Animal health groups offer mixed views on FDA antibiotic policy

Apr 18, 2012 (CIDRAP News) – Animal health groups today commended the Food and Drug Administration's (FDA's) voluntary approach to reducing the growth-promotion uses of antibiotics in farm animals but voiced some concern that the policy may hurt animal health and lead to higher meat prices.

Last week the FDA published three draft documents outlining how it proposes to phase out growth-promotion (production) uses because of the concern that they hasten the development of resistance in antibiotics for humans. The plan calls on drug companies to voluntarily remove production uses from their product labels.

The general aim of the FDA policy is to eventually end the agricultural use of antibiotics without veterinary supervision. The process is expected to take several years.

Industry and veterinary officials addressed the issue today at a press teleconference hosted by the Animal Health Institute (AHI), which represents companies that make veterinary drugs. They said they appreciate the collaborative approach the FDA has used in developing the policy, but they also evinced some worries about the impact.

By way of background, Ron Phillips, AHI's vice president for legislative and public affairs, said the FDA currently allows four types of label claims for antibiotics used in animals: treatment of disease, control of disease (for use in outbreaks), prevention of disease, and growth promotion or feed efficiency.

The FDA considers treatment, control, and prevention all to be "therapeutic" uses targeting a specific disease or agent, whereas growth promotion is what some call a "subtherapeutic" use, Phillips noted. He said producers and veterinarians are required to follow the label indications in all cases.

Liz Wagstrom, DVM, chief veterinarian for the National Pork Producers Council, voiced the most concern about the FDA's policy.

She said the experience in Denmark—which banned the production uses of antibiotics in pigs in 2000—and other countries has suggested that such uses yield health benefits for farm animals.

"We expect to see more sick animals and higher costs of production, which may or may not translate into higher prices in the meat case," Wagstrom said. "We expect those things without a positive impact to public health."

Richard Carnevale, DVM, the AHI's vice president of regulatory, scientific, and international affairs, agreed that the growth-promotion use of antibiotics improves animal health. "We have evidence that the use of these at lower levels . . . actually serves to prevent subclinical infections," he said.

Carnevale was asked if drug companies might change the label indications for some of the drugs now used for growth promotion to prevention, thereby permitting them to continue to be used much as they are now.

"That'll depend on if companies can conduct studies to show that," he said. He said growth-promotion claims have been used in many cases because they were relatively easy to prove. To change the label indication to prevention, drug makers will need to show the FDA not only that the drugs enhance growth, but that they do so by suppressing subclinical infections, he said.

When Carnevale was asked if simply changing label indications from growth promotion to prevention would undermine the FDA's effort to protect human health, he said, "If those indications are relabeled to preventive levels, then the FDA will have had to go through a process of determining their safety as well." The FDA "will have to certify that those things work, but that they'll also be safe."

In other comments, Wagstrom said the ban on production use of agricultural antibiotics in Denmark decreased the overall amount of antibiotics in animals but caused an increase in therapeutic uses, "often in classes of antibiotics considered more important or critical for human health."

Phillips, in an interview today, said Denmark saw a big drop in agricultural antibiotic use right after the ban, largely because a much greater proportion of overall use was for growth promotion than is true in the United States. "Over time, the amount they've used for treatment or therapy has more than doubled, so that total use is almost back to the same level as before the ban," he added.

He noted that detailed reports on animal antibiotic use in Denmark are available on a Danish government web site called DANMAP.

Also at the press conference, Carnevale estimated that medically important antibiotics make up roughly half of the total volume of antibiotics used in food animals.

Phillips, in the interview, said about 40% of the total volume of antibiotics used in animals are not used in humans and thus are not affected by the FDA proposal.

Also involved in the press conference was Christine Hoang, DVM, MPH, assistant director of scientific activities at the American Veterinary Medical Association, who said her group was "extremely grateful" to the FDA for reaching out to major stakeholders in developing its policy. She said the AVMA was not yet ready to offer official comments on the FDA documents.

See also:

Apr 11 CIDRAP News story "FDA spells out voluntary plan for cutting ag antibiotic use"

Animal Health Institute

DANMAP reports on ag antibiotic use in Denmark

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