Source: Lisa M. Keefe, MEATINGPLACE, 5/19/15


The U.S. Food and Drug Administration has proposed a rule that would require animal drug sponsors of all antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales by major food-producing species — cattle, swine, chickens and turkeys — the federal agency said in a news release posted on its website.

The additional data would improve understanding of how antimicrobials are sold or distributed for use in major food-producing animals and help the FDA further target its efforts to make sure that medically important antimicrobials are used judiciously.
“Consistent with data collection objectives outlined in the ... National Strategy for Combating Antibiotic-Resistant Bacteria, this proposed rule is a step toward providing more detailed information to the FDA and the public on changes in antimicrobial sales and distribution over time,” said Michael R. Taylor, deputy commissioner for foods and veterinary medicine for the FDA. “We plan further actions to complete the task.”

Current regulatory authority limits the data collection that FDA can mandate to antimicrobial sales and distribution information. While adding species-specific information will help provide a fuller picture, more detailed information is needed about on-farm use practices to adequately understand links between use patterns and trends in resistance, the release said.

In a statement, the Washington, D.C.-based Animal Health Institute noted that animal health companies have been providing annual antibiotic sales data for food-producing animals to the Food and Drug Administration, and that the newly proposed regulation simply expands on those requirements.

"The Animal Health Institute has always supported the collection and use of data that has a stated, scientific purpose and helps producers and veterinarians use antibiotics more wisely. We will review and comment on the FDA proposal with those principles in mind," the statement said.

The FDA's species-specific data plans are a "next step" in the goal of sorting out how, or whether, the use of antibiotics in food-producing animals is related to the growing resistance of pathogens to antibiotic medicines that affects human health, says Gail Hansen, senior officer and public health veterinarian for the Pew Charitable Trust.

In an interview with Meatingplace, she said, "I don’t think there is one piece of data that’s going to give us all the information we need to know. This step probably goes as far as FDA can in what they can get from the sales data.

"It gets us another step, and when you mesh that with some of the data collected on antibiotic resistance and some of the data USDA has collected on farms where antibiotics are used, you start getting that picture coming together," Hansen said. "There’s not going to be a silver bullet piece of data."

The FDA is accepting public comments on the proposed regulation for 90 days from the date of publication of the notice of availability in the Federal Register. Electronic comments should be submitted to www.regulations.gov.

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