FDA changes stance on antibiotic use in food-producing animals

WASHINGTON — Livestock farmers are facing some major changes in the way they use antibiotics after the U.S. Food and Drug Administration announced the eventual elimination of antimicrobials in food animals.

The FDA issued new plans Dec. 11 to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as enhancing growth or improve feed efficiency.

The plan will mean that all antibiotics administered to food-producing animals must be under the supervision of a veterinarian.

Certain antimicrobial medications have been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes such as using less food to gain weight. Some of these antimicrobials are drugs used to treat human infection, prompting concerns about the contribution of this practice to increasing bacteria and other microbes’ resistance to a drug. Once antimicrobial resistance occurs, a drug may no longer be as effective in treating infections.

The plan announced focuses on those antimicrobial drugs that are considered important for treating human infection and which are approved for use in feed and water of food animals.

Statistics released by FDA show that animal production uses more than 29 million pounds of antibiotics annually.

Road map

In a final guidance issued, the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications.

The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining therapeutic uses under veterinary oversight.

Once a manufacturer voluntarily makes these changes, its antimicrobial drugs deemed “medically important” can no longer be used for production purposes, and their use to treat, control, or prevent disease in animals will require veterinary oversight.

Once a product has gone through the recommended revision, it would be illegal for a producer to use it or a veterinarian to prescribe it for any use that is not on the label.

What does this mean?

FDA Spokesperson Siobhan DeLancey said a “guidance for industry” is not binding by law, but describes the agency’s current thinking on a topic.

The FDA is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. These companies would then have a three-year transition process.

DeLancey said once drug manufacturers have revised their product approvals to remove “production” indications and move any remaining therapeutic uses under veterinary oversight, farmers will have to work with their veterinarians to access these products for feed use, and they will have to limit their use to bona fide therapeutic uses.

“This action only applies to medically important antibiotics being used in feed or drinking water,” said DeLancey.

She added it doesn’t affect injectable drugs, nor does it affect non-medically important drugs (like ionophores or bambermycins), nor does it affect non-antibiotic production drugs (like beta agonists).

Two of the most prominent animal drug companies, Zoetis and Elanco, have already released statements indicating their full cooperation.

This approach does not rule out formal regulatory action on individual products if a company does not choose to cooperate.

Will it work?

DeLancey said the FDA works with USDA and CDC to track antimicrobial resistance in the food supply through the National Antimicrobial Resistance Monitoring System (NARMS), and FDA’s portion includes testing retail meat samples for resistant bacteria.

“We will be monitoring closely to see if there is a discernible effect on slowing the evolution of resistance, as anticipated,” said DeLancey.

Cattle producer

Frank Phelps, a cattle producer in Logan County, Ohio, said the changes will not impact his 250 head of Limousin cattle.

“I just don’t think its going to affect us that much. We work close with a veterinarian regarding all medication and we only use antibiotics for treatment and not prevention,” said Phelps.

Phelps said he thinks the FDA’s decision to change how antibiotics are used is a good idea. He added it is a good idea for veterinarians to handle dispensing antibiotics rather than others with no medical training trying to do it.

However, Phelps thinks consumers may be surprised to learn that producers don’t abuse antibiotics as much as they might think.

“That stuff is expensive and it hurts the bottom line,” said Phelps. “When they get sick, we have to treat them, but that’s where it ends.”

Confidence?

Meanwhile, one agency is not confident the change in antibiotic use will stop the spread of increasing antibiotic resistance.

Experts at the Johns Hopkins Center for a Livable Future, said that new FDA voluntary guidelines on antibiotic use are unlikely to reduce the use of the drugs in food animals or address increasing antibiotic resistance.

“The agency needs to change how antibiotics are used, but these guidelines will only change how they are labeled,” said Keeve Nachman, a scientist with the Johns Hopkins Bloomberg School of Public Health.

“Instead of issuing voluntary guidelines, the FDA should use its regulatory authority to protect public health by withdrawing all approvals to use antibiotics for disease prevention and growth promotion.”