US FDA denies approving controversial cow drug

WASHINGTON, Mar 5 (Reuters) The US Food and Drug Administration denied that it was about to approve a controversial new antibiotic for cattle that some people fear might harm human health.

And in an unusually strongly worded statement, the agency criticized the Washington Post newspaper for an article that said it was about to do so.

''The Washington Post article made assumptions and drew conclusions that are premature and irresponsible,'' the FDA said.

''At this time, the FDA has made no decision regarding the marketing application for cefquinome.'' The newspaper reported in Sunday's editions that the agency was poised to approve cefquinome, a fourth-generation cephalosporin.

These are a class of antibiotics used for a range of human diseases including serious gastrointestinal diseases in children and meningitis.

The fear is that using such drugs in animals can lead to the emergence of new drug-resistant ''superbugs'' that will be immune to similar drugs when used in people.

The overuse of antibiotics in both humans and animals has already helped such bacteria evolve, and infectious disease experts have been warning doctors to use them more judiciously.

The FDA's own advisers, the Veterinary Medical Advisory Committee, voiced such concerns when they voted in September to reject approval of cefquinome by InterVet Inc of Millsboro, Del, which makes it.

Yet the Post quoted experts as saying the FDA was moving towards approval anyway, overriding the advice of the panel, the American Medical Association and other health groups.

The Post said the FDA was being pressured to approve the drug because of an internal guidance document called ''Guidance for Industry 152'' on how to weigh threats to human health from by proposed new animal drugs.

The FDA said this was not true.

''We are required by law to address the drug's safety and the guidance document 152 provides a structured framework to help with this evaluation. However, FDA is not constrained to follow only the guidance contained in this document 152,'' it said.

''It is inappropriate for the Washington Post to mislead readers, particularly with the article's headline and lead, by insinuating that the agency has made a decision when we have not.'' In January, New York Democratic Rep. Louise Slaughter, a Democrat who chairs the US House of Representatives Rules Committee, sent the FDA a letter asking it not to approve the drug. She is a microbiologist.

She and some other groups have been lobbying to try to keep the FDA from approving the drug.

REUTERS AKJ RN1019