-Caveat Lector-
FDA attempt to ban poultry drug challenged
By LAURAN NEERGAARD
The Associated Press
11/30/00 6:57 PM
WASHINGTON (AP) -- A major drug manufacturer on Thursday
challenged the government's attempt to ban an antibiotic given to
poultry -- a ban proposed because of evidence that the drug's use
in chicken causes people to get sick from drug-resistant
bacteria.
Bayer Corp. formally asked the Food and Drug Administration for a
hearing to challenge the proposed ban of its poultry antibiotic
Baytril, an agency spokesman confirmed late Thursday.
At issue are a family of antibiotics called fluoroquinolones.
Some fluoroquinolones are sold to treat animals, but others are a
leading treatment for thousands of Americans who get food
poisoning from campylobacter, bacteria found mostly in chicken.
Cases of antibiotic-resistant campylobacter are rising, federal
health statistics show -- and an FDA investigation concluded that
use of fluoroquinolones in chicken is one significant cause.
In October, the FDA proposed banning the two fluorquinolones used
in poultry. Abbott Laboratories agreed to pull its version, Sara
Flox, off the market immediately.
Bayer did not return calls seeking comment Thursday, but has
called its Baytril an important treatment for sick chickens that
is used only when truly necessary, not widely.
Bayer now has 30 days to provide the FDA with scientific evidence
backing its claim that Baytril should stay on the market. The FDA
can either decide Bayer doesn't make a convincing case and
proceed with the ban -- or can let the company take its dispute
to an administrative law judge, a process that can take several
years.
"Obviously when we put out this notice (of a proposed ban) we
expressed our concern. That concern remains," said FDA spokesman
Brad Stone. But, "we'll look at the data they submit carefully."
Bacteria mutating to resist antibiotic treatment are a growing
health threat that increasingly leaves penicillin and other
infection fighters ineffective. Resistance develops when
antibiotics are overused, either by people or animals.
Sara Flox and Baytril mark the first drugs the government has
moved to withdraw because of antibiotic resistance.
Humans have used fluoroquinolones since the 1980s, but resistance
didn't begin significantly increasing until veterinarians began
using the drugs in the mid-1990s, says the Centers for Disease
Control and Prevention. An estimated 11,000 people will suffer
drug-resistant campylobacter this year, up from 9,000 last year,
the FDA says.
"People have to understand this isn't a chicken issue, this is a
human health issue," said Dr. Tamar Barlam of Center for Science
in the Public Interest, a consumer group that lobbied Bayer to
accept the ban and last week sent a petition signed by more than
180 health professionals.
Copyright 2000 Associated Press. All rights reserved. This
material may not be published, broadcast, rewritten, or
redistributed.
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