300 mg/kg).

After the Danish ban, bacterial resistance to each of the antibiotic classes and individual drugs included decreased among swine and chickens, according to data from a 2006 report by the World Health Organization. Some of these data also suggest a parallel effect in humans, although certain drug-resistant strains were already extremely low in human populations.

Research on the human impact continues, Dr. Duchin said. But although the data linking resistant strains in animals to those in humans are strong, it’s impossible to predict how long it would take for a change in animal husbandry to translate into human benefit.

"A matter of years, for sure," he said. "It’s not a rapid progress into the human population. But there is good reason to believe this type of policy would be useful in reducing human health risks."

Legislation has been introduced in Congress to control the use of animal antibiotics. H.R. 1150, the Preservation of Antibiotics for Medical Treatment Act of 2013, would amend the Federal Food, Drug, and Cosmetic Act "to preserve the effectiveness of medically important antimicrobials used in the treatment of human and animal diseases."

The law would prohibit the administration of a medically important antimicrobial to a food-producing animal except for medically necessary situations, and when given to the smallest possible number of animals in a group, for the shortest time clinically necessary.

Originally introduced in 2011, the bill failed to make it out of committee. It was reintroduced in March by Rep. Louise Slaughter (D-N.Y.) but has not been addressed since.

Dr. Duchin had no financial disclosures.

msullivan@frontlinemedcom.com

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