FDA Acts to End Antibiotic Resistance13 December 2013
US - A plan has been put forward to phase out the use of medically important antimicrobials in food animals to improve growth or improve feed efficiency.
The plan by the Food and Drug Administration is also expected to phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.
Certain antimicrobials have historically been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes such as using less food to gain weight.
Some of these antimicrobials are important drugs used to treat human infection, prompting concerns about the contribution of this practice to increasing the ability of bacteria and other microbes to resist the effects of a drug.
Once antimicrobial resistance occurs, a drug may no longer be as effective in treating various illnesses or infections.
Because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary. The plan announced today focuses on those antimicrobial drugs that are considered medically important (i.e., are important for treating human infection) and which are approved for use in feed and water of food animals.
In a final guidance issued yesterday (11 December), the FDA lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications. The plan also calls for changing the current over-the-counter (OTC) status to bring the remaining appropriate therapeutic uses under veterinary oversight. 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 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.
"Implementing this strategy is an important step forward in addressing antimicrobial resistance. 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," said FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor. "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
In order to help phase in veterinary oversight of those drugs covered by the guidance that are intended for medically appropriate uses in feed, the FDA also has issued a proposed rule to update the existing regulations relating to Veterinary Feed Directive (VFD) drugs. The use of VFD drugs requires specific authorization by a licensed veterinarian using a process outlined in the agency’s VFD regulations. The VFD proposed rule is intended to update the existing VFD process and facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements 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.
"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, PhD, 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."
However, the measures have ben criticised by congresswoman Louise Slaughter.
She said: "The FDA’s voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.
“Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis.”
National Chicken Council (NCC) Vice President of Scientific and Regulatory Affairs Ashley Peterson, backed the FDA proposals.
He said: "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."
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