The Food and Drug Administration (FDA) is implementing a voluntary plan with industry to phase out the use of certain antibiotics for enhanced food production.

“Because all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary,” the FDA said in a statement. “Governments around the world consider antimicrobial-resistant bacteria a major threat to public health. Illnesses caused by drug-resistant strains of bacteria are more likely to be potentially fatal when the medicines used to treat them are rendered less effective.”

FDA is working to address the use of “medically important” antibiotics in food-producing animals for production uses, such as to enhance growth or improve feed efficiency. These drugs are deemed important because they are also used to treat human disease and might not work if the bacteria they target become resistant to the drugs’ effects.

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

FDA is issuing a final guidance document that explains how animal pharmaceutical companies can work with the agency to voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products, and move the therapeutic uses of these products from over-the-counter (OTC) availability to marketing status requiring veterinary oversight.

Once manufacturers voluntarily make these changes, the affected products can then only be used in food-producing animals to treat, prevent or control disease under the order of or by prescription from a licensed veterinarian.

“This action promotes the judicious use of important antimicrobials, which protects public health and, at the same time, ensures that sick and at-risk animals receive the therapy they need,” says CVM Director Bernadette Dunham, DVM, Ph.D. “We realize that these steps represent changes for veterinarians and animal producers, and we have been working to make this transition as seamless as possible.”

To help veterinarians and producers of food-producing animals comply with the new terms of use for these products once the recommended changes are implemented, FDA is proposing changes to the Veterinary Feed Directives (VFD) process. This is an existing system that governs the distribution and use of certain drugs (VFD drugs) that can only be used in animal feed with the specific authorization of a licensed veterinarian. Flynn explains that feed-use antibiotics that are considered medically important and are currently available as OTC products will, as a result of implementation of the guidance document, come under the VFD process.

The proposed changes to the VFD process are intended to clarify the administrative requirements for the distribution and use of VFD drugs and improve the efficiency of the VFD program. Such updates to the VFD process will assist in the transition of OTC products to their new VFD status.

Several meat trade associations have issued statements in regards to the FDA statements.

“[The American Meat Institute] welcomes today’s publication of the Food and Drug Administration’s final Guidance 213 and proposed Veterinary Feed Directive (VFD) rule which establishes a three year timeframe for phasing out growth promotion uses of antibiotics important in human medicine and phasing in veterinary oversight of these products,” said AMI Chief Scientist Betsy Booren. “AMI strongly supports the prudent and judicious use of antibiotics in food animal production under the care of a veterinarian, as defined by the American Veterinary Medical Association, which is consistent with protecting both animal and public health, ensuring the ability to medically treat animals, and maintaining the highest standard of animal welfare practices and we believe Guidance 213 adheres to these principles.

“AMI is committed to working with the FDA over the next three years as this Guidance is implemented and beyond with research for therapeutic options and further understanding how resistance is developed and transmitted among humans, animals, and other living organisms.  AMI will also work with groups throughout the industry and other allied stakeholders to achieve these objectives.”

National Chicken Council (NCC) Vice President of Scientific and Regulatory Affairs Ashley Peterson, Ph.D., released the following statement: 

"NCC appreciates the open and collaborative process FDA has undertaken to phase out the use of subtherapeutic, or growth-promoting uses, of antibiotics that are medically important in treating humans. 

"We strongly support the responsible and judicious use of FDA-approved antibiotics and the involvement of veterinarians in raising healthy chickens.  In fact, in raising chickens today, chicken farmers already maintain close relationships with licensed veterinarians who interact on a routine basis, with the farmers and their chickens, to provide the best care possible for the flock.     

"Antibiotics are not always used in raising chickens; rather, they are administered only when needed and on those occasions, they are used judiciously under the care of a veterinarian.  For those antibiotics that are FDA-approved for use in raising chickens, the majority of them are not used in human medicine and therefore do not represent any threat of creating resistance in humans.

"That being said, we realize that there are strong emotions and conflicting views on the issue of antibiotic resistance – an issue that is very complex, and not black and white.  For that reason, NCC has supported and will continue to support FDA's Guidance 213 and VFD process and we will continue to work with our members and the agency on implementing this policy."

Sources: FDA, AMI, NCC