What are FDA officials thinking?

The FDA is poised to approve a front-line antibiotic used for mengingitis and other human infections for use in cattle, according to a report in Sunday’s Washington Post. Approval of the antibiotic could lead to antibiotic resistance developing in animals, and then spreading to people.

Apparently the agency is not thinking; it seems instead to be following a ‘guidance document’.

And that document goes against the advice of the agency’s own scientific experts, the American Medical Association and about a dozen other health groups.

These health groups point to evidence that antibiotic use in animals is linked to the development of antibiotic resistance in the human population. In fact, an FDA advisory committee voted 6 to 4 against approving animal use of the antibiotic, cefquinome, a fourth-generation cephalosporin.

Nonetheless, Stephen Sundloff, the head of the FDA’s Veterinary Medicine Center, told panel members that their vote was “not binding”. Instead, he told the committee that the FDA was bound by “Guidance for Industry #152” which limits bans on antibiotic use in animals; the details are a bit mind-numbing but it seems that it’s only easy to ban an antibiotic for animal use if the drug threatens treatments for food-borne illnesses.

That’s way too narrow a definition, given the ability of bacteria to exchange resistance genes. Let’s hope that, in the end, the FDA is able to make a common-sense and scientifically sound decision.