Talk about questionable priorities. The FDA is on track to approve a new antibiotic to treat a pneumonia-like disease in cattle, despite warnings from health groups and a majority of the agency’s own expert advisers that the decision will be dangerous for people, according to a disturbing report this morning in The Washington Post.

The drug, called cefquinome, belongs to a class of highly potent antibiotics that are among the last defenses against several serious human infections. A company called InterVet developed cefquinome to treat bovine respiratory disease, the most common disease in cattle. No drug from the class has been approved in the US for use in animals.

But the American Medical Association and other health groups warned the FDA that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotics. This has happened with other drugs. Those super-microbes could then spread to people. Echoing those concerns, the FDA’s advisory board last fall voted to reject the request by InterVet to market the drug for cattle.

Yet it appears the FDA will approve cefquinome this spring. That outcome is all but required, officials say, by a recent “guidance document” that codifies how to weigh threats to human health posed by proposed new animal drugs. The wording of the guidance was crafted within the FDA after a long struggle. In the end, the agency adopted language that, for drugs like cefquinome, is more deferential to drugmakers than is recommended by the World Health Organization.

Stephen Sundlof, who heads the FDA’s veterinary medicine center, says the advisory panel vote isn’t binding, the agency must consider only the guidance and there’s no way to restrict off-label use. The upshot: cows are marginally safer, humans are more vulnerable.

Got milk? Nah. Just bad judgment.

[tags]Antibiotics, Cefquinome, FDA, Veterinary Medicine[/tags]