Hearing To Examine Withdral Of Poultry Antibiotic
The Food and Drug Administration will hold a hearing on the safety of enrofloxacin for use in poultry. In 2000, FDA's Center for Veterinary Medicine proposed to withdraw this approval. Enrofloxacin, trade name Baytril, is a fluoroquinolone. It is a product of Bayer Corp., Shawnee Mission, Kan.
Bayer's product is approved for treating chickens and turkeys for certain bacterial infections.
In its October 2000 proposal, CVM said the use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistant Campylobacter bacteria in poultry, and that these fluoroquinolone-resistant Campylobacter bacteria are transferred to humans and cause the development of fluoroquinolone-resistant Campylobacter in humans. Further, CVM said, fluoroquinolone-resistant Campylobacter infections in humans are a health hazard.
FDA's Administrative Law Judge, Daniel J. Davidson, will preside over the hearing.
Judge Davidson has scheduled a pre-hearing conference with Bayer and FDA for April 8 in Conference Room F at the FDA Headquarters, 5600 Fishers Lane, Rockville, Md. 20857. At that conference, Judge Davidson will schedule the hearing.
Any interested party can participate in the hearing but must file a notice of participation by March 22, 2002. See the February 20, 2002, Federal Register for more information, or contact Robin Thomas Johnson, Office of Policy (HF-26), FDA, 5600 Fishers Lane, Rockville, Md. 20857, 301-827-3480.
