FDA ruling on enrofloxacin use in poultry is more than a year away

Apr 17, 2002 (CIDRAP News) – A ruling by the Food and Drug Administration (FDA) on whether to stop the use of enrofloxacin in poultry because of concern about antimicrobial resistance is more than a year away, according to a hearing schedule laid out by an FDA administrative law judge last week.

The schedule issued Apr 10 by Administrative Law Judge Daniel J. Davidson calls for submission of motions, written evidence, and related documents in a series of steps over the next year, leading up to oral cross-examination of witnesses in late April and early May of 2003. The schedule does not project a date for a ruling in the case.

The FDA's Center for Veterinary Medicine (CVM) proposed in October 2000 to withdraw approval of the use of fluoroquinolones in poultry because of concern that it promotes the development of fluoroquinolone-resistant Campylobacter that could be transferred to humans. Bayer Corp, maker of enrofloxacin (Baytril), requested a hearing on the proposal in November 2000. Abbott Laboratories, manufacturer of sarafloxacin (Saraflox), another fluoroquinolone, agreed to stop marketing that drug for use in poultry.

In February 2002, the FDA announced that it would hold a public hearing on the proposal to stop the use of enrofloxacin. The date of the hearing was to be set at a pre-hearing conference scheduled for Apr 8. But Davidson canceled the pre-hearing conference and instead ordered FDA and Bayer lawyers to meet and discuss logistics, including a schedule, according to David Reeder, a Bayer spokesman in Pittsburgh.

Reeder said the schedule proposed by the lawyers was longer than what Davidson ordered. Davidson's order says the proposed schedule would have extended the process well into 2004 and that he revised it "in an attempt to minimize the time needed to complete the hearing stage of this proceeding."

Davidson's schedule calls for motions this week to modify the issues considered in the hearing process. The parties are to exchange witness lists by May 20, continue researching the case over the summer, and propose stipulations in September. They are to submit written testimony and exhibits in December, file proposed findings of fact in March 2003, and file critiques of each other's proposed findings of fact in April 2003.

"The only face-to-face meeting of the parties will be in late April and early May of 2003 for cross-examination of witnesses," said Jon Scheid, an FDA press spokesman in Rockville, Md. That step is scheduled for April 28 through May 9 of 2003, according to Davidson's order. "A schedule for rebuttal, if necessary, and/or the post-hearing briefs will be established at the conclusion of the oral phase of the hearing," the order states.

Davidson's schedule indicates that the Animal Health Institute, a Washington, DC, lobbying organization for companies that produce drugs for pets and farm animals, is a party to the hearing process along with Bayer. The institute has been a defender of the use of antibiotics in farm animals.

The FDA approved the use of enrofloxacin in 1996 to treat certain bacterial infections in poultry. In its proposal to halt this use of the drug, the CVM estimated that in 1999, 9,261 people who had campylobacteriosis and were treated with a fluoroquinolone would have had a fluoroquinolone-resistant illness related to fluoroquinolone use in poultry. Campylobacter is one of the most common causes of foodborne disease. In a Feb 20 Federal Register notice about the hearing process regarding enrofloxacin, the FDA said Bayer "will have the ultimate burden of showing the drug's safety."

Reeder said today, "We believe we have the science to substantiate the value of this drug in protecting the food supply and that it's not a threat to human or public health. We look forward to moving ahead." Asserting that enrofloxacin is used in only about 1% of poultry, he said Bayer will contend that many Campylobacter infections in the United States are related to foreign travel.

See also:

Feb 20, 2002, Federal Register notice of FDA plan for a hearing on enrofloxacin use in poultry
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002b.htm

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