Washington — An FDA-ordered ban of extra-label use of cephalosporin antimicrobial drugs could be delayed after nearly 300 comments poured
in during an extended period for them.
"The agency is carefully reviewing the comments and evaluating any additional data that might have been submitted during the
comment period to determine whether we need to revisit our conclusions," says Laura Alvey, an FDA spokeswoman.
On July 3, FDA prohibited the extra-label use of cephalosporin antimicrobial drugs in food-producing animals "to help
further protect consumers against antimicrobial-resistant strains of zoonotic, foodborne bacterial pathogens."
The original order was to go into effect Oct. 1, but the public-comment period was extended to Nov. 3 at the urging of interested
parties. The effective date was moved to Nov. 30.
"If a decision is made to delay or otherwise place in abeyance implementation of the order, FDA will issue a separate notice
in the Federal Register to that effect prior to Nov. 30," Alvey said at press time.
The American Veterinary Medical Association (AVMA) and many of the food-animal-producing groups took issue with the ruling,
including the American Association of Bovine Practitioners (AABP).
"The AABP has serious concerns about the scope and scale of the prohibition on extra-label drug use of cephalosporin drugs
in food animals," the group told the FDA in its official comment submitted by Dr. Gatz Ridell, executive director. "We believe
that the proposed inclusive ban on extra-label drug use for the entire class of cephalosporin drugs and for all food-producing
animals has not been scientifically justified. We believe that this is especially true for cephalosporin use in cattle. Furthermore,
such a comprehensive ban would have a substantial adverse impact on cattle welfare."
AABP wants to work with the FDA and other veterinary organizations to develop a scientific approach to limit extra-label use
AVMA recommended FDA postpone its final rule "in order to perform a risk assessment characterizing the hazards, evaluating
the risk and ascertaining the impact or any risk-management recommendations should extra-label cephalosporin be prohibited."
The AVMA based its recommendation on a lack of scientific evidence showing any significant risk to human health, lack of any
benefit to human health, unintended consequences on animal health and welfare, food safety and the practice of veterinary
medicine and the possibility of misinterpretation of federal regulations.
Other groups, such as the American Association of Swine Veterinarians, concurred for similar reasons, but the swine veterinarians
also suggested modifying the existing order without "unduly encumbering veterinarians in their efforts to provide effective
treatments for their patients," offering the following suggestions:
» Continue to allow the extra-label use of veterinary cephalosporins in accordance with AMDUCA
» Continue to work with the Centers for Disease Control (CDC), Department of Agriculture (USDA), pharmaceutical manufacturers
and stakeholder groups to explore the implications of antimicrobial use in humans, companion animals and food animals with
regard to the development of resistant organisms
» Establish regulations in an open and transparent manner based on the results of scientific data and risk-based assessments
» Establish and promote a streamlined, efficient process by which pharma-ceutical manufacturers might add supplemental indications
to existing label claims to reduce the need for extra-label use.