The U.S. Food and Drug Administration (FDA) on Wednesday published its Final Guidance 213 and proposed Veterinary Feed Directive (VFD) rule.  FDA’s Guidance 213 implements a plan to phase out over a three-year period the subtherapeutic use of medically important antibiotics in food-producing animals.  The proposed VFD rule updates the existing regulations relating to VFD drugs and is intended to update the existing VFD process and facilitate expanded veterinary oversight to ensure that all antibiotics that are administered to food-producing animals will be done so under the supervision of a veterinarian.  The proposed VFD rule is open for public comment for 90 days starting today.

In response to FDA’s actions, National Chicken Council 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.”

In its final guidance, FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of their products.  The plan also calls for changing the current over-the-counter status to bring the remaining appropriate therapeutic use under veterinary oversight.  Once a manufacturer voluntarily makes these changes, its medically important antimicrobial drugs can no longer be used for food production purposes, and their use to treat, control or prevent disease in animal will require veterinary oversight.

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.  “Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort,” said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor in a press release.

“This action promotes the judicious use of important antimicrobial to protect public health while ensuring that sick and at-risk animals receive the therapy they need,” said Dr. Bernadette Dunham, director of 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.”