March 17, 2004



Bayer Loses Poultry Antibiotic Appeal


Bayer lost an appeal to overturn the US government's proposed ban on a poultry antibiotic that allegedly leads to the 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.

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