WASHINGTON, Dec. 11, 2013 – FDA today released a long-awaited guidance limiting the use of on-farm antibiotics to slow the spread of antimicrobial resistance in humans. And it appears that agriculture, for the most part, is happy with the result.

The Animal Health Institute, which represents a number of animal drug companies, said in a statement it supported the policy and pledged to “continue to work with FDA on its implementation.”

On a media call, representatives from the National Pork Producers Council (NPPC) and the American Veterinary Medical Association (AVMA) said they had worked with the regulatory agency to determine the scope of the guidelines and indicated they were pleased with the results.

“We don’t really foresee any bumps in the road in terms of our membership,” said AVMA’s Dr. Christine Hoang.

The National Chicken Council in a statement gave special recognition to FDA, which the group said had undertaken an “open and collaborative process…to phase out of the use of subtherapeutic…uses of antibiotics that are medically important in treating humans.”

Zoetis, the large animal health company, said it planned to comply with the guidance, which is non-binding.

Lack of data, however, means industry is currently unable to gauge the cost of the guidance to their producers. Discontinuing the use of subtherapeutic level of antibiotics means some producers will have to feed their livestock more grain to get them up to market weight, and could lead to slightly elevated levels of disease, said Liz Wagstrom, a veterinarian with NPPC. This will mean increased costs for the livestock industry.

The FDA announcement comes about a year a half after the agency released two proposed guidances on antibiotic use in livestock, both of which were finalized by today’s action.

“We need to be selective about the drugs we use in animals and when we use them,” said William Flynn, deputy director for science policy at FDA’s Center for Veterinary Medicine. “Antimicrobial resistance may not be completely preventable, but we need to do what we can to slow it down.”

Guidance #209 establishes two voluntary guidelines: that medically important antimicrobial drugs in food-producing animal should only be used when necessary to promote public health; and that the drugs in animals should only be used under the supervision of veterinarians.

Guidance #213 phases out the use antimicrobials for growth promotion – a practice that has received criticism from a number of food safety advocacy and watchdog groups. The guidance instructs drug companies to change “feed products containing medically important microbial drugs” from Over-the-Counter regulation status to prescription, or Veterinary Feed Directive (VFD), status.

Finally, a proposed Veterinary Feed Directive released today would require veterinarians to make on-site visits and write more detailed reports on animal operations.

Though the guidance is voluntary, Richard Carnevale, Animal Health Institute’s vice president of scientific, regulatory and international affairs, said the FDA would take steps against animal drug companies that do not comply with the guidelines.

“If the FDA does not get voluntary action within the timeframe they’d like to see it, they will use regulatory authority,” he said.

Companies have three months to tell FDA whether they will comply with the guidance, and then three years to implement the changes.

But not all are pleased with today’s release. Perennial on-farm antibiotics critic Rep. Louise Slaughter, D-N.Y., said the voluntary guidance “is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.”

Slaughter’s Preservation of Antibiotics for Medical Treatment Act (PAMTA), which has been introduced in the House twice but never passed, would create mandatory regulations restricting eight classes of antibiotic to humans and sick animals.

FDA indicated, however, that it chose a voluntary approach because it was the speediest regulatory option and may ultimately produce the same results as a mandatory regulation.

Consumer groups also indicated they were dissatisfied with FDA’s action. Jean Halloran, Consumer Union’s director of food policy initiatives, called the guidance “a good first step,” but said “much more needs to be done to address disease prevention” by tracking antibiotic use.

Of issue for many of those advocating for limited antibiotics use is the dearth of data on the subject. Slaughter says 80 percent of the antibiotics used in the U.S. are for livestock, though that number is disputed by industry.

Producers also point out that many antibiotics used in animal husbandry are not used to treat humans. FDA data show that about a third of the antibiotics sold for livestock in 2011 are in a class never used in human medicine. Expert say that while sales data do not accurately reflect antimicrobial drug use, the figures indicate a reduced threat that resistance to antibiotics could jump from animal to human populations.


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