FDA revokes planned extralabel cephalosporin use ban

The Food and Drug Administration decided in late November against implementing a ban on extralabel cephalosporin antimicrobial use in food animals.

"The agency received many substantive comments on the order of prohibition, and therefore, in order for FDA to fully consider the comments, the agency has decided to revoke the order," a Nov. 25 FDA announcement states. "As a result, the order of prohibition will not take effect on November 30, 2008."

The AVMA spoke out against the final rule in late October through a letter to the FDA signed by Dr. Lyle P. Vogel, AVMA assistant executive vice president, for Dr. W. Ron DeHaven, AVMA CEO. The letter states, in part, that the FDA should delay the ban to assess the risks and benefits of using cephalosporin antimicrobials in an extralabel manner as well as the consequences of halting such use.

"The AVMA understands the Order of Prohibition is well-intended; however, it will not have the desired positive impact on human health," the letter states. "Moreover, we believe the Order is more likely to compromise our food safety system."

The FDA issued the order July 3 that would have, by Oct. 1, prohibited extralabel use of cephalosporin antimicrobial drugs in food-producing animals. The ban was intended to preserve antimicrobial effectiveness for treatment of disease in humans.

The FDA agreed in mid-August to extend the comment period to Nov. 1 and, as a result, implement the ban Nov. 30.

FDA spokeswoman Laura Alvey said in November that agency officials were reviewing comments and evaluating additional data to determine whether to revisit their conclusions.

The FDA could issue another order of prohibition after review, but not without another comment period, the FDA announcement states.

"If, after considering the comments and other relevant information, FDA decides to issue another order of prohibition addressing this matter, FDA will follow the procedures in 21 CFR 530.25 that provide for a public comment period prior to implementing the order," the agency states.

The AVMA letter cites a lack of scientific evidence indicating extralabel cephalosporin use in food animals presents a significant risk to humans, a lack of evidence that the ban would benefit human health, the potential for harmful unintended consequences to animals and humans, and a misinterpretation of federal regulations.

The letter notes that Congress authorized extralabel drug use in 1994 through the Animal Medicinal Drug Use Clarification Act. Because animal drug label indications are limited, such use is necessary to relieve pain and suffering of animals.

Extralabel use is an FDA-regulated activity that requires a veterinarian-client-patient relationship, and it is allowed only for therapeutic uses that do not present risks to public health, the letter states.

"Extralabel drug use plays a critical role in veterinary medicine because veterinarians have a relatively limited number of FDA-approved drugs for treatment of the numerous animal species, each with diverse disease conditions," the letter states. "Drug sponsors cannot reasonably be expected to generate labels for all conditions of all animals, though FDA approved labeled indications are very beneficial."

The AVMA was not alone in asking the FDA to reconsider the ban.

Arthur L. Craigmill, PhD, extension toxicology specialist, co-coordinator of the Western Region Minor Use Animal Drug Program, and co-director of the Food Animal Residue Avoidance Databank program at the University of California-Davis, wrote that FDA's cited evidence that the extralabel use of cephalosporin antibiotics has caused or will likely cause an adverse event has not been published in open literature but is inferred.

Dr. Craigmill said a sweeping ban would be especially harmful for minor species such as sheep and goats, for which there are few FDA Center for Veterinary Medicine-approved antibiotics available. A limited ban on extralabel use in a single species or production class could be implemented if widespread extralabel use in that species or class were problematic, as was done with a ban on sulfonamides in lactating dairy cattle.

The American Association of Swine Veterinarians delivered a response that warned the ban could have endangered public health. The letter sent to the FDA says very few antimicrobials are approved to treat conditions in swine, and the overarching ban would leave swine veterinarians with "one less critical category of antimicrobial products from which to choose when deciding how to effectively treat the animals for which they are responsible."

"It is our opinion that the broad ban enacted by FDA will not accomplish the goal of reducing multi-drug resistance in foodborne pathogens," the AASV letter says. "We encourage FDA to seriously consider the impact of this ban on animal health and welfare as well as the potential unintended consequences to food safety, public health and animal suffering."