The Food and Drug Administration Wednesday announced it would implement a plan to phase out the use of medically important antimicrobials in food animals when used to enhance growth or improve feed efficiency.
The proposed plan, which would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs, will be considered in a 90-day comment period starting Dec. 12 on the Federal Register.
According to an FDA statement, the decision comes in response to concerns that some antimicrobials used in livestock production are contributing to antibiotic resistance.
"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," explained Bernadette Dunham, DVM, Ph.D., director of the FDA's Center for Veterinary Medicine.
The plan specifically affects "medically important" antimicrobials – those that are important for treating human infections – and those that are approved for use in feed and water of food animals.
In a final guidance, the FDA issued a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products.
The plan also calls for changing the current over-the-counter status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once a manufacturer voluntarily makes these changes, FDA said, 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 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.
"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," Dunham said.
Also Wednesday, FDA issued a proposed rule to update the existing regulations relating to Veterinary Feed Directive drugs.
The use of VFD drugs requires specific authorization by a licensed veterinarian using a process outlined in the agency's VFD regulations. The new proposed rule is intended to update the existing VFD process and expand veterinary oversight by clarifying and increasing flexibility for the distribution and use of VFD drugs.
Such updates to the VFD process will assist in the transition of OTC products to their new VFD status, FDA said.
Stricter regulation or elimination of antimicrobials for animal use has been discussed several times on Capitol Hill in the past several years; Reps. Henry Waxman, D-Calif., and Louise Slaughter, D-N.Y., have long pushed for legislation to provide more information on the amount and use of antibiotics and other antimicrobials given to animals raised for human consumption.
However, a Centers for Disease Control and Prevention report earlier this year indicated that the widest misuse of antibiotics occurs in hospitals, countering sentiment among critics of antibiotics in agriculture that farms using antibiotics to prevent or treat bacterial infections in animals are the primary driver behind advancing resistance.