The FDA said the steps are intended to reduce the development of antimicrobial resistance from the use of antibiotics used in both animals and humans. Under the plan, pharmaceutical companies will be asked to voluntarily revise the FDA-approved use conditions on labels to eliminate antibiotics in feed.

Another change will be the over-the-counter (OTC) status of the antibiotics in question. The FDA wants to bring the remaining appropriate therapeutic uses under the oversight of a licensed veterinarian.

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

Drug companies selling antibiotics have three months to notify the FDA whether they intend to follow the strategy. If they do, they will have a three-year transition process.

The Dec. 11 policy, labeled Guidance No. 213, establishes procedures for Guidance No. 209, which came out in April 2012, and phases out growth promotion indications for antibiotics used in animal feed and for human treatment.

To usher in veterinary oversight of antibiotics away from OTC usage, the FDA also issued a proposed rule to update regulations on Veterinary Feed Directive (VFD) drugs. These drugs require specific authorization by a vet using a process outlined in the agency’s VFD regulations.

“This action promotes the judicious use of important antimicrobials to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Bernadette Dunham, DVM and director of the FDA’s Center for Veterinary Medicine.

“We realize that these steps represent changes for veterinarians and animal producers, and we have been working – and will continue to work – to make this transition as seamless as possible.”

Drug manufacturer Zoetis said in a statement that it supports the FDA’s efforts “to voluntarily phase-out growth promotion indications for medically important antibiotics” and the company has taken action to implement both guidance documents.

“We believe that veterinarians should be involved in decisions regarding antibiotics use in food animals for the health of the animal and the safety of the food supply.”

Dr. Mike Apley with veterinary clinical sciences at Kansas State University, said the VFD policy had significant input from veterinarian groups. “The proposed rule details how they intend to modify the VFD process to make record-keeping more friendly and less cumbersome for a vet to provide a veterinary feed directive.”

The VFD draft also allows states to define the vet-client relationship, including how frequently producers must seek consultation on using drug products. This will provide producers greater access to veterinarian care amid today’s shortage of licensed vets.

Apley said the proposed VFD rule doesn’t automatically label VFD products as “category 2” drugs as is the current practice, which would have required that these feed additives could only be processed through a licensed feed mill. This will have the effect of not limiting the availability of current over-the-counter feed additives, which will become VFD drugs.

Apley added, “A company still has the option to demonstrate that the current growth promotion regimen has efficacy for prevention, control, or treatment of disease. They would have to show this through supporting information for the new claim and it would have to be accepted by the FDA Center for Veterinary Medicine.”

Apley said many drug manufacturers are expected to follow FDA’s voluntary guidelines.

“I would have a hard time thinking any of these companies would say, ‘you’ve got to make us do it.’ But we’ll know before too long.

“All these companies want to get drugs confirmed in the future. To buck this now is probably not a good idea.”

PHOTO
New FDA rules will stipulate that companies manufacturing antibiotics no longer label them for use in helping cattle grow and gain. Staff photo.