In a final guidance issued Dec. 11, the FDA laid out a plan for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of products to remove such production indications as “growth promoting,” etc. The plan also calls for changing the current over-the-counter status to bring the remaining appropriate therapeutic uses under veterinary oversight and requiring a prescription for use.
Once a manufacturer voluntarily makes the changes, its medically important antimicrobial drugs may no longer be used for animal production purposes, and their use to treat, control, or prevent disease in animals will require a prescription.
The FDA said it is asking animal pharmaceutical companies to notify the agency of their intent to sign on to the strategy within the next three months. The companies would then have a three-year transition period to implement the changes.
“Implementing this strategy is an important step forward in addressing antimicrobial resistance,” said Michael Taylor, FDA deputy commissioner for food and veterinary medicine. “The FDA is leveraging the cooperation of the pharmaceutical industry to voluntarily make these changes because we believe this approach is the fastest way to achieve our goal. Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort.”
In 2010, the FDA called for a strategy to phase out production use of medically important antimicrobial products and to bring the remaining therapeutic uses in animals under the oversight of a veterinarian. The guidance document the F.D.A. issued on Dec. 11, which was previously issued in draft form in 2012, lays out such a strategy and marks the beginning of the formal implementation period.
This past September, the Centers for Disease Control and Prevention (CDC) recommended several steps to slow the development of antibiotic resistant bacteria. Recommendations made by the CDC included only use antibiotics to treat disease. Another step the agency offered for consideration would be to put a tracking program in place to gather data on antibiotic-resistant infections and the causes of the infections. From such an effort, the CDC said strategies may be developed to lessen the spread of antibiotic resistant bacteria.
The National Chicken Council (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, said Ashley Peterson, Ph.D, NCC vice president of scientific and regulatory affairs "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,” she added.
"We strongly support the responsible and judicious use of FDA-approved antibiotics and the involvement of veterinarians in raising healthy chickens,” she said. “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,” she continued. “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," she concluded.
The American Meat Institute also welcomed today’s publication of the FDA’s final Guidance 213 and proposed 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 Betsy Booren, AMI chief scientist.
“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,” she added.
“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,” she concluded.