Feb 25, 2002 (CIDRAP News) Nearly a year and a half after the Food and Drug Administration (FDA) first proposed to stop the use of enrofloxacin (Baytril, a fluoroquinolone antibiotic) in poultry because of safety concerns, the agency says it plans to hold a public hearing on the proposal. The date of the hearing will be set at a prehearing conference on April 8.
In October 2000, the FDA's Center for Veterinary Medicine (CVM) proposed to withdraw the approval of enrofloxacin for use in poultry because of concern about antimicrobial resistance. The CVM said the use of fluoroquinolones in poultry promotes the development of fluoroquinolone-resistant Campylobacter bacteria in poultry. These resistant bacteria may then be transferred to humans, potentially leading to hard-to-treat infections, the agency said.
Bayer Corp, maker of Baytril, requested a hearing on the FDA proposal in November 2000, according to a Federal Register notice of the plan for a hearing. Daniel J. Davidson, the FDA's administrative law judge, has scheduled a prehearing conference with Bayer for April 8 at FDA headquarters in Rockville, Md. Davidson, who will preside over the hearing, will set the date at the conference, the FDA announcement said.
Parties who want to participate in the public hearing must file a notice of participation by March 22, the FDA said. Information on filing is available in the Federal Register (see link below) or from Robin Thomas Johnson, Office of Policy (HF-26), FDA, 5600 Fishers Lane, Rockville, MD 20857; telephone 301-827-3480.
The FDA approved the use of enrofloxacin in 1996 as a treatment for certain bacterial infections in chickens and turkeys. In its proposal to halt use of the drug in poultry, 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.
Federal Register notice