Internal conflict at Health Canada and a link to increased resistance to antibiotics have stalled approval of a drug meant to treat pneumonia in cattle.
Bayer Animal Health first sought approval for Baytril in Canada from the bureau of veterinary drugs in 1996. It has been in use in the United States for cattle and poultry for the last three years and in Europe for a decade.
The approval process can take anywhere from one to 10 years, said Ryan Baker of Health Canada.
“Until we’re entirely satisfied that this drug is safe and effective, we’re not going to approve it,” said Baker. He cited recent concerns with its use in poultry in the U.S.
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Baytril contains enrofloxacin, part of the fluoroquinolone family commonly used to treat human infections. The concern is that germs chickens carry and pass on to humans like campylobacter, a leading cause of food-borne illnesses, are becoming resistant to fluoroquinolone.
Bayer believes the American poultry situation is clouding the issue in Canada for its use in cattle, where no link has been documented.
Don Wilson, a director with Bayer Animal Health, said Baytril is a therapeutic treatment for ailments like shipping fever. It is not a growth promoter or feed additive.
He believes there is disagreement among Health Canada reviewers examining the drug, further bogging down its approval. Some reviewers have disagreed with management, who have not taken a stand.
“We keep patiently waiting for the process to work but it seems the process has been hijacked,” he said. “We are caught, Canadian veterinarians are caught and cattle producers are caught.”
Under watchful eye
Veterinarian Ron Clarke believes all drugs used in animal and food production are coming under greater scrutiny by a broader community.
As a member of a Canadian Cattleman’s Association health committee, he said concerns about antibiotic resistance will drive the way food animals are produced.
“There are decisions being made not on science that have a severe impact on the industry,” he said. “It’s hard enough to make a buck in the industry and we don’t want to be denied any of these tools.”
Clarke fears difficulties in getting products approved will lead to fewer products available to treat ailments.
“If it becomes any more difficult to bring them into Canada, a small market, it isn’t going to happen.”
For now, vets are not hindered by the lack of Baytril on the market because they have other products available, but that could change.
“That’s a luxury quickly coming to an end,” Clarke said.