001206 FDA Ban on Poultry Drug Challenged

Washington - A major drug manufacturer 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.

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.

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