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US: FDA calls off ban on animal antibiotics

10.dec.08, Wall Street Journal
Alicia Mundy and Jared Favole

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. 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.

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Posted by OFAC on July 21st, 2009 :: Filed under Animal health,Regulations
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