http://www.washingtonpost.com/wp-dyn/content/article/2007/03/03/AR2007030301311_
pf.html

"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.

Industry representatives say they trust Guidance #152's calculation that
cefquinome should be approved. "There is reasonable certainty of no harm
to public health," Carl Johnson, InterVet's director of product
development, told the FDA last fall.

Others say Guidance #152 makes it too difficult for the FDA to say no to
some drugs.

"The industry says that 'until you show us a direct link to human
mortality from the use of these drugs in animals, we don't think you
should preclude their use,' " said Edward Belongia, an epidemiologist at
the Marshfield Clinic Research Foundation in Wisconsin. "But do we
really want to drive more resistance genes into the human population?
It's easy to open the barn door, but it's hard to close the door once
it's open."

The FDA knows how hard it can be to close that door. In the mid-1990s,
overriding the objections of public health experts from the Centers for
Disease Control and Prevention (CDC), the drug agency approved the
marketing of two drugs, Baytril and SaraFlox, for use in poultry. Both
are fluoroquinolones, a class of drugs important for their ability to
fight the bioterror bacterium that causes anthrax and a food-borne
bacterium called campylobacter, which causes a serious diarrheal disease
in people.

Before long, doctors began finding fluoroquinolone-resistant strains of
campylobacter in patients hospitalized with severe diarrhea. When
studies showed a link to poultry, the FDA sought a ban. But while Abbott
Laboratories, which made SaraFlox, pulled its product, Baytril's
manufacturer, Bayer Corp., pushed back."