After five years of debate about human health concerns, the FDA ruled Thursday that an antibiotic made by Bayer Animal Health in Shawnee cannot be used for treating poultry.
Food and Drug Administration Commissioner Lester Crawford, a veterinarian, agreed with evidence that widespread use of Baytril led to antibiotic-resistant pathogens.
He said the evidence showed it made the human version of the antibiotic less effective for treating bacterial food poisoning in humans caused by those pathogens. The food-borne illnesses often are contracted when handling raw poultry.
The FDA’s Center for Veterinary Medicine has been trying since October 2000 to ban the antibiotic drug, which is used to treat respiratory illnesses in chickens and turkeys but is similar to Cipro, a form of human antibiotic. Poultry producers sometimes would put the drug in drinking water, treating entire flocks when a few birds got sick.
The ruling, which takes effect Sept. 12, is the first time the government has pulled an animal drug because it creates antibiotic-resistant pathogens.
Bob Walker, a spokesman for Bayer Animal Health, said the company was surprised and disappointed by the ruling, and was “meticulously studying the 126-page report” before deciding what response it might take.
“It is not about sales. It is about the stance on science and for the industry,” Walker said. “Bayer is a company that in general is committed to science and scientific evidence and everything we have seen pointed to its continued use.”
Walker acknowledged that part of the fight had to do with the precedent set by the ban in the face of what Bayer saw as supporting science for continued use.
Abbott Laboratories in Illinois voluntarily removed its version of the drug from the market, but Bayer contested the FDA’s data and appealed the decision. While Bayer has declined to comment on its sales of the drug, Abbott has estimated that the total U.S. market for the drug is about $15 million.
Supporters of the ban said the ruling would help keep Cipro effective for treating the most serious cases of food poisoning.
“This ruling is a good step forward to protect the public by making sure this essential drug stays effective for treating humans,” said David Wallinga, a senior scientist and director of the Antibiotic Resistance Project at the Institute for Agriculture and Trade Policy in Minneapolis. The group is part of Keep Antibiotics Working , a coalition that had been trying to limit the use in animals of the class of antibiotics known as fluoroquinolones.
For years, public health officials have warned that by allowing wide use of antibiotics in animal feeds, pathogens would become immune to them. Then common medicines for humans would no longer work when those pathogens made people sick.
In 2000, the FDA cited studies suggesting that after the animal antibiotic was introduced in 1995, the percentage of people who got sick from pathogens that resisted common antibiotics went up significantly.
The issue landed on Crawford’s desk last year after Bayer appealed an administrative judge’s finding that the drug should not be used in poultry.
Because of the ongoing health debate, a number of poultry producers have announced they no longer use the drugs in chickens produced for human consumption. A number of restaurant chains have said they told their suppliers not to use the drug on chickens they buy.