FDA Calls Off Ban on Animal Antibiotics

(Wall Street Journal)



The Food and Drug Administration said it would continue allowing the widespread use of a class of powerful antibiotics in food-producing animals, making a last-minute reversal after calling the practice a public-health risk in July.


The agency's bid this summer to ban many uses of cephalosporin drugs in cows, swine, chickens and other animals came under fire from the industry. Agriculture groups and animal-drug makers, including Pfizer Inc., said the antibiotics are needed to prevent many infectious diseases in animals.


Public-health officials and the American Medical Association are worried that excessive use of antibiotics -- including in animals -- can promote resistance and produce strains of bacteria that threaten human life. Cephalosporins treat respiratory diseases in cattle and swine but are also often given "off-label" for uses not approved by the FDA to poultry or more generally in livestock for non-approved infectious diseases.


On July 3, the FDA announced a planned crackdown on off-label uses in animals, citing "the importance of cephalosporin drugs for treating disease in humans."


That position was reiterated in September by the FDA's director of veterinary drugs, Steven Vaughn. "We have [bacterial organisms] moving around the world that we have never seen before," he told a conference, according to Dairy Herd Management magazine. Dr. Vaughn, who couldn't be reached for comment, told the group that antibiotic-resistant bacteria are becoming more common in cattle.


Groups such as the Animal Population Health Institute, the Kansas Health Department and the National Turkey Federation, objected to the proposed ban. The American Veterinary Medical Association complained to the FDA that the data on the human impact it used to support the ban were flawed.


On Nov. 25, five days before the ban was to take effect, the FDA quietly revoked it with a notice in the Federal Register. The FDA's statement said the agency received many comments and needed more time to review them. A spokeswoman said the agency still could impose restrictions later.


"You have to give the FDA credit for its good-faith response to our concerns," said Tom Burkgren, director of the Association of American Swine Veterinarians. Dr. Burkgren said some of the new diseases striking swine today aren't mentioned on cephalosporin labels, and there are few alternatives.


Keep Antibiotics Working, a group that promotes agriculture-production changes, denounced the FDA's reversal. "They were under a lot of pressure from companies and agriculture, the producers, to end the ban," said the organization's chief, Steven Roach.


Pfizer, whose cephalosporin drug Excede is approved for certain uses in animals, said more time is needed to analyze the risk posed to treatment of animal diseases from cephalosporin restrictions.


The FDA's Center for Veterinary Medicine has been involved in other recent controversies. In June, it abruptly announced it was allowing Wyeth's heartworm drug ProHeart 6 back on the market. It was withdrawn in 2004 amid some 500 reports of dog deaths. 12-09-08







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