Despite warnings, FDA may give green signal to cattle drug

Regulators of Food and Drug Administration (FDA) are expected to approve a controversial antibiotic for cattle in spite of the facts that the drug could harm human health, according to a report published in The Washington Post.

The U.S. health agency got the application from the InterVet Inc., a Millsboro, Delaware based company, for the approval of the drug, called cefquinome. The drug company sought FDA approval to market Cefquinome for treatment of a pneumonia-like disease.

Cefquinome drug is a fourth-generation cephalosporin, a class of highly potent antibiotics used for a range of serious human infections including serious gastrointestinal diseases in children and meningitis. FDA has not yet approved any drug from that class for use in animals in the United States.

But now, despite the warnings that using such drugs in animals can lead to the emergence of new drug-resistant "superbugs" which could then spread to humans, the health agency is likely to grant the application because of a recently implemented guidance document called "Guidance for Industry No.152" that codifies how to weigh threats to human health posed by proposed new animal drugs.

Besides the American Medical Association and about a dozen other health groups which warned that giving cefquinome to animals would probably speed the emergence of microbes resistant to that important class of antibiotic, the FDA's own advisers, the Veterinary Medical Advisory Committee, echoed such concerns when they voted in September to reject the drug maker’s request to market the drug for cattle.

The excessive use of antibiotics in both humans and animals has already helped super-microbes progress, and infectious disease experts have been warning doctors to use the antibiotics more wisely.

The post quoted experts saying the rule is putting pressure on FDA regulators to approve the use of a new animal drug unless it shows conclusive evidence that using the drug in animals will affect humans.

Giving an example of the approval of two powerful drugs in the 1990s for use in poultry that lead to a drug-resistant strain of campylobacter, a critic, Edward Belongia, who is an epidemiologist at the Wisconsin-based Marshfield Clinic Research Foundation, said, "The industry says that 'until you show us a direct link to human mortality from the use of these drugs in animals, we don't think you should preclude their use.'

"But do we really want to drive more resistance genes into the human population? It's easy to open the barn door, but it's hard to close the door once it's open," the Post cited Belongia as saying.

InterVet, the developer of cefquinome, has produced the drug to treat bovine respiratory disease, the most common disease in cattle. A number of effective antibiotics already exist in the market to deal with the respiratory syndrome that generally emerges in cattle raised on intensive farms or when they are packed into trains for shipment.