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Cefquinome and Antibiotic-Resistant Bacteria

cefquinome.jpg Cefquinome is an antibiotic (made by Intervet, Inc.) that the FDA may soon approve for use in cattle. Usually, this wouldn’t cause much of a stir outside the medical or veterinary industries, but according to the Washington Post, approval of cefquinome may have negative consequences on a global scale. Some doctors fear that overuse of the powerful antibiotic may speed the evolution of drug-resistant bacteria. Proponents argue that the risk outweighs the reward. But a curious point is that FDA’s own advisory board rejected approval of cefquinome last fall (in a non-binding resolution), and a number of health organizations, including the American Medical Association, have also come out against it. According to the Post article, a recently implemented “guidance document” called “Guidance for Industry #152,” codifies how the FDA should weigh the risk/reward of new animal drugs. In an excerpt from the article:
The wording of "Guidance for Industry #152" 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 pharmaceutical companies than is recommended by the World Health Organization. Cefquinome's seemingly inexorable march to market shows how a few words in an obscure regulatory document can sway the government's approach to protecting public health.
It'll be interesting to see how or if this'll play out in a more visible public forum. It should be noted that no antibiotic from the class in which cefquinome belongs has been approved in the U.S. for animal use.

"FDA Rules Override Warnings About Drug," Washington Post, March 4, 2007
Reuters Synopsis of above article
"Introduction to Cefquinome (CEQ) and Overview of Microbial Safety Assessment" (FDA information page)
FDA Guidelines: Guidance for Industry #152" (PDF)

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This page contains a single entry from the blog posted on March 5, 2007 12:50 PM.

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