FDA calls for hearing on Baytril

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FDA calls for hearing on Baytril

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Apr 01, 2002

Rockville, Md.-The Food and Drug Administration (FDA) granted Bayer a hearing to determine the fate of enrofloxacin for use in poultry, the first time since the 1980s a hearing of this type has been granted.

FDA's Center for Veterinary Medicine is concerned about data surrounding the emergence of fluoroquinolone-resistant Campylobacter and its potential impact to human health.

The company contends that any decision by FDA should be science-based. It adds that the evidence on the emergence of fluoroquinolone-resistant Campylobacter is not conclusive, and that data from the government's National Antimicrobial Resistance Monitoring System (NARMS) doesn't show increasing antibiotic resistance. This new evidence was the reason FDA granted the hearing.

John Payne, senior vice president of Bayer Animal Health, says in an interview with DVM Newsmagazine, "Bayer is committed to this process, because we strongly believe that we have to judge this matter on science and not let special interest groups or politics dictate policy."

Payne adds that Bayer has been under intense pressure from lobbying groups attempting to get the company to withdraw the product. "We have been under siege by special interest groups to get us to withdraw our product voluntarily." He says the company has received thousands of letters and e-mails from groups like Keep Antibiotics Working.

"What we are constantly finding is new evidence and new data that refute everything the government has charged on this issue," he adds.

In 2000, the FDA Center for Veterinary Medicine proposed to withdraw approval of enrofloxacin, a fluoroquinolone with the trade name, Baytril. This product is approved for treating chickens and turkeys for bacterial infections. Bayer contested the proposed ruling, and FDA's latest move granted the company a hearing.

Veterinary medicine is watching the outcome closely, officials say, due to potential precedent-setting implications for all of animal health.

In its proposal, CVM states the use of fluoroquinolones in poultry causes fluoroquinolone-resistant Campylobacter bacteria to develop in poultry, which in turn poses more risks to human health.

FDA's Administrative Law Judge Daniel J. Davidson, will preside over the hearing, which officials anticipate sometime this summer. A pre-hearing conference is scheduled for April 8.

The notice states, "CVM has concluded, based on data from surveillance programs, published literature and other sources, that the use of fluoroquinolones in poultry is a significant cause of fluoroquinolone-resistant Campylobacter on poultry carcasses and therefore a significant cause of fluoroquinolone-resistant Campylobacter infections in humans."

Weak evidence

Dr. Lyle Vogel, director of scientific activities for the American Veterinary Medical Association (AVMA), says, "It will set a precedent for the level of scientific evidence necessary to withdraw a veterinary therapeutic drug."

Consumer groups charge FDA with taking too long to withdraw a drug, but, Vogel adds, the withdrawal of any drug is dependent on the strength of the scientific evidence.

Vogel explains, "If the scientific evidence is strong, FDA can withdraw a drug quickly and in those cases the sponsor will not even request a hearing and just withdraw it voluntarily."

Vogel adds, "It is only when the evidence is weak that you get into these drawn out arguments and demands for hearings."

The debate

Payne adds, "FDA had no obligation to grant us a hearing. They are looking for any new data that might conflict with their data to ban the product; is there any new evidence or evidence that they overlooked to get them to possibly change their mind?"

Payne says that Bayer along with Coalition for Animal Health as well as other groups filed information to the FDA docket.

The pre-conference hearing will iron out procedural matters. The company then has until April 22 to submit information for the record and disclose a testimony list for review by the administrative law judge. The next step is scheduling a hearing, and no such date has yet been established.

The administrative law judge will make a recommendation to the FDA commissioner, and then the FDA commissioner makes a decision on it. If the decision is not in favor of the drug sponsor, there is an appeals process.