Agency Revokes Order Banning Use of Antimicrobial Drugs in Animals
Reversing a position it took in July 2008, the FDA has issued a notice announcing the withdrawal of a final rule that prohibited the extra-label use of cephalosporin antimicrobial drugs in food-producing animals. As we noted in issue 266 of this Update, the FDA issued its prohibition “based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to human health.”
According to the November 26 notice, “The agency received many substantive comments on the order of prohibition. Therefore, to allow more time to fully consider the comments, FDA has decided to revoke the order so that it does not take effect November 30, 2008.” Should the agency again decide to ban use of the drugs, it will provide a public comment period before implementing it.
A number of organizations, including agriculture groups and animal-drug makers, apparently protested the ban, claiming that the antibiotics are needed to prevent infectious diseases in animals and that data about human impact used to support the ban were flawed. A spokesperson for the Association of Swine Veterinarians was quoted as saying, “You have to give the FDA credit for its good-faith response to our concerns.”
Public health officials and the American Medical Association supported the ban out of concern that excessive drug use in food animals can promote resistance and produce bacterial strains that threaten human life. As recently as September, FDA’s director of veterinary drugs, Steven Vaughn, reportedly said during an agricultural conference that antibiotic-resistant bacteria are becoming more common in cattle.
Keep Antibiotics Working, a group that seeks to end the overuse of antibiotics, responded to the revocation by calling on the FDA to “work with veterinarians to identify alternatives to extralabel cephalosporin use instead of continuing to allow an entrenched practice they know puts the public at risk.” The group quoted a senior scientist with the Union of Concerned Scientists as saying, “The FDA continues to ignore the mounting body of evidence about the dangerous misuse of human antibiotics in animal production, and instead defers to the
agribusiness interests by putting off this ban.” See Keep Antibiotics Working Press Release, November 25, 2008; The Wall Street Journal, December 9, 2008.
