FDA calls for hearing on Baytril

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 surroundingthe emergence of fluoroquinolone-resistant Campylobacter and its potentialimpact 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-resistantCampylobacter is not conclusive, and that data from the government's NationalAntimicrobial Resistance Monitoring System (NARMS) doesn't show increasingantibiotic resistance. This new evidence was the reason FDA granted thehearing.

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

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

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

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

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

In its proposal, CVM states the use of fluoroquinolones in poultry causesfluoroquinolone-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 overthe hearing, which officials anticipate sometime this summer. A pre-hearingconference is scheduled for April 8.

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

Weak evidence

Dr. Lyle Vogel, director of scientific activities for the American VeterinaryMedical Association (AVMA), says, "It will set a precedent for thelevel of scientific evidence necessary to withdraw a veterinary therapeuticdrug."

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 thescientific evidence.

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

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

The debate

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

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

The pre-conference hearing will iron out procedural matters. The companythen has until April 22 to submit information for the record and disclosea testimony list for review by the administrative law judge. The next stepis 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 isnot in favor of the drug sponsor, there is an appeals process.