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KEYCODE BAYER #128

Mar 16, 2004

Judge Rules Against Bayer on Poultry Antibiotic

Drug maker Bayer on Tuesday lost an appeal of the U.S. government's proposed ban of a poultry antibiotic that regulators partly blame for a rise in drug-resistant germs that infect people.

Bayer still has a chance to convince the Food and Drug Administration that the drug, Baytril, is an important therapy for treating sick chickens and should stay on the market.

The company is contesting an FDA proposal made in 2000 to outlaw Baytril, part of a family of potent antibiotics known as fluoroquinolones that doctors consider valuable for treating food poisoning and other serious infections in people.

An FDA administrative law judge on Tuesday ruled in favor of the ban, FDA and Bayer officials said.

Health officials argue that widespread use of Baytril by livestock farmers is one reason more germs are becoming resistant to other fluoroquinolones.

Bacteria learn to outsmart antibiotics when repeatedly exposed to the medicines. Humans then pick up drug-resistant bacteria when they eat or handle contaminated meat.

Since the mid-1990s, when farmers started using fluoroquinolones to fight infections in poultry, researchers have seen the drugs become less powerful against Campylobacter, a bacteria that causes food poisoning.
Campylobacter infections can be life-threatening to elderly people and others with weak immune systems.

Bayer plans to appeal the judge's decision to the FDA commissioner, who has the authority to make the final decision, company spokesman Bob Walker said.

New research shows Baytril helps provide for a healthy food supply "and we don't believe that scientific evidence was fully considered" by the administrative law judge, Walker said.

Walker said Baytril is used only in very small quantities only as a last resort. He said he could not disclose sales figures.

A coalition of consumer groups called Keep Antibiotics Working praised the judge's ruling and called on Bayer to voluntarily comply with the FDA's proposal.

"Bayer wanted a hearing and got it. Enough is enough," Rebecca Goldburg, senior scientist with Environmental Defense, said in a statement. By Lisa Richwine

Keep Antibiotics Working Praises Ruling Upholding Proposed Ban of Cipro-Like Drugs for Poultry; Urges Bayer to Comply with Ban

3/16/2004, U.S. Newswire/ -- The Keep Antibiotics Working (KAW) coalition praised the decision issued today by a U.S. Food and Drug Administration (FDA) Administrative Law Judge upholding the agency's proposal to ban use of Cipro-like drugs in poultry. The drug in question, trade name "Baytril," is made by Bayer Corp. and is almost identical to Cipro. Both are members of the fluoroquinolone class of antibiotics.

FDA showed that use of Baytril in poultry reduces the effectiveness of Cipro in treating Campylobacter, the most common cause of severe bacterial food poisoning. Data from the Centers for Disease Control and Prevention show that resistance to Cipro in Campylobacter in humans has recently risen to 19 percent; when Cipro-like drugs were first approved for use in poultry in 1995, such resistance was negligible. Although Bayer claimed that Baytril is critical for poultry production, that argument was undercut by the fact that six top poultry producers have announced that they no longer use these drugs in chickens produced for human consumption. Major chicken purchasers, including McDonald's, have instructed their suppliers to stop using fluoroquinolones.

"Bayer should stop fighting the proposed ban, and immediately withdraw Baytril from the market with no further delaying tactics," said David Wallinga, M.D., with the Institute for Agriculture and Trade Policy. "Today, nearly four years after the FDA first proposed to ban use of Cipro-like drugs in poultry, rates of Cipro resistance in bacteria that cause severe food poisoning are disturbingly high, and the science linking use of Baytril in poultry to such disease is stronger than ever."

Chicago-based Abbott Laboratories, the only other producer of Cipro-like drugs for poultry, complied with the ban when it was first proposed in October 2000. In contrast, Bayer fought the proposed ban, delaying action for three years to date. FDA regulations allow Bayer to appeal the Administrative Law Judge's decision to the FDA Commissioner, who would then have to review it before affirming or reversing the Administrative Law Judge's decision. That process could take months or years, during which time Baytril would remain on the market.

"Bayer wanted a hearing and got it," said Rebecca Goldburg, Ph.D., senior scientist with Environmental Defense. "Enough is enough. We call on Bayer to live up its slogan 'Expertise with Responsibility,' and voluntarily comply with the ban immediately to protect public health."

Contact: Sean Crowley, 202-478-6128 or 202-550-6524(cell), scrowley@mrss.com , for Keep Antibiotics Working
http://www.KeepAntibioticsWorking.com